Senior Product Technical Lead
Job Description
Use Your Power for Purpose
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.
What You Will Achieve
The Site Technical Services Group (STS) is seeking a highly motivated individual as a Senior Product Technical Lead. The ideal candidate will have hands on, and strong leadership experience with large scale biopharmaceutical processes/equipment principles and practices. A strong regulatory compliance and Good Manufacturing Practice mindset/experience is required and who can work independently.
As a Senior Product Technical Lead, your advanced knowledge of the principles and concepts in the Product Lifecycle Management and comprehensive knowledge of other areas will enable you to lead complex projects at the site level. Your ability to develop and manage projects will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve project goals.
It is your dedication that will make it possible for customers and patients to receive the medicines they need, when they need them.
How You Will Achieve It
In this role, you will:
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.
Here Is What You Need (Minimum 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.
Bonus Points If You Have (Preferred Requirements)
- 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.
PHYSICAL/MENTAL REQUIREMENTS
Perform complex data analysis for process analysis, troubleshooting or process improvement. Thought leader regarding process robustness/process capability.
Able-bodied; must be able to climb flights of stairs and be standing for ~1-2 hours at a time.
Inspiring – Motivate and develop self and others to drive the business forward.
Courage – Consistently demonstrate accountability and integrity.
Resilience – Respond to change with agility, optimism, and innovation.
Decisive – Manage complexity to make timely informed decisions.
Focus – Develop impactful short- and long-term solutions for our customers and patients.
Connected – collaborate with others to accomplish shared goals.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Standard M-F work week
None/little travel
Occasional off-shift requirements
Work Location Assignment: Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
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.
EEO & Employment Eligibility
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. This position requires permanent work authorization in the United States.
Company Information
Location: New York, NY
Type: Hybrid