Lead Investigator
Pfizer, Inc.
St, MO
The Lead Investigator is a position within the Chesterfield Manufacturing Facility (CMF) organization. This position is responsible for completing investigations and related CAPAs in support of GMP manufacturing. The CMF is responsible for manufacture of DNA plasmid starting material derived from microbial culture processes, and polyconjugate vaccines for use in clinical trials. This position will be a part of the CMF Operations Support team.
ROLE RESPONSIBILITIES
• Author manufacturing investigations within the CMF quality system.
• Coordination of all manufacturing investigations within the CMF quality system to ensure timely completion.
• Lead routine meetings with CMF Operations and Quality to discuss status of open investigations.
• Author and Change Controls for CMF Operations.
• Manage investigation timelines against product dispositions.
• Support audits as needed.
• Support other CMF documentation needs as needed on a non-routine basis (CAS assessments, audit responses, validation, etc.).
• Communicate appropriately on activities and progress to management and key stakeholders.
• Take personal responsibility for own work, pushing self and others to exceed goals and deliver results.
BASIC QUALIFICATIONS
• BS/BA or MS in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent
• 4+ (BS/BA) or 2+ (MS) years of experience in a cGMP Clinical or Commercial Manufacturing setting with in-depth expertise of common biotechnology processes including mammalian cell culture or microbial fermentation and associated purification steps
• Proven ability to troubleshoot complex processing / product quality issues and ability to make decisions with minimal guidance required
• Advanced technical writing skills
• Proficient in Microsoft Word
• Ability to self-manage timelines and deliverables
• Good communication skills, both verbal and written
• Advanced interview skills
PREFERRED QUALIFICATIONS
• Experience with Production Control Systems (i.e. DeltaV), QTS and other business systems (Document Management Systems, LIMS , etc.)
• Prior experience writing cGMP manufacturing investigations
• Prior experience with corporate or regulatory audits
• Demonstrated capability to assemble a matrix cross-functional team
PHYSICAL/MENTAL REQUIREMENTS
Ability to work in a clean room environment.
Work Location Assignment: On Premise
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.
