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Jobs that Crossed my Desk –Nov. 3 – Nov. 9, 2008
Contact the person whose information appears at the top of each listing. Listings for executive search persons are separted by string of stars. Multiple listings by one recruiter are separated by straight line.*******************************************************************
If you are interested in this position, please contact Natasha Daty at ndaty@qltinc. com.
QLT Plug Delivery, Inc. is a company developing innovative therapies in the field of ophthalmology. QLT Plug Delivery, Inc. is located in Menlo Park, CA and is a subsidiary of QLT Inc. For more information, visit our web site at www.qltinc.com.
QLT Plug Delivery, Inc. is currently looking for a Research Associate/Senior Research Associate with a background in chemistry . This position will fill an important role in the continual development of our proprietary technology.
Job Requirements:Research Associate/ Senior Research Associate · Experienced with characterization of pharmaceutics from R&D or preclinical formulations, including release kinetics, extraction, related compounds· Extensive hands-on use of HPLC for characterization of pharmaceutics, instrument method development, evaluation of literature for translation of methods to the laboratory setting· Preferred experience with Instrumentation: RP-HPLC, normal phase, GPC, UPLC· Wet chemistry experience· Extra points for formulation experience· BS desired *****************************************************ContactGil [email protected] Representative on West Coast
European company is looking for a sales rep (with BS degree) to be based in San Francisco to sell chromatography equipment and instrumentation. Technical sales experience of 3-6 years is desirable.The Sales Rep could be based anywhere on West Coast, not limited to SF. *****************************************************Marilyn Williams, CSAMSenior Account ManagerThe Compass Network9455 Ridgehaven Court, Suite 100San Diego, CA 92123Office: 858-565-6600 x329
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Fax: [email protected]
Position: Senior Development Engineer for a cardiology company in the San Jose area.
Candidates should come with the following credentials:
* Mechanical engineer * Catheter background, or any hand-held devices * Exposure to cardiac electrophysiology or RF * Knowledge of ISO 13485 regulations and FDA QSRs * SolidWorks, Autocad * Bench testing * Animal studies ***************************************************** Jim Brown Associates15 Southwind CircleMarina Bay – The BreakersRichmond, CA 94804-7405Phone: (510) 235-4472FAX: (510) 235-4482e-mail: [email protected]
Position - Product Manager for Bay Area Medical Device Company
Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned):
Develop sales materials and track promotional programs. Manage the current product lines. Analyze sales data and compile competitive information. Interface with R&D to develop line extensions and product improvements. Provide timely and effective communications with the direct and indirect sales force. Assist the sales efforts by creating useful information and materials to increase the
usage of the company’s products. Work with vendors to insure that materials are produced on time and within budget. Provide accurate sales forecasts for manufacturing. Initiate ECNs to update and maintain the current products.
Provide timely information concerning sales trends and performance to budget. Use data to effectively respond to market changes. Provide timely marketing input and assist in the R&D efforts. Provide product information and training for the sales force. Provide regular communications to the sales force, which will increase their
knowledge and selling effectiveness. Act as the main in-house contact to provide technical information and support for the
sales force.
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Utilize knowledge gained from experiences and input from customers and in-house personnel to develop sales programs and support materials to increase the sales of our current products.
Work with the Director of Marketing to develop marketing plans and strategic objectives.
Responsible for implementing marketing and sales strategic plans. Will be responsible for providing marketing input for product enhancements and line
extensions. Develop marketing programs that add value to our products and improve customer
satisfaction and increase sales. Use strong communication and analytical skills to provide sales trends and forecasts.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.
BA or BS degree (MBA preferred). Must have excellent verbal and written communication skills. Requires 2-3 years of medical sales and marketing experience dealing with physicians Must have a good understanding of the medical environment to effectively respond to
market concerns and provide technical support for the company’s products, particularly orthopedic arthroscopic products.
Experienced marketing surgical equipment preferred. Must work well with outside vendors and design companies to produce written
materials, and also with inside personnel across all departments in order to successfully manage the product line. An in-depth understanding of how the products are used and factors that can influence the buying decision is essential. Also requires the ability to make decisions concerning the format and design of product support materials. International medical marketing experience is a plus.
Salary Range: They're looking for candidates in the $80-85K range
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If you or someone you know is interested and qualified please contactLee directly at;
Lee GellinsFortune Personnel of Hilton [email protected]
Process Development role for a medical device company in the bay area.They are looking for a local candidate- want someone with Mechanical orElectrical engineering degree. Med device experience of course- and veryexperienced with controls/automation. At least 5 yrs experience.Process improvements tooling and automationValidations
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six sigma Development life cycle manufacturing processes Experience with materials and plastics helpful
*****************************************************Andrew Youngelson, Healthcare Technology Recruitment Partner Key Recruit Inc.www.keyrecruit.com
Sr. Group Leader
Date Posted: 11/03/2008 Job Id: 1662 Company: We are a worldwide specific pharmaceutical and medicinedelivery/medical device company devoted to improving health by developing,manufacturing and marketing products that help improve the productivity,protection and effectiveness of patient care. We recently acquired anotherPharma company to become the global leader in special injectablepharmaceuticals that happen to be generic. With over 7 decades of service tothe hospital industry, Our portfolio includes one of the industry'sextensive lines of injectables, solutions for medicine management. As wellas infusion therapy. We are also a primary provider of contractmanufacturing services to proprietary pharmaceutical and biotechnologycompanies. Our extensive portfolio of products is used by hospitals andother site providers, such as clinics, home health care providers andlong-term care facilities. Location: Illinois Reports To: Director Product Development Salary: $99K - 110K depending on experience. Education: PhD. Requirements: 6 years experience in pharmaceutical industry withdevelopment of natural-sourced biological or biotechnology-derived products.Must be proficient in the analysis and characterization of carbohydrates andproteins and understand the impact of manufacturing processes on theproducts. Should be familiar with IND, NDA, and BLA submission requirementswith knowledge of GMP and GLP guidelines. Must have excellent verbal andwritten communication skills, be able to work in cross-functional teams, andmaintain project schedules on multiple programs. Duties: The Sr. Group Leader provides technical leadership for theirdirect staff in the development of complex protein and carbohydrateproducts. The primary responsibilities are focused on the analyticalchemistry, manufacturing process, and formulation development activities.They include the assessment of technical challenges for new programs,preparation of detailed development plans, and leading their staff to meetthe projects development goals. The Sr. Group Leader serves on the core
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program team, maintains effective cross-functional communication, andcoordinates activities with other functional areas. *****************************************************
Jobs Listed from Oct. 27-Nov. 2, 2008Please send resume as an attachment to Darshana Nadkarni at [email protected].
Senior Project ManagerAn incubator with several early stage projects/companies has an immediate opening for a Senior Project Manager to join their team in mid-peninsula, CA. This role will report to the CEO and will work with members of various teams to develop and maintain the Master Project Plan, and ensure that projects remain aligned by early anticipation of challenges, resources, guidance and delivery problems as they emerge. This role will manage schedules, plans, documentation and publishing of reports, maintaining communication regarding needs of the projects, and checking in with team members to get things done on schedule. Required, BS in science or engineering and 3+ years experience in medical device R&D product development, and 5+ years experience in project management. Also required, excellent communication skills and ability to instruct others in cross functional teams.*****************************************************
Jim Brown Associates15 Southwind CircleMarina Bay – The BreakersRichmond, CA 94804-7405Phone: (510) 235-4472FAX: (510) 235-4482e-mail: [email protected] Science Liaison - Chicago, IL We have an immediate opening for a Medical Science Liaison to effectively manage the Chicago territory. The MSL position is a field-based scientific and therapeutic expert, who is tasked with the following activities:
Maintain and improve clinical expertise through aggressive education including journal club, attendance at relevant professional educational meetings and scientific workshops, and independent research.
Identify key opinion leaders/industry leaders (KOLs) within a specified therapeutic area/s including current and future therapeutic leaders
Development of professional peer-to-peer relationships with KOLs and other prominent healthcare providers as they relate to both marketed and development pipeline products.
Facilitating, building internal support, and monitoring of investigator-initiated study concepts including; supporting potential investigators concept development and submissions,
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review study design to match internal development plan, contracting, and overseeing milestone requirements to assure progression of for company sponsored protocols.
Identify and communicate key clinical and research issues from KOLs to appropriate departments.
Research and identification of medical community training and educational needs with relevant therapeutic areas.
Participation in medical education for healthcare professionals through presentations at on-site healthcare facilities, investigator meeting, national professional society and conferences, advisory boards, or local and regional healthcare meetings.
When appropriate, collaborate with regulatory and clinical operations to facilitate the recruitment of potential sites for clinical trials and to assist in site location oversight and monitoring.
Serve as team leader or member of MSL team. Teams may include training, medical information, and KOL development. Demonstrate leadership, proactive identification of needs, and task follow-through in a collaborative and matrix oriented approach to assure quality programs.
Complete all internal reporting in an accurate and timely manner.Serve as medical consultants to internal medical information department to assure the
development of quality standard response letters.Adhere to all internal and external guidelines
The MSL must have a valid driver's license, be willing to travel up to 60%, possess excellent presentation and teaching skills with a strong scientific and pharmaceutical knowledge. An advanced degree (MD, PharmD, PhD) is preferred in addition to 2 years of experience as an MSL. CNS and nephrology experience is a plus. The territory is Chicago-based and includes MN, WI, KS, ND, SD, MI, NB, KY, IA and Missouri.
Company provides competitive salary, bonus, company car and a full range of benefits (100% paid for employee & dependents), 401(k), ESPP and stock options.
___________________________________________________________
Sales Analytics Manager
We are looking for an experienced Sales Analytics Manager to independently implement, execute and manage all aspect of sales reporting, secondary market research efforts and the administration of the sales force automation database. This position will also support the Associate Director, Sales and Marketing Analytics in forecast modeling, incentive compensation modeling, sales targeting and various primary market research projects.
Position Duties and Responsibilities
Management of all sales analytics reporting including but not limited to weekly call field activity reporting and monthly demand data reporting
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Execute all secondary market research effortsExtensive relational database management Familiarity with SQL database mining Ability to migrate data across multiple applications Prescription data analysis
Overall management of the Sales Force Automation Database including
Input on forecast modelsInput on incentive compensation modelingMaintenance/Changes to other Access-based databasesAssistance with various primary market research projects
Requirements
The ideal candidate will have a bachelor's degree plus 3 - 5 years experience in the pharmaceutical industry. Significant experience working with relational databases and multiple data filesExperience working with remote sales force automation databaseExcellent computer skills with an emphasis on Access and ExcelPrimary market research experience
Excellent oral/written communication, interpersonal, and organizational skills required.
Preferred
Familiarity with Wolters Kluwer (formerly NDC) data and applicationsFamiliarity with Foxpro Forecast modelingExperience with specialty pharmacy data
***************************************************** Contact:Paul SandersonSanderson Mcleod615-260-3205paul@sandersonmcleo d.com
I am retained to hire an AD pharmacology for a biotech company in Seattle- www.alderbio.com
Associate Director, Pharmacology
This position is responsible for the design and execution of in vivo studies conducted in support of Alder Biopharmaceutical’ s drug discovery and development programs. This individual will take the lead in interfacing with vendors to perform acute and chronic toxicology programs, assess lead candidate pharmacokinetic properties and characterization
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of therapeutic candidate efficacy in the appropriate in vivo setting. In this latter role, the individual will have hands-on responsibilities for heading the internal in vivo characterization efforts. This individual will have in-depth experience running both mechanistic and therapeutic models of cancer and/or inflammatory disease. Lastly, this individual will have the responsibility of drafting technical summary reports concerning the in vivo testing of molecules progressing to IND filings.
Requirements
This position requires a Ph.D., M.D. or D.V.M. and a minimum of 8 years of experience in the pharmaceutical or biotechnology sector. Significant experience in inflammation and cancer in vivo models is required. First hand experience with managing external studies is key. The preferred candidate will need to have contributed to therapeutic antibody IND filings. Strong capabilities in in vivo model design, FACS and ELISA methods are a must. This position requires excellent verbal and written communication skills as well as strong interpersonal skills
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Alejandro Marshall Avature Sourcing Specialistwww.avature.net [email protected] (212) 380-4160 ext.457
Sr Engineer, Lens DesignReq #4583BRJob
DescriptionDesign contact lenses, and support the development of innovative opticalophthalmic medical devices.
Lead and execute contact lens design activities on multi-disciplinaryproject teams, supporting product and process development activities.Prepare and execute lens design plans for such projects, including thedefinition of design features, tolerances, critical design verificationexperiments, and metrology requirements.
Translate product design goals into specifications for novel lensdesigns that support market and business driven requirements. Analyzethese designs using mechanical and optical software tools, and documentresults. Conceive new designs to improve the performance of opticalophthalmic devices.
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Interface with industry and academic experts to establish and leveragenew technologies in support of the realization of new product concepts.Develop competency in the relevant standards, patents and journalliterature relating to the design of optical ophthalmic devices. Provideproduct design support, as required, to the manufacturing and marketingorganizations.
QualificationsMS in Biomedical Engineering, Biomechanical Engineering or MechanicalEngineering.
Either a MS degree with minimum of 3 years relevant experience, or PhDwith minimum of 2 years relevant experience in medical device productdesign and development.
Application of biomedical and optical engineering to the development ofophthalmic optical device, with knowledge in the design of contactlenses and broad understanding of associated functional areas, such asoptics, metrology, optometry, and lens manufacturing.
Self-motivated team player, able to provide technical leadership, aswell as a capable technical contributor.
Strong creative, trouble-shooting and analytical capabilities.Able to conceive ideas, tests, and develop technical solutions in amulti-disciplinary team environment.
Work Location NY - Rochester-1400 N Goodman StreetRelocation Available YesStatus Full-Time_______________________________________Design Engineer#4708BRDescriptionDesign and development of innovative optical ophthalmic medical devices,such as contact lenses and intraocular lens (IOLs), utilizingbiomechanics, materials, and finite element analysis.
As a member of multi-disciplinary product and process developmentproject teams, this role will require the preparation and execution ofdesign plans, including the definition of critical design features,tolerances, verification experiments, and metrology requirements.Analyze data for conformance to design specifications.
Analyze designs using mechanical and numerical analysis software tools
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(e.g., 3D CAD and FEA/FEM), and document results. Simulate themechanical and optical performance of lenses in the eye and correlate tolaboratory tests. Recommend designs to improve the opto-mechanicalperformance of optical ophthalmic devices.
Support research and development of optical ophthalmic medical materialsand devices. Coordinate and perform materials testing of hyper-elasticpolymers and other biomaterials. Support the development andimplementation of test methods for the characterization of contactlenses and IOLs, with an objective of improving the prediction ofbiomechanical and optical performance attributes. Develop and maintaincompetency in the application of biomechanics to the design anddevelopment of contact lenses and IOLs.
QualificationsBS (MS preferred) in Biomechanical Engineering, Mechanical Engineering,or Biomedical Engineering,
2 years experience in mechanical design, preferably in medical productdevelopmentFamiliarity with mechanical drafting (e.g., ProE, SolidWorks, Catia,SolidEdge, RhinoCAD)Experience with finite element modeling (e.g., NASTRAN, ANSYS, Abaqus)Programming skills preferred (e.g., Maple, MATLAB, Mathematica, VisualBasic, C++, Python)Exposure to optics and optical design preferred, but not required.Demonstrated hands-on laboratory skills.Self-motivated team player, and capable technical contributor.Strong creative, trouble-shooting and analytical capabilities.Able to work well in a multi-disciplinary team environment.Excellent verbal and written communication skills.Able to effectively prepare and present technical data and reports.
Experience in the design, analysis, and development of medical devicespreferred.Work LocationNY - Rochester-1400 N Goodman StreetRelocation Available YesStatus Full-Time*****************************************************
Contact Robin directly if interested in this position. 760-597-1700 x106,Robin
Clinical Resource Group760-597-1700 [email protected]
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SR. GCP Auditor
The purpose of this position is to lead/participate in GCP Audits to assurethat all aspects of clinical studies conducted have been executed incompliance with applicable FDA, ICH GCP Guidelines and other governmentand/or country specific regulations.
In addition, actively participate in sustaining a level of inspectionreadiness of Clinical Groups, to include core membership of the RegulatoryInspection Team.
Assist in the identification of internal GCP quality issues, and be acatalyst for process improvements and partner with Clinical Operations topromotion of best practices.
Actively participate in Clinical Compliance team meetings, and otherconsultative meetings as necessary, to keep track of issues, activities andimplementation of decisions, as well as provide procedural information andupdates as needed.
Company is great! The Sr. manager is someone who would bea wonderful person to work for. As I mentioned, current travel about 50% toEurope, S.America and Asia but the ultimate goal is to have a team of threeor more so no one is doing more than 25% travel. Must be based out of SFarea office. Company will relocate the right person. Salary 120K+. The needis immediate so please have anyone that may want to know more contact medirectly.
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Matt Talmadge, SF Bay Area Medical Consultant Quality, Regulatory, and Clinical Affairs APT Medical Consulting (253) 853-3707x102 _www.aptmedical.com_ (http://www.aptmedical.com/)
Sr. Regulatory Specialist: Job Title: Sr. Associate, Regulatory Affairs (south-bay) SUMMARY: The Sr. Regulatory Associate will be responsible for the compilation and submission of regulatory documents to the FDA and other regulatory agencies to support active INDs/CTAs/NDAs. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
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• Prepare and submit monthly amendments, new protocols, and adhoc amendments. • Review regulatory documents for submission of new investigators packages to ensure compliance to regulations. • Catalog, archive, and maintain regulatory communications with regulatory agencies • Lead preparation of Annual Reports and Investigator Brochures. • Manage special regulatory projects with supervision. • Support preparation of responses to queries from regulatory authorities, coordinate reproduction of submission copies and submission of responses. • Perform overall quality review of regulatory submissions and ensure information is accurate and complete. • Establish processes and write departmental guidelines (e.g., archiving regulatory documents, submitting amendments to Canada and US regulatory authorities, preparation of Annual Reports) ***************************************************** This is Andrew Youngelson, Healthcare Technology Recruitment Partner fromKey Recruit, Inc. Andrew YoungelsonKey Recruit Inc.www.keyrecruit.com
Thanks in advance for passing the opportunity along.
Please Indicate by job ID which you are interested in!
Associate Director of Clinical Research, Pharmaceutical**
Date Posted: 10/21/2008 Job Id: 1660 Company: We are an eye care company. We are committed to makingvision perfect and improving the lives of consumers around the world. Weoffer the world's most complete collection of eye care products. Ourhealthcare brand is one of the best known and most valued worldwide. Ourproducts are available in more than 100 countries. We continue to invent newmaterials, engineer new technologies, and create ground-breaking ways tohelp people see better. Location: Upstate New York Reports To: Director of Clinical Research Salary: 120-180K Bonus 15%
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Education: OD or MD. (Ophthalmic focus) Requirements: 5-7 years research or related experience. Must haveexcellent communication, organizational and writing skills. Special Skills:Experience with ophthalmic pharmaceuticals for the treatment of glaucoma anddry eye preferred. Demonstrated ability to train study personnel and studyCRAs. Ability to manage multiple projects simultaneously. SpecializedTraining: Experience/training in GCP, ICH and/or FDA pharmaceuticalregulations is beneficial. Minimum 3 years Phase IV experience. Clinicalglaucoma and/or dry eye experience. Duties: Participate on (pharmaceutical) R&D teams as clinicalrepresentative. Participate in development of clinical and commercialstrategies, including evaluation of new business opportunities. Coordinatewith project management and clinical operations to assure that clinicaltimelines are met. Present clinical results internally, in the professionalliterature and at professional conferences. Independently manage allscientific aspects of pharmaceutical clinical trials. Ensure compliance withFDA regulations, GCP and ICH guidelines. Develop field clinical protocols.Participate in Investigator recruitment. Identify and evaluate clinicalissues related to the project and implementation resolutions. Interpretclinical data and contribute to clinical reports. Provide input ondepartmental decisions related to process and procedures.
____________________________________
Principal Scientist, Toxicology **
Date Posted: 10/21/2008 Job Id: 1658 Location: Upstate New York Reports To: Director of Toxicology Salary: $92K- $115K Bonus 15% Education: Ph.D. in Toxicology or related field. Requirements: Minimum of 4 years experience in Medical Device Toxicology.Strong working knowledge of regulations and requirements for safetyassessment and experience in managing non-clinical safety studies. Duties: Overseeing the planning, strategy, development, and
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execution of the Non-clinical Safety programs supporting company, and otherareas as needed; prepare and defend regulatory documents; provide guidanceand risk assessments on new formulations, leachable/extractables, industrialhygiene, workplace safety, and environmental issues; and (iv) manage studiesat external contract facilities. Represent the Non-clinical Safety functionon project teams. Design strategies, execute and manage Non-clinical Safetyprograms focused on our products. Conduct risk assessments on keyingredients, impurities, and formulations. Publish novel investigativefindings in high-quality journals and present data at scientific nationalmeetings. Oversee and evaluate activities of contract research organizationsperforming toxicology studies.
____________________________________________Manager, Regulatory Affairs **
Date Posted: 10/21/2008 Job Id: 1659 Location: Upstate New York Reports To: VP Regulatory Affairs Salary: 78-100K Bonus 15% Education: BA/BS degree in a technical or scientific discipline.Advanced degree or additional professional training would be of value. Requirements: 5-7 years experience in Regulatory Affairs with ademonstrated capability and experience preparing submissions for US ClassII/Class III medical devices, as well as non-US medical device products. 10+years experience in the medical device or drug industry desired. Knowledgeof medical device or drug GMPs desired. Special Skills: Must have excellentcommunication, organization, and writing skills. Specialized Training:Computer literate with general office software and internet use. Duties: Provide Regulatory Affairs support to manage productdevelopment projects to include 510(k), PMA, IDE, label/advertising reviewand other Regulatory Affairs support activities. Prepare US and non-USproduct submissions such as 510(k), PMA, IDE, CE technical file. Thisrequires participation in product development teams as well as to review,analyze and comment on technical reports. Review, approve, and provideguidance for labeling and advertising of B&L device products. Counseltechnical and business groups to establish direction, based on availabledata and regulatory considerations. Provide review and guidance of failureInvestigations and corrective actions referred to Regulatory Affairs.
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Provide guidance on Regulatory compliance. Review and approve policies andprocedures. Interact with US and non-US government officials on productapproval and compliance issues. Provide input and comment to regulations andstandards which may affect our device products. _________________________________________Manager, Regulatory Affairs-Florida **
Date Posted: 10/21/2008 Job Id: 1661 Location: Florida - West Coast Reports To: VP Regulatory Affairs Salary: 78-100K Bonus 15% Education: BS/BA degree in technical or scientific discipline required.Advanced degree or additional professional training preferred. Requirements: 7 years experience in Regulatory Affairs (Pharma).Experience in preparing medical device submissions and food supplements aplus. Project management experience or similar experience within R&Dpreferred. Must have excellent communication, organization and writingskills. Strong influencing and negotiation skills. Commercial knowledge andunderstanding of business needs. Computer literate (MS) and internet use.Special Skills: Must be familiar with existing legislation and keepup-to-date on development and trends affecting product registrationworldwide. Specialized Training: Must be fluent in Spanish language. Duties: Responsible for Regulatory activities in Latin America.Communicate with the Commercial team, Global Strategy, and local countrymanagers. Work with the Global Regulatory Affairs group to develop workschedules to best meet regional and global demands. Act as the liaison withrelevant internal departments and licensing authorities to drive projects tosuccessful conclusion and to meet company-agreed goals. Work closely withCompany affiliates (Germany, France, UK, Canada) to coordinate projects.Provide timely resolution to issues raised by national health authorities.Respond to general regulatory queries. Ensure key personnel at ourorganization are kept informed of developments in a timely manner.
As always thanks for passing on!
Visit www.keyrecruit.com to view other openings.
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If Interested
You should upload you resume and send me a copy as a Word document And tellme your current salary, Include a cover letter explaining why you would be agood fit for this position using the using the keywords in the jobrequirements as a guide. Letter should include how your work in the past isrelative to client needs in the present. *****************************************************
Contact Danielle directly for full description of the opportunity.
Danielle Moua , Aerotek Inc. , ( Work: 408-367-6819 , Fax: 408-367-6890 , *E-mail: <mailto:[email protected]> [email protected]
Title: Process Engineer Location: Menlo Park, CA
Summary:
Responsible for process development related to a microstructure technologyfor delivering small and large molecular weight drugs through the skin.
Responsibilities/Duties:
* Develop process & equipment concepts and assist engineering teams inthe implementation of these concepts.* Write equipment specifications. Write and execute FAT, IQ, OQ and PQprotocols. Analyze data and identify conclusions. Write reports. Presentresults to the project team.* Plan and execute continuous process improvement for the pilot andsmall scale clinical manufacturing process and equipment.* Assist in the development of a pilot production unit utilizing newequipment and new facilities based upon the findings of the processdevelopment group.* Assist in the development and transfer of equipment design conceptsand processes for large scale manufacturing to an offsite location.* Design custom mechanical and electro-mechanical fixtures for thetesting and fabrication of the drug-delivery device.* Perform design verification testing and characterization of amechanical device using off-the-shelf and custom test equipment.
Qualification/Experience Requirements:
* BS or higher in mechanical or chemical engineering* >3 years experience in the development of medical or drug-device
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combination products* >3 years experience in process engineering including equipmentspecification, FAT, IQ, OQ and validation_________________________________________________________________________
Title: Quality Engineer / Senior Quality Engineer, Location: Fremont/Newark
Purpose of Job: Provide engineering support in the development and maintenance of company'squality systems.
Major Duties and Responsibilities:
* Coordinate the reporting, analysis, and resolution of materialnon-conformance incidences * Develop quality assurance specifications, test methods, samplingplans and related written procedures. * Coordinate the identification, assignment, monitoring, andcompletion of product improvement projects. * Assist Regulatory Affairs Department in preparation of regulatorysubmissions and interface with the FDA or other regulatory agencies in caseof on-site audits.
Education/Experience Requirements: BS in Mechanical Engineering, Chemical Engineering or MaterialScience/Engineering, or equivalent work experience in the therapeutic deviceindustry._____________________
Title: Quality Engineer , Location: Fremont/Newark
Implementation of quality systems, process controls and corrective actionsystems to meet Quality Management System requirements to ensure safe andeffective products are developed and produced. Identifies and implementsquality/process control systems to support the development, qualificationand ramp-up manufacturing of devices.
* Assist manufacturing engineering in the development, approval, andimplementation of design verification, design validation, and processvalidation protocols and reports.* Coordinate failure analysis of customer complaints with Engineeringto determine root cause and corrective/preventive action. * Plan and perform requested internal and supplier audits to ISO andFDA requirements.* Assist Engineering with the development of a Technical File tosupport CE Marking of product to MDD requirements.
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* Review document control changes to products, process, software andother changes for reliability/quality impact. * Identify non-conformance trends and lead the investigation to solvethe problem. Identify non-conforming trends, prepare Quality metricsperiodic reports and develop investigation plans if applicable. Review andapprove the disposition of non-conforming product.
Qualifications needed: . Working knowledge of federal regulations and ISO Standards regardingQuality System Regulations (21CFR820 QSR, ISO13485:2003, and MDD) . Demonstrated understanding and use of quality tools and continuousimprovement methods. Utilize standard statistical analysis and problemsolving techniques. . Must have experience in developing medical devices and transferring themto manufacturing including demonstrated knowledge of design verification,design validation, and process validation. . Strong verbal and written communication skills. . Exceptional attention to detail is critical. . Excellent interpersonal skills.
Requires a BS in Engineering with 5 years medical device experience. CQEpreferred.____________________________________________________________________Title: Quality Engineer , Location: Palo Alto, CA
Duties will include:
. Design, monitor, review and update Quality System Documentation(Manual, SOPs, Work Instructions, forms, etc)
. Participate in quality-related activities from productdevelopment, production/process controls through post-market service
. Identify and assist with implementation of preventative andcorrective actions via CAPA audit, NCMR, and complaint handling systems.Monitor and ensure assigned corrective actions are complete and effective.
. Key participant in inspections for FDS, ISO, MDD and otherregulatory agencies
. Prepare, monitor and report quality department performance to plan
. Participate in quality audit activities. Prepare and maintainsupplier quality audit schedules and coordinate supplier audits. Performproduction line audits
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. Establish and manage Incoming, In-process and Final inspectionacceptance systems
. Establish and maintain statistical technique utilization
. Perform quality review and approval for lot History Records tosupport Clinical and Commercial lot release
. Establish and manage a validation program; including equipment,facilities and process validation
. Evaluate new materials and establish incoming specifications tosupport new product development
. Manage biocompatibility testing and sterilization validation.Pro-actively participate in design controls, production/process controls,and other activities
. Manage the company calibration system
BA degree in Engineering or Life Sciences and a minimum of 5+ years ofdirect related experience with dual/combination medical devices._____________________________________________________________Title: QE Manager , Location: Sunnyvale, CA
Medical Device is seeking a dynamic Quality Manager to add to their team.
Summary of responsibilities : Implement, support, and sustain proceduresrequired to move clients products through the PDP process leading tocommercialization. Manage QEs who perform similar functions. Interact in across-functional manner with PDP teams, R&D, manufacturing, and BusinessUnits to ensure products meet requirements, have identified and managedrisks, and comply with the company Quality System.
Essential Duties and Responsibilities include but are not limited to:
* Ensures implementation and compliance of the Quality System to FDAQSRs, MDD, ISO 13485:2003 and other relevant international regulations. * Collaborate with engineering, manufacturing, and regulatory, andwork with outside labs and suppliers. * Ensure that compliance to cGMP and EN/ISO 13485:2003 /MDD/Canadianand other international regulations and standards are maintained. * Ensure that all the responsibilities within the scope of this jobcomply with the scope of the Quality System. * This position will manage Quality Engineers
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Qualifications:
* Requires a team player with a bachelor's degree in engineering orlife sciences and 4 to 10 years experience, or an AA and equivalent workexperience totaling more than 12 years in the medical device industry.Master's degree in Quality or Business preferred. * Minimum of 2 years management experience. * Requires the ability to understand the impact of GMP's, ISO13485:2003, Canadian, Japanese and other international standards, and MDDrequirements on company products
***************************************************** Hansle GuichardoStaffing ConsultantProtech Corporate Enterprises Inc.www.protechpharma.comQUALITY ASSURANCE - PHARMACEUTICALS AND BIOTECH Director, Quality Assurance, Long Island, NY Biotech experience is required. Advanced degree preferred. Hands on experience with the FDA and other regulatory agencies. Must be a QA Director or Assoc. Dir.
Director, Quality Assurance, Rhode Island (Brand name Company)Must have a PhD degree, no exceptions. API's experience is necessary. Hands on interaction with the FDA is a must. Must be a QA Director or Assoc. Dir.
Director, Quality Systems, TexasExperience with liquids and semi solids is required. Advanced degree preferred. Recent hands on QA/QC experience for at least 8 years and hands on interaction with the FDA and other regulatory agencies is required.
Manager, Quality Assurance, Southern CAMust be a QA Manager with experience in parenterals/sterile pharmaceuticals (not biologics or biotech). BS or MS degrees. Must have plant QA experience for at least 6+ years.
QC Biochemistry Manager, Central NJ0-2 years supervisory experience in a biochemistry lab. 4+ years of experience in a biotech company. QC hands on experience is required. BS or related.
Quality Systems Supervisor, NJExperience managing documentation systems and documentum is required. BS degree and pharmaceutical experience. Some supervisory experience is ideal.
Principal Quality Assurance Engineer, Utah
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Must be a QA engineer with experience analyzing quality issues in QA production and laboratories. Complaints, APR's, Investigations. BS in Engineering or related and 14-19 years experience in pharmaceuticals.
Sr. Quality Engineer, UtahAPR's, Investigations, complaints, deviations, compliance. BS in engineering or similar and 9-13 years experience in pharmaceuticals with 2 years of CAPA/deviations systems experience. Must be a QA engineer in order to be considered.
Sr. Quality Engineer, Southern CaliforniaAPR's, Investigations, complaints, deviations, compliance. BS in engineering or similar and 9-13 years experience in pharmaceuticals with 2 years of CAPA/deviations systems experience. Must be a QA engineer in order to be considered.
QC Chemist, Finished Product, 2nd Shift, New JerseyExperience testing finished dosage form in terms of semi solids and liquids is required. 2-4 years of QC pharmaceutical testing experience.
Quality Auditor, Clinical (GCP's), New JerseyExperience in conducting GCP audits of sponsored clinical trials, CROs, clinical laboratories and internal processes. 35% travel is required. BS degree and 3+ years of biotech experience is required. GCP, ICH, and FDA regulations.
QA Compliance Auditor, New JerseyEvaluate facilities/metrology non-conformances. investigations, deviations, compliance. BS degree with biotech experience is a must. 10% travel.
Compliance Specialist, New JerseyMust have hands on experience in providing GLP support to the Toxicology Lab and preclinical Toxicology studies; and for providing GMP support to Clinical Pharmacology and the QC Stability Group. BS and 3+5 years of experience in a biotech company in either QA or QC.
Product Disposition Specialist, New JerseyHands on experience in the Review and release commercial and clinical final products and review batch records and associated documents from contract manufacturers and packagers. BS and 3+5 years experience in a biotech company is a must. Quality systems and laboratory processes.
Microbiologist, New JerseyEntry level microbiologist position. BS degree and 1+ year of experience in pharmaceutical microbiology.
Metrologist, New JerseyCalibration, metrology SOP's, execution of validation protocols. AS degree and 1+ year of related experience in pharmaceuticals.
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Quality Systems Specialists, New JerseyQuality tools like process mapping, FMEA, Cause and Effect, Pareto analysis. Develops and maintains expertise in cGMP, QSR, TrackWise, iLearn@, QIS, Baan and other QS computer systems. BS and 2+ years of pharmaceutical QA experience.
Microbiologist Scientist, TexasHands on experience in a pharmaceutical microbiology lab is required. BS degree and 3+ years experience. Quality Engineer II, Southern CaliforniaInvestigations, product complaints, APR's. Experience monitoring and trending key areas and indicators from production and laboratories for implementation of corrective and preventative measures. BS degree and 3-5 years of QA engineering experience in a pharmaceutical company.
Quality Engineer II, UtahInvestigations, product complaints, APR's. Experience monitoring and trending key areas and indicators from production and laboratories for implementation of corrective and preventative measures. BS degree and 3-5 years of QA engineering experience in a pharmaceutical company.
LTS Scientist III, Southern CaliforniaHands on experience in method investigations, method validations, method transfers, and method comparisons. BS with 5-8 years experience in pharmaceuticals. UV/IR, HPLC, AA and GC instruments, dissolution testing, operation methods and techniques.
Sr. Quality Auditor, UtahReview and release raw, intermediate and finished materials and products, as well astheir corresponding batch records. Audit data from Quality Control, vendors' certificates of analysis. repare, revise and verify SOP, QSMS, IQ/OQ, Swab Data and clinical releases. BS and 3+ years of pharmaceutical QA auditing experience.
REGULATORY AFFAIRS - BIOTECH AND PHARMACEUTICALS
Director of Labeling, New Jersey - BiotechMust be a Director or Assoc. Dir.Hands on experience with all aspects of regulatory labeling requirements for the lifecycle of any given project and have familiarity with EU and other health authority labeling requirements and act as liaison to contract research organizations or partners for discussions concerning regulatory requirements. BS and 9-14 years of experience in a Biotech company. 5+ years of regulatory experience.
Manager, Regulatory Affairs, New Jersey - Generic solid dosageMust be a Manager of RA. supervision/preparation and critical review of high quality regulatory submissions to the FDA including ANDAs, amendments, supplements, and annual reports. Manages the regulatory associates in the preparation, compilation and submission of
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high quality ANDAs, amendments, supplements, annual reports, control documents, etc. to FDA authorities. BS degree and 7-10 years of RA experience in a pharmaceutical generic company.
RESEARCH & DEVELOPMENT - PHARMACEUTICALS
Director, Product Development, TexasMust be a Director or Assoc. Dir. in Product Development. Must have overall responsibility for the operation and management of the Formulation and Process Development groups. A strong understanding of topical formulations is required along with a firm understanding of the drug development process and associated regulatory guideline, specifically in prescription products but may also include OTC, DESI, and cosmetic products. PhD in Pharmaceutics, Engineering, or similar degree is required. Master's degree or equivalent may be considered with substantial experience and a proven record of achievement.
Principal Investigator, In Vitro Pharmacology, New JerseyFLIPR, GPCR, ion channels. Experience with either neuroscience or pain research. PhD in a related field and 56+ years experience is required. Must have In Vitro Pharmacology experience in a Discovery R&D Pharmaceutical lab.
Principal Investigator, Organic/Medicinal Chemistry, New JerseyExperience in the design and synthesis of compounds (individual or as part of libraries) in accordance with approved project protocols. PhD degree and 5+ years of hands on Pharmaceutical experience in Medicinal and Organic Chemistry is required.
Principal Scientist, AR&D, UtahExperience in the performance and overseing of the development and validation of methods for testing raw materials, drug substances and drug dosage forms. BS or MS or PhD in Science or related scientific field Eighteen (18) years related pharmaceutical laboratory experience. Hands on experience with method development, validation and transfers. Generic AR&D experience desired.
Sr. Associate Scientist, Organic/Medicinal Chemistry, New Jerseydesign and synthesis of compounds (individual or as part of libraries) in accordance with approved project protocols. BS or MS in Chemistry or related Science field and 6+ years of hands on Pharmaceutical experience.
Research Scientist, AR&D, New JerseyMethod Development and validation as well as writing validation protocols and reports. working knowledge of industry guidance, separation sciences, spectroscopy and a variety of hands-on analytical techniques, e.g. HPLC, Dissolution, Karl Fischer. PhD with only 2-4 years industry experience or MS with only 4-6 years industry experience.
Sr. Scientist, AR&D, UtahHands on method development, validation and transfers. BS or advanced degree and 9+ years of AR&D experience. Generic experience desired. IP, FP and ST sample testing such as
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HPLC, Gas Chromatography (GC), UV, automatic titrator, IR, AA and TLC and dissolution testing
Sr. Scientist, AR&D, Southern CaliforniaHands on method development, validation and transfers. BS or advanced degree and 9+ years of AR&D experience. Generic experience desired. IP, FP and ST sample testing such as HPLC, Gas Chromatography (GC), UV, automatic titrator, IR, AA and TLC and dissolution testing
Sr. Pharmacist, Product Development, Southern CaliforniaPharmaceutical formulation science and solid dosage form development, including stability and dissolution methods and techniques. Designing formulations and processes for pharmaceutical products; defining subsequent series of experiments based on the previous study plan results. BS and 9+ years of experience in a formulations lab. Generic solid dosage is desired.
R&D Technical Writer, TexasResponsible for the writing, issuing and maintenance of all written documentation issued by R&D for the reporting of R&D and R&D related activities. BS degree and 3+ years of technical writing experience.
Sr. Scientist, Product Development, TexasFormulate and develop products - with an emphasis on oral, nasal, and topical/skin care formulations for contract customers. The products would include semi-solid and liquid dosage forms such as creams, lotions, ointments, gels, suspensions, solutions and aerosols. PhD and 0-2 years, MS and 1-4 or BS 5+ years formulation experience.
Research Scientist, Formulations, Maryland (only local candidates)Responsible for developing pharmaceutical dosage forms and preparing those products for subsequent scale-up in a multi-disciplinary team setting. BS/BA required, MS/MA preferred. Experience in Semi solids and liquids Formulation Development.
Sr. Analytical Chemist, Northern Californiause of HPLC, LC/MS, NMR, GC/MS, DSC/TGA, various FT-IR techniques in determining foreign substance identity, amongst other analytical techniques. PhD or MS or BS in organic synthesis and / or related analytical work. Candidate must have development, validations, and transfers of analytical methods as well as direct experience in small organic molecules structure elucidation in the pharmaceutical industry
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