Job Description
We are seeking a new Senior Manager to help lead Operations & External Development (OED) within Chemical Research and Development (CRD) in Groton, CT, USA. The successful candidate will partner with the Process Chemistry & Technology (PCT) and CRD Management Teams to guide portfolio and operational deliverables, primarily through building and enhancing effective external development partnerships. CRD, as part of Pharmaceutical Sciences Small Molecule (PSSM) within Pfizer Research & Development (PRD), is responsible for the development of process technology for production of Active Pharmaceutical Ingredient (API). CRD leaders engage in all facets of development from small scale synthesis in support of early clinical assessment, to development of robust API processes for commercial scale manufacture. CRD leaders partner with manufacturing specialists in kilo-lab and pilot plant facilities, as well as provide oversight for technology transfer to Pfizer manufacturing sites and third-party facilities. The successful candidate will guide one or more diverse teams of scientists primarily at Chemical Research & Manufacturing Organizations (CDMOs), ensuring clear accountability for, and oversight of, laboratory activities focused on route and process design following the CRD API development workflows. The OED Sr Manager will ensure effective process understanding and transfer of commercial processes to our Pfizer Global Supply (PGS) partners, with accountability for advancement of programs through the API Development Workflows. They will ensure effective resource allocation, portfolio prioritization, development strategy, regulatory documentation, safety, and compliance in the delivery of robust and high-quality processes for APIs through CDMOs. They will ensure effective tracking of, and feedback on, CDMO performance to demonstrate business value and successful progression of projects. They will bring strong knowledge and expertise in Quality by Design and control strategy, including a strong and contemporary working knowledge of ICH guidelines. They will be a proven leader, ensuring effective performance, engagement, and continuous improvement of external development partners. They will be an active member of the PCT Management Team to partner with Engineering, Global External Supply and CRD Manufacturing to ensure smooth operation of the department. They will be accountable for building, communicating and adhering to annual budget targets for externalized API development. The OED Sr Manager serves as a CRD Accountable Manager, assuring overall portfolio progression through effective resource application, with a primary focus on progression of small molecule development assets utilizing a preferred network of CDMOs.
Role Responsibilities
Critical Thinking
- Sets goals, objectives, and priorities for the delivery of our portfolio, ensuring effective route and process design to support clinical development, regulatory submission and new product launch. Serves as CRD Accountable Manager to ensure one or more projects progress to agreed milestones, with a primary focus on supporting external development.
- Provides technical and functional expertise within CRD, ensuring sound process chemistry and Green Chemistry principles are applied to the portfolio, in alignment with ICH guidelines.
- Leverages technical and functional expertise from PSSM, Medicine Design and PGS to ensure effective development of commercial routes and processes.
- Considered a subject matter expert in process chemistry, process engineering or analytical research & development.
- Takes appropriate business risks to achieve desired results, ensuring safety and project delivery at all stages of development. Guides Pfizer and CDMO scientists regarding acceptable levels of risk-taking.
- Develops solutions to optimize the balance of speed, cost, and quality, integrating CRD technology advances such as computational chemistry, robotics & automation, continuous processing, biocatalysis, chemical synthesis innovation and high throughput screening in the advancement of clinical drug candidates.
- Ensures effective technical transfer of commercial processes to PGS, including accountability for regulatory submissions, knowledge management, adherence to regulatory guidance and support of regulatory queries.
- Generates realistic and balanced forecasts for near, mid, and long-term resource needs, and effectively constructs and operationalizes portfolio budgets to ensure efficient, effective advancement of endorsed projects.
Leadership
- Collaborates across PSSM, Medicinal Design and PGS to deliver a cohesive strategy for portfolio delivery through effective use of external resources.
- Is a CRD Accountable Manager for one or more portfolio programs, ensuring effective portfolio delivery and efficient execution viaa blend of internal and external (CDMO) staff.
- Manages scientific resources for one or more external development projects, ensuring strong integration of chemistry, analytical and engineering expertise. Adjusts project team size and construct to deliver results while ensuring budgetary targets are met.
- Uses knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the effective delivery of the portfolio via external development partnerships.
- Develops and exhibits a high level of business knowledge and understanding of CRD Manufacturing and PGS to meet customer requirements for development and manufacturing of small molecule APIs.
- 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.
Communication
- Actively shares knowledge across CRD, PSSM, Medicine Design and PGS to ensure effective design and execution.
- Actively engages with industry peers in pre-competitive space to develop and enhance global best practices.
- Ensures strategic decisions on projects are supported by the CRD Leadership Team (LT).
- Contributes to the evolution of workflow and best practice with strong collaboration across Co-Development and with clear communication of risks and mitigation strategies to the Portfolio Delivery Team (PDT). Contributes to a communication-rich environment to ensure the knowledge and expertise of the entire team is leveraged.
- Contributes to the continuous improvement of external API Development Workflows and processes to enhance Co-Development, and regulatory and technical success.
Qualifications
Required Education/Experience
- PhD Chemist, Analyst or Chemical Engineer with a minimum of 10 years relevant pharmaceutical research & development experience in small molecule API
- BSc/MSc Chemist, Analyst or Chemical Engineer with a minimum of 15 years relevant pharmaceutical process research & development experience in small molecule API.
Required Technical Skills
- Recognized as a strong scientific leader within the API process development community. Is acknowledged as an expert in the pharmaceutical development process.
- Contemporary awareness of significant scientific developments and opportunities in chemistry, analytics and/or chemical engineering.
- A highly credible technical functional expert with experience in mentoring others. Able to leverage technical and functional expertise across own and related disciplines. Innovative and creative approach to problem solving (both business & scientific), with ability to impact and influence within the global line and outside of the department.
- Ability to lead in a rapidly changing environment & communicate positive advantages of change. Early adopter of new technologies/ways of working to enhance business productivity.
- Possesses significant API manufacturing, commercialization, Technology Transfer and Regulatory Dossier authorship and/or review experience.
- Experience working on large, complex, cross-disciplinary matrix teams.
Preferred Technical Skills
- Expertise in pharmaceutical process development, continuous process development and manufacturing, computational chemistry, biocatalysis and/or high throughput experimentation.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, oversee and guide the work of others, and create positive business impact.
PHYSICAL/MENTAL REQUIREMENTS
- Ability to perform complex tasks with appropriate mental agility, including mathematical calculations and complex data analysis. High change agility.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Will be required to occasionally travel domestically and internationally (5-10%) to support establishment and optimization of CDMO relationships, project team objectives and Co-Development business processes, including API manufacturing campaign preparations.
Work Location Assignment: On Premise at an active Pfizer site, with relocation assistance available
The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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. This position requires permanent work authorization in the United States.
Research and Development
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