Tech Transfer Sr. Manager

Pfizer • Sanford, NC

1d • Onsite

About The Position

Manage World Class Technical Staff equipped to provide technical leadership toward the Technical Transfer of new products as related to vaccines or MAB’s for the Sanford site. Directs and manages vaccine or MAB’s clinical team to support new technology transfers, process/cleaning validation projects, risk assessments, change control activities, process engineering projects and investigations support. Manages colleagues and consultants in the completion of projects. Develops validation master plans and determines acceptance criteria. Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Pfizer Values & global regulatory guidelines (including cGMP), environmental guidelines, as appropriate, etc.

Requirements

• Bachelor's degree in chemistry, biochemistry, biotechnology, chemical engineering or equivalent science related field or engineering and at least 6 years of experience OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience.
• 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.
• Permanent work authorization in the United States.

Nice To Haves

• A minimum of 2 years experience in the Sanford NC Technical Operations organization

Responsibilities

• Lead processing and feasibility discussions with R&D or other sending unit (VRU, Pharm Sci, Center Source) related to the Sanford site’s capabilities, present or future, toward tech transfer of potential new products.
• Technical leadership toward early feasibility discussions, evaluations, and proposals transitioning into formal Tech Transfer up through manufacturing of Phase 1, 2, 3 material up to BLA submission and PAI support.
• Provide leadership for technical evaluations of potential new products including influencing R&D process development to align with Sanford’s capabilities and site’s goals.
• Early interactions have the objective to improve alignment and platform processes for potential new processes with current site capabilities toward facility fit.
• Partner with the New Products Group business function to provide technical leadership and support related to requirements for successful Tech Transfer for new or potential new products into the site or across the site throughout the Tech Transfer lifecycle.
• Support NPG PMs toward campaign readiness including drafting new batch records, BOMs, block flow diagrams, etc. with input from other support groups such as manufacturing, engineering, R&D, as needed.
• Partner with engineering to provide processing leadership and oversite toward new or upgraded equipment or utilities with goal of successful process implementation due to the needed upgrades or changes.
• Provide verified data of campaign results in a compliant and usable form.
• Provide leadership and input for process related issues for new products and, as needed, existing products including investigation support, input for risk assessments, and other technical evaluations.
• Identify and resolve any operating issues that exist with the equipment during execution of operational qualification protocols in order to ensure flexible, efficient, and compliant use of the equipment.
• Analyze and interpret any equipment operational results in collaboration with cross-functional staff.
• Utilize detailed understanding of processes, equipment, facility, and distributed control system and cGMP requirements in order to write SOPs for functional area and general procedures.
• Facilitate review, approval, and implementation of these new SOPs.
• Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to manufacturing.
• Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities.
• Review company and site-specific SOPs, policies, and procedures and develop processes that meet the quality requirements set forth in these documents.

Benefits

• 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
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior