Pfizer Quality Control Senior Scientist, Product Lead in Andover, Massachusetts
The qualified candidate will be product lead for analytical support for biological products in quality control analytical (QCA) Technical Support group. The candidate will write regulatory filings, review and approve technical documents, provide ongoing analytical support to the lab and manufacturing, and lead an analytical task force. The work also includes performing method qualifications/validation/verification activities, method improvements, and troubleshooting analytical methods.
Andover biological Analytical product lead (product point of contact). Oversight and management of analytical product Lifecycle for Site's responsibilities. Collaborate with site functional areas and customers to support site goals and objectives. Participate in Corporate Network forum from an analytical perspective. Write regulatory filings and respond to various board of health questions.
Technical Support of protein products; provide scientific advice in support of investigations/troubleshooting for analytical issues in the QC laboratory as well as manufacturing.
Support characterization of protein products and reference materials
Identify technical issues, method performance, instrument malfunctions and look for CI opportunities/method improvements. Implement new analytical technologies.
Drive and manage method validations, method transfers, investigation, and analytical studies.
Support Change controls and instrument validation.
Meet all timelines and deliverables in support of Andover protein product manufacturing.
Bachelor's Degree in chemistry, biochemistry or related discipline with 10 years of relevant experience, OR Master's Degree with 8 years of relevant experience OR PhD with 2 years of relevant experience experience required.
Extensive knowledge and practical application of relevant analytical techniques (analytical testing and troubleshooting) required.
Extensive knowledge and experience with protein analysis, HPLC/UPLC, peptide mapping, CE/gel and UV required.
Demonstrated leadership skills in decision making, planning and prioritization. Focused on team success to meet defined metrics and timelines.
Knowledge of cGMP, audits, industry standards and ICH, and applicable validation regulations is required.
Strong troubleshooting skills and technical writing skills.
Strong oral and written communication skills .
Candidate must be self-motivating and be able to adapt to rapidly changing project priorities.
LC-MS experience is desirable.
ELISA experience is desirable.
Experience with Continuous Improvement tools desired.
- Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.
Other Job Details:
Last Date to Apply for Job: 03 DECEMBER 2020
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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