Sr. Manager, Co-Development Team Leader
Location: Saint Louis
Posted on: April 8, 2021
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,
- Responsible for CMC strategy development, execution, and CMC
- Deliver to the clinical supply plan for pivotal / Phase 3
- Communicate and align with key stakeholders, including
escalation of major changes and issues, project risks and
- 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
- Flexible and adaptable to changing priorities and timelines
(acceleration/deceleration), meeting deadlines, and working well
- Able to plan and organize workload; demonstrated success in
working independently and managing multiple products in
- Effective written and verbal communication skills; able to work
with different cultures. PREFERRED QUALIFICATIONS
- Experience with technical transfer of biological / vaccine
- Experience with co-development process for new biological /
- 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
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.
Keywords: Pfizer, St. Louis , Sr. Manager, Co-Development Team Leader, Hospitality & Tourism , Saint Louis, Missouri
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