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 the Method Transfer Lead in Pharmaceutical Sciences Small Molecule (PSSM) Analytical Research and Development (ARD), you will play an important role during all phases of pharmaceutical development. This colleague will take an active role by leading drug substance and drug product method validations and transfers. You will work with cross-functional development teams and validate and transfer a variety of methodologies to contract manufacturing organizations (CMOs) and Pfizer Global Supply (PGS) enabling the seamless delivery of the portfolio. Additionally, you will serve as a departmental resource and subject matter expert in relevant procedures and compliance for related GMP (Good Manufacturing Practice) activities. This includes PSSM ARD technical oversight and implementation for the redesign of the Pfizer Quality System (PQS), PGS Project Revolution, with focus on the future state of ARD Policies & Procedures.
How You Will Achieve It
- This colleague will be responsible for leading the efforts to centralize drug substance and drug product method validations and subsequent analytical method transfer exercises (AMTEs)
- Interacting with vendors and commercial manufacturing partners to drive efficient technology transfers, including review of data as appropriate.
- Establish/mentor a centralized group within ARD to perform stage appropriate method validations.
- Collaborating with project leads to assess the most appropriate approach to method transfers, troubleshoot observations during transfer, and meeting established project milestones.
- Providing technical support on the mapping of the GMP data review process to incorporate seamless interfaces and digital solutions for data review.
- Serve as a subject matter expert in procedural and compliance requirements around validation and method transfer.
- Technical oversight of ARD focused Pfizer Quality Standards future state fit-for-purpose framework improving speed, quality & efficiency.
- Support data integrity efforts as needed, including detection of potential gaps and partnership with laboratory personnel for remediation efforts for analytical testing.
- The candidate must be able to collaborate with and mentor peers as well as effectively interact with colleagues at all levels of the organization.
- Preparing technical reports, critically reviewing data.
- Proficient with a breadth of relevant methodologies such as chromatography, dissolution, Infrared (IR) spectroscopy, mass spectrometry, particle size analysis and NMR, with expertise in one or more of these techniques.
Qualifications
Must-Have
- Ph.D. in Analytical Chemistry, Organic Chemistry or related field, with 20+ years of relevant industrial experience, or relevant pharmaceutical development experience.
- Demonstrated ability to meet timelines with minimal supervision and actively collaborate with multi-disciplinary teams.
- Extensive experience with analytical method validation and transfers.
- Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills.
- Demonstrated oral and written communication skills, including visualization of data and drafting reports.
- Demonstrated ability to learn new techniques and solve complex analytical problems.
- Experience with a wide variety of software and information systems.
Nice-to-Have
- Extensive experience with authoring, reviewing, and updating of pharmaceutical Standard Operating Procedures
- Experience in aspects of data integrity and implementation with respect to analytical methodology.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Additional Information:
- Relocation support available
- Work Location Assignment:On Premise
- Last Day to Apply: February 9, 2024
The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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