Senior Product Technical Lead

About the position

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need when they need them. By collaborating with our innovative engineering team, you will help accelerate the delivery of medicines to the world by envisioning new possibilities and taking decisive action. Your role is vital in making sure that the production processes are efficient and reliable, ultimately contributing to the well-being of patients globally. Join us in our mission to bring essential medicines to those in need, faster and more effectively than ever before.

Responsibilities

• Provide technical stewardship, and support on process troubleshooting, process improvements, process & product changes, investigations, and quality risk management associated with products manufactured or licensed in Pfizer Global Supply Andover.
• Serve as the site primary interface for network-level technical governances and teams including, but not limited to, product technology teams, co-development teams, Pharmaceutical R&D project teams.
• Lead site-based cross-functional technical team in developing, maintaining, and implementing site-centric product technical strategy and lifecycle plan necessary to support site product supply plan, performance target/commitment, regulatory/compliance obligations, and end-to-end product lifecycle plan from the Pfizer network.
• Participate in site-based product teams to develop product strategy and deliver site product commitment (safety, quality, supply, and financials).
• Provide technical leadership to maintain, remediate, and improve process robustness/manufacturability, product supply assurance, and knowledge management.
• Responsible for the maintenance of process validated state along with the associated continued process verification, quality risk assessments, and annual product reviews.
• Lead and/or support regulatory submissions associated with process changes, second generation process introduction, investigations, and board of health commitments for licensed products and products undergoing registration.
• Serve on/support cross-product process performance and modernization matrix team to establish, apply, improve, and modernize uniform process control strategy essential for process consistency, process robustness, and optimal process performance.
• Provide guidance, and support to junior staff supporting other product lifecycle activities.

Requirements

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Relevant pharmaceutical experience.
• Effective written and verbal communication skills.
• Strong interpersonal skills and experience working in a team environment across business functions and matrix organizations.
• Independent, self-motivated, and flexible with the ability to work effectively in a dynamic, problem-solving environment.
• Strong mammalian or microbial process expertise.

Nice-to-haves

• Experience in problem-solving, negotiations, presentation and working in a matrix based multi-layered organization, including comprehensive understanding of DAMIC (six sigma) tools and practices and a focus on continuous improvement.
• Broad knowledge of technology transfer process and manufacturing for biopharmaceuticals drug substances compounds.
• Strong technical understanding of pharmaceutical processes and the impact of technical change.
• Demonstrated experience and competence in organizing, planning and problem solving related to biopharmaceuticals drug substances compounds.
• Demonstrated experience on regulatory submission strategy, audit responses and technical discussion with board of health.

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.