Senior Scientist/Product Lead, Biologics

ROLE SUMMARY

Pfizer is seeking a talented individual to join our Quality Control Analytical (QCA) team in Andover, MA. As an experienced member of the QCA team, you will provide day-to-day leadership throughout the life cycle of biotherapeutic products. If you possess strong leadership skills, extensive knowledge and practical experience regarding relevant analytical techniques, this role may be for you.

ROLE RESPONSIBILITIES

As the Product Lead, you will oversee and coordinate all aspects of analytical activities during the lifecycles of biologic products. This includes being a point of contact for analytical support of products and processes, writing regulatory filings and responding to queries, authoring and reviewing technical documents, providing ongoing analytical support to the lab and manufacturing, and leading analytical activities. Additional responsibilities include:

• Driving and managing qualifications / validations / verifications, method transfers, and comparability studies
• Identifying technical issues and monitoring the methods of products
• Providing scientific advice for investigations / root cause analysis and resolution regarding analytical issues
• Overseeing and managing method improvement, new technology implementation and lifecycle activities
• Providing audit support for Board of Health inspections and regulatory responses
• Managing critical reagents and reference materials
• Supporting change control, instrument validation, and commitments
• Supporting continued process verification (CPV) of the products
• Meeting all timelines and deliverables in support of Andover protein product manufacturing
• Supporting continuous improvement opportunities and projects

BASIC QUALIFICATIONS

• Bachelor's Degree in chemistry, biochemistry or a 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
• Extensive knowledge and experience with protein analysis techniques, including HPLC/UPLC, peptide mapping, CE/gel, ICE and UV
• In-depth understanding of protein characterization and basic production processes
• Leadership skills in decision making, planning and prioritization
• Knowledge of industry standards and ICH, and applicable validation regulations
• Strong communication and technical writing skills
• Ability to work independently and to adapt to changing project priorities

PREFERRED QUALIFICATIONS

• cGMP and auditing experience
• Experience in bioanalytical methods, i.e. ELISA
• Experience with Continuous Improvement tools

  
 

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.

Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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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