Sr. Manager, Co-Development Team Leader

Company: Pfizer
Location: Saint Louis
Posted on: April 8, 2021

Job Description:

United States - Missouri - St. Louis - Chesterfield United States - North Carolina - Sanford The Co-Development Team Leader role leads a cross site and cross functional product focused team(s) and is responsible for CMC strategy development and execution as well as overall CMC budget of late stage clinical product development (Co-Development). The Co-Development Team Leader provides technical leadership for large molecule (biological, vaccine) projects, to help deliver the biologics portfolio, which includes various technologies and modality platforms. For each product assigned, the candidate will be responsible for short term and long-term strategies, scenario planning, and achieving major milestones, including development, manufacturing and regulatory submission content. The candidate will build relationships with business line partners (Business Units, Global Product Development (GPD), Pfizer Global Supply (PGS) functions and manufacturing sites, and Biotherapeutics Pharm Sciences (BTxPS)) to advocate for the strategies, plans and timelines of Co-Development Team(s). ROLE RESPONSIBILITIES

• Represent CMC (PGS and BTxPS) at the Global Medicine Team (GMT) - led by GPD and Pfizer Biopharma Group (PBG).
• Lead cross-functional matrix Co-Development Teams working closely with BTxPS, manufacturing sites, GMTs, Vx Program Teams, and Business Units, to evaluate technology and processes to transfer, validate, and submit CMC regulatory modules to health authorities, gain marketing approval, and launch new vaccine and large molecule products and/or support post approval major product enhancements of marketed products (i.e. new devices / formulations, line extensions).
• Responsible for CMC strategy development, execution, and CMC budget.
• Deliver to the clinical supply plan for pivotal / Phase 3 studies.
• Communicate and align with key stakeholders, including escalation of major changes and issues, project risks and opportunities.
• Drive decision making in environment of competing priorities and varying levels of ambiguity.
• Create highly empowered and cohesive team(s) that can rally behind a compelling vision. BASIC QUALIFICATIONS
  • BS degree in bio / chemical engineering, biochemistry, biology or other science related field.
  • 9 years in production, engineering or process development (depending on degree).
  • Demonstrated ability to effectively lead matrix teams; ensuring successful completion of major programs / projects as part of a team and/or project leadership role.
  • Demonstrated ability to interact effectively with colleagues at all levels of the organization, including senior internal and/or external personnel on matters often requiring coordination between organizations; able to build effective relationships and influence stakeholders at all levels of the organization.
  • Able to develop solutions to complex problems using ingenuity, innovation, creativity, and leadership skills.
  • Extensive technical and industry-specific expertise in biologics development and/or manufacturing.
  • Understanding of process of developing biologic drugs and CMC requirements.
  • Flexible and adaptable to changing priorities and timelines (acceleration/deceleration), meeting deadlines, and working well under pressure.
  • Able to plan and organize workload; demonstrated success in working independently and managing multiple products in parallel.
  • Effective written and verbal communication skills; able to work with different cultures. PREFERRED QUALIFICATIONS
    • Experience with technical transfer of biological / vaccine products.
    • Experience with co-development process for new biological / vaccine products.
    • Experience with Pfizer budget processes, including managing project budgets (expense spending and FTEs).
    • Understanding of Business Development processes. Last date to apply for job: April 16, 2021 Eligible Employee Referral Program
      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. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 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. 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. Engineering#LI-PFE Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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