Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
In this role, you will provide technical leadership and strategic input in the fields of analytical science, product development, regulatory strategy and all other aspects of commercial product lifecycle management for Pfizer Global Supply (PGS) Bios commercial products. You will work closely with BTx Pharm Sci and Vaccines Research Leadership teams to actively influence all aspects of technology selection and development to support new bios candidates and ensure alignment with PGS manufacturing strategy, capability and future plans. As the Analytical Technology Lead, you will lead a team of scientists.
How You Will Achieve It
- Provide technical leadership and partner with network leadership teams across Analytical Technology/GT&E, Quality and PGS to set strategic plans to guide future technology initiatives and to meet technical support needs for all aspects of commercial product manufacture and lifecycle management.
- Responsible for talent development, providing direct line management and scientific leadership to multi-disciplinary team of scientists based at Andover, MA (USA).
- Provide strategic input to guide late-stage co-development programs and the associated regulatory strategies.
- Work closely with Pharm Sci and Vaccines Research Leadership Teams to guide future test and characterization technology strategy applications for future bios products.
- Lead technology transfer activities and development of submission packages for accelerated and Lightspeed programs as required.
- Drive continuous improvement initiatives to lead implementation of new technologies to improve operational robustness, efficiency, and performance.
- Partner closely with the Quality Operations Leadership team on key analytical network projects to support product compliance and lifecycle improvement initiatives.
- Provision of technical subject matter team expertise to network Quality, Regulatory and site operation groups during: complex laboratory and manufacturing investigations, tech transfers and new process introductions and regulatory submissions.
- Representation of GT&E/Pfizer at various inter-company project meetings, project meetings with third party partners, global regulatory and scientific industry meetings.
- Participation with the Site EHS and other senior members of the Analytical Technology team to remain in conformance with Health & Safety and Environmental regulations, to ensure that all staff members work safely.
Qualifications
Must-Have
- Bachelor's Degree in a technical/life sciences discipline.
- 12+ years of experience in the biopharmaceutical industry supporting new product development, technology transfer and manufacturing.
- Outstanding leader behaviors and the ability to collaborate with and mentor others is a must.
- Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
- Proficient with the use of a variety of problem-solving, risk analysis and statistical tools.
- Highly proficient in Regulatory dossier strategy and CMC response development.
- Highly experienced with all aspects of the Quality/GMP/ICH/compliance systems of the biopharmaceutical industry.
- Education and technical expertise in the majority of fields of: analytical chemistry, protein biochemistry, cell- and immunology-based bioassays and technology transfer.
Nice-to-Have
- Advanced degree preferred.
- Experience in progressing late-stage biologics through Process qualification and Regulatory submissions.
- Knowledge of analytical life-cycle management in manufacturing environments.
- Change agile, functional in a fast-paced team environment where multi-tasking required.
Non-Standard Work Schedule, Travel, or Environment Requirements
- Domestic and International travel (less than 15%)
- Adaptation of schedule to work across different time zones as required
Other Job Details
- Last Day to Apply: 30 May 2023
- Work Location: Andover, MA
Relocation assistance may be available based on business needs and/or eligibility.
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.
Research and Development
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