Senior Associate Scientist, Cell Banking

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Posted
Feb 19, 2021
Closes
Feb 27, 2021
Ref
536088
Jobseeker Type
Professional
Organization Type
Corporate
Hours
Full Time
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As a Sr. Associate Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be part of Pfizer's Bioprocess Research & Development, Cell Banking team that is responsible for the manufacturing and testing of GMP cell banks used to produce clinical and commercial biopharmaceutical products. You will be responsible for performing cell bank testing oversight activities, including identifying required tests, working with contract testing laboratories to manage testing submissions and providing technical review and interpretation of results. You will also contribute to regulatory submissions by authoring cell bank-related content and performing data verification activities.

With your deep knowledge in the discipline, you will be an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.

It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Coordinate cell bank testing, including creation of specifications, submission of samples to testing laboratory and review and approval of results.
  • Maintain all related data and records in compliance with cGMPs and quality procedures.
  • Collaborate with team members and partner functions (e.g. Quality and Regulatory) to ensure all cell bank testing-related Quality and Compliance requirements are met.
  • Support product investigations and new method evaluation(s) as needed.
  • Contribute to achievement of goals and influence at the project team level.
  • Author content for regulatory filings and queries.
  • Pay attention to detail, strictly adhere to standard operating procedures, and use knowledge of cell banking and regulatory requirements to advance projects under rapidly shifting priorities and timelines.


Qualifications

Must-Have
  • Bachelor's Degree in Biology or related scientific discipline with 2-4 years of relevant experience OR Master's Degree in Biology or related scientific disciple with 0-2 years of relevant experience.
  • Experience with cell culture and bioprocessing technology.
  • Working knowledge of cGMP (current Good Manufacturing Practices).
  • Experience authoring technical documents.
  • Working knowledge of Quality and Regulatory requirements for biotherapeutic products.
  • Organized, self-motivated, and capable of working independently or in a collaborative environment.
  • Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
  • Excellent written and oral communication skills.


Nice-to-Have
  • Experience with cell banking activities (manufacturing, storage, testing).
  • Significant knowledge and practical application of microbiological/viral testing methods and molecular based techniques.
  • Experience authoring content for Regulatory Filings.
  • Experience representing functional area on project teams.


PHYSICAL/MENTAL REQUIREMENTS
  • Position requires occasional light lifting and periods of standing, sitting or walking.


Other Job Details:
  • Last Date to Apply for Job: February 25, 2021
  • Eligible for Employee Referral Bonus: YES


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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.

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