Senior Product Scientist/Engineer 2
Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them.
What You Will Achieve
The Andover Site Technical Services Group (ASTS) is seeking a highly motivated individual for a Principal Process Scientist/Engineer. The ideal candidate will have hands on strong leadership experience with large scale biopharmaceutical processes/equipment principles and practices. A strong regulatory compliance and Good Manufacturing Practice mindset/experience is highly required and who can work independently.
The role encompasses the ongoing lifecycle process/product management of commercial and near-commercial biopharmaceuticals drug substances compounds including development and implementation of regulatory post approval process changes. The individual will be expected to provide detailed technical leadership, process understanding and expertise in support of processes within all manufacturing suites at the Andover, MA manufacturing site including both mammalian and/or bacterial processes. A track record of solving complex technical, regulatory, compliance and operational issues through collaboration with stakeholders and other scientists, engineers, operations, and quality control/quality assurance groups. Familiarity with Lean/Six-Sigma methodologies are desirable.
How You Will Achieve It
- Ownership of the lifecycle management of two or more biopharmaceutical commercial products
- Collation, analysis and communication of process performance for the purpose of educating staff and developing ideas for process improvement/robustness.
- Lead/participant in cross functional teams in the evaluation, regulatory assessments, and implementation of process improvements, process changes and new manufacturing technologies.
- Provide technical process expertise in evaluation of process and regulatory trends/requirements and subsequent implementation of associated changes.
- Provide technical process expertise in determination of root cause of process excursions and drive implementation of corrective actions.
- Assist in planning for and management of production campaigns.
- Assess changes to raw materials and their impact on the process (s)
- Lead/support projects for operational/process robustness across multiple products and manufacturing suites.
- Be responsible for or assist with regulatory filings and regulatory query responses under critical timelines.
- Be the technical lead in representing a process/product during internal audits and board of health inspections
- Represent Andover site at co-development teams for new product introduction and launch planning; represent Andover site at network product technical teams on product lifecycle planning and E2E technical issue resolution.
- Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associate degree with 8 years of experience OR a bachelor's with at least 5 years of experience OR Master's Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
- Relevant pharmaceutical experience
- Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations.
- Demonstrated leadership, management, and technical capabilities.
- Ability to interpret and communicate complex technical and process information/issues concisely to facilitate decision making.
- Self-motivated and able to drive multiple assignments simultaneously.
- Proven project management, analytical, problem-solving skills.
- Strong written and verbal communication skills.
- 10+ years of relevant experience
- Master's degree
- Strong Leadership skills
- Broad knowledge and/or experience in biologics product lifecycle management, global regulatory requirements, biopharmaceutical production logistics, and product launch logistics
- 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
- Flexible work schedule
- Standard M-F work week, 1st shift.
- None/little travel required.
- Occasional off-shift requirements
Work Location Assignment: Flexible
OTHER JOB DETAILS
- Last Date to Apply for Job: November 10, 2023
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: YES
Relocation assistance may be available based on business needs and/or eligibility.
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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.