Pfizer Director, Drug Product Lead, Seasonal mRNA Vaccines in New York, New York
Why Patients Need You
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Pfizer Global Supply (PGS) is at the heart of fulfilling Pfizer's purpose as we work to make sure customers and patients have the medicines they need, when they need them.
What You Will Achieve
As the Director, Drug Product Lead seasonal mRNA Vx for Vaccines in Biotech and Sterile Injectable Technology, you will be accountable for the seasonal mRNA Vx Drug Product (DP) processes lifecycle and leading the matrix DP teams for Pfizer's seasonal mRNA vaccine assets (Ex: mRNA Flu). This scope includes leading the DP process development and transfers related to seasonal strain changes as well as new seasonal vaccines launches. Additionally, you will establish and lead PGS DP technical teams for each marketed seasonal vaccine asset and work with other functional leads to develop and implement DP lifecycle plans for each asset to meet supply needs. Examples of lifecycle projects and post approval change, include, but are not limited to: process evaluation and development related to strain changes, process robustness and second generation projects, support for complex investigations, process transfers, seasonal and post approval changes in DP process changes, changes in key components and raw materials.
As a Director, you will provide matrix leadership for other DP process team leaders in the seasonal RNA vaccine space. As the Drug Product Lead, you will build and maintain strong matrix relationships with key partners in GTE, Supply Chain, Manufacturing Sites, Launch Excellence, PGS Sites, Biotherapeutics Pharm Sci, Quality, Procurement, and Regulatory CMC.
How You Will Achieve It
Matrix leadership of DP teams and delivery of seasonal mRNA Vx DP CMC objectives in a fast-paced technical setting with stringent timelines
Serves as Technical expert of the unique aspects of mRNA DP process technology
In close collaboration with gCMC and other partner functions, prepare relevant Chemistry Manufacturing & Controls (CMC) sections of regulatory filings and queries.
Development of new process technologies in the mRNA post approval lifecycle that deliver improved cycle time, manufacturing productivity, robustness, and efficiency.
DP support for mRNA vaccines related complex investigations
Technical risk assessments and scientific support for qualifications of new raw material and component sources
Bachelor's Degree in a scientific/technical discipline of the life sciences such as biochemistry, biology, or similar
10+ years of experience in scientific / technical project management roles within the biotech industry, supporting DP process development, validations and transfers.
Technical expert of the unique aspects of mRNA technology, familiarity with technology and science related to drug product analytical assays.
Demonstrated track record of excellent matrix leadership skills and delivery of aseptic DP process technology objectives in a fast-paced technical setting with stringent timelines.
Proven ability to synthesize significant volumes of complex information and data into clear priorities and a focus on what is truly important for achieving project or program success.
Comfortable in an extremely dynamic environment with agility to change course quickly as new data and insights emerge.
Advanced project management skill sets in scoping, financials, and schedule development with a track record of best practices applied in a biopharmaceutical environment.
Significant experience leading multi-disciplinary direct and matrix teams to successful outcomes well supported by metrics.
Previous experience in taking major process changes through to the regulatory filing stage for marketed biologics / vaccine products as a post approval change.
Hands-on familiarity with drug regulations/regulatory processes and quality/GMP/compliance systems of the pharmaceutical industry. Direct experience interacting with the regulatory authoritieseither through meetings at the agencies, through regulatory filings reviews, through production site-inspections or other similar circumstances.
Demonstrated record of success in leading matrix teams of technical staff
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.
Requires the ability to process highly complex information and data quickly and under pressure. Large portion of deliverables are urgent and under timeline pressure.
- Advanced degree preferred
Non-Standard Work Schedule, Travel, or Environment Requirement
Travel up to 40%; ability to travel regularly in support of the labs and teams in their remit
Adaptation of work schedule to accommodate meetings with colleagues in different time zones
Other Job Details
Last Day to Apply: 09 June 2023
Work Location Assignment:Remote
Relocation assistance may be available based on business needs and/or eligibility.
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