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    Sr Manager, Crd Operations And External Development

    Pfizer
    15+ years
    Not Disclosed
    Ringaskiddy
    10 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/PhD/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    This job description outlines the role of a Senior Manager, Operations & External Development (OED) within Chemical Research and Development (CRD) at Pfizer, based in Groton, CT, USA. The role involves overseeing and enhancing external development partnerships, focusing on the development of robust Active Pharmaceutical Ingredients (API) processes, and collaborating with Contract Development and Manufacturing Organizations (CDMOs).

    Key Responsibilities:

    1. Portfolio Management and Strategy:

      • Lead portfolio deliverables through effective route and process design, supporting clinical development, regulatory submissions, and product launches.
      • Ensure successful progression of projects by managing external development teams and overseeing portfolio milestones.
      • Integrate technical and functional expertise to optimize processes and commercial routes.

    2. External Development Partnerships:

      • Manage collaborations with CDMOs, ensuring the smooth transfer of processes and technology to Pfizer Global Supply (PGS) and third-party facilities.
      • Ensure adherence to regulatory guidelines, including participation in regulatory submissions and addressing regulatory queries.
      • Track and evaluate CDMO performance, ensuring business value and successful project outcomes.

    3. Leadership and Team Management:

      • Guide cross-functional teams within Pfizer and external development partners, ensuring efficient resource allocation and team integration.
      • Drive the development and implementation of strategies, processes, and innovative solutions (e.g., computational chemistry, automation) to accelerate drug development.

    4. Risk Management and Decision Making:

      • Assess and manage project risks, balancing speed, cost, and quality to deliver successful outcomes.
      • Provide strategic guidance to CDMOs and Pfizer scientists on acceptable levels of risk and process adjustments.

    5. Budget and Resource Management:

      • Develop and manage realistic resource forecasts and portfolio budgets.
      • Ensure the efficient application of resources to meet portfolio objectives.

    6. Communication and Collaboration:

      • Act as a liaison between internal teams and external partners, ensuring smooth communication and alignment on project goals.
      • Share knowledge and best practices across Pfizer teams and the industry, fostering a collaborative environment.
      • Contribute to the continuous improvement of external development workflows and processes.

    Qualifications:

    Required:

    • PhD in Chemistry, Chemical Engineering, or a related field with at least 10 years of experience in small molecule API development, or a BSc/MSc with 15 years of experience.
    • Expertise in pharmaceutical process development, API manufacturing, commercialization, and technology transfer.
    • In-depth knowledge of ICH guidelines and regulatory processes.
    • Proven leadership skills, with experience in mentoring and leading cross-disciplinary teams.
    • Experience managing large, complex projects, including budget management and resource forecasting.

    Preferred:

    • Expertise in continuous process development, computational chemistry, biocatalysis, or high throughput experimentation.
    • Strong background in Green Chemistry and process optimization techniques.
    • Familiarity with regulatory dossier preparation and reviews.

    Physical and Mental Requirements:

    • Ability to perform complex tasks and data analysis with mental agility and adaptability to changes.
    • High change agility in a fast-paced environment.

    Travel and Work Schedule:

    • Occasional domestic and international travel (5-10%) for CDMO relationship management and project optimization.
    • The position is on-premise at a Pfizer active site, with relocation assistance available.

    Additional Information:

    • Applicants for roles in Ireland must have legal work eligibility in the country, but no relocation support is provided for positions based in Ireland.

    Company Culture:

    Pfizer is committed to creating an inclusive, diverse, and equitable workforce. The company values courage, joy, equity, and excellence and fosters a culture that encourages continuous learning and innovation. Pfizer also emphasizes its commitment to disability inclusion and provides reasonable accommodations to support diverse applicants.

    How to Apply:

    Candidates interested in this opportunity should apply with their CV. This is an exciting opportunity to lead and innovate within a dynamic, global organization committed to transforming patient outcomes.

    This position is ideal for an experienced leader in pharmaceutical development who excels in managing external partnerships and advancing complex API development projects.

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