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Pfizer Quality Control Senior Scientist, Product Lead in Andover, Massachusetts

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

  • 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.

BASIC QUALIFICATIONS

  • 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.

PREFERRED QUALIFICATIONS

  • LC-MS experience is desirable.

  • ELISA experience is desirable.

  • Experience with Continuous Improvement tools desired.

PHYSICAL/MENTAL REQUIREMENTS

  • 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

  • #LI-PFE

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Quality Assurance and Control

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