Skip to content
Senior Product Technical Lead
| Company | Pfizer |
|---|
| Location | Andover, MA, USA |
|---|
| Salary | $112700 – $187800 |
|---|
| Type | Full-Time |
|---|
| Degrees | Bachelor’s |
|---|
| Experience Level | Senior |
|---|
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.
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.
Preferred Qualifications
- Experience in problem-solving, negotiations, presentation and working in a matrix based multi-layered organization, including comprehensive understanding of DMAIC (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.
