Pfizer Senior Manager Downstream Process Development in Andover, Massachusetts
Manufacturing Sciences and Technology (MSAT) at Pfizer is looking for a highly motivated, versatile candidate to join our multidisciplinary team of scientists and engineers in Andover, MA. The group supports Pfizer's portfolio of late stage development and commercial biopharmaceuticals and vaccines, and is responsible for process troubleshooting, process improvements and second generation process development. We are looking for someone who is eager to contribute independent thinking, technical leadership and guidance, to lead a team of Downstream Purification Scientists. The ideal candidate should have a solid understanding and experience with all downstream/purification operations for bioprocess macro-molecules such as antibodies, cytokines and large polysaccharides. The candidate must be able to lead the design, execution and interpretation of complex studies requiring highly organized data collection and management.
As the team supports multiple manufacturing teams in complex troubleshooting activities, it is expected that the candidate be a proficient user of problem-solving and risk analysis tools, and have a strong understanding of regulatory environment impacted by change or deviations. It is highly desirable that the candidate is a routine practitioner of the Lean/Six Sigma and Continuous Improvement suite of tools including DMAIC, VSM, SIPOC, Visual Management, 5S etc.
As part of MSAT Andover Leadership team, with responsibilities for Downstream Purification, you will oversee scientific team members and ensure that the scientific / technical outputs are suitable for intended use in a cGMP manufacturing environment
Provide Technical Management and Leadership to the purification scientists
Lead the team in creation and execution of complex experimental designs, and oversee interpretation of large data sets, including multifactorial experimental design
Contribute to integrated resource planning tools (facility, equipment, personnel) for periods of 12 m (tactical) to 2-5 years (strategic planning).
Ensure a Continuous Improvement Mindset is embedded into team
Maintain the depth and scientific capability of the Downstream Team. Promote and drive the technical and personal development of team.
Collaborate with GCMC in preparation of relevant CMC sections for regulatory filing.
Ensure the group work safely at all times. Stay current with, and apply, all good work safety practices as recommended by the Andover site, the Biopharma Operating unit, and the company.
"Candidate 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."
PhD with 10+ years, or MS with 15+ years of experience in scientific / technical roles within the biotech industry supporting the development and commercialization of therapeutic recombinant proteins or vaccines, experience in biosimilar development highly desirable
Previous experience in designing and executing components of major experimental programs for biologics drug substance production in the laboratory or pilot-plant setting. Will have graduated over time to oversight of the execution of similar experimental programs by groups under his/her direct supervision.
Proficient user of problem-solving, risk analysis and statistical tools
Practitioner of the six sigma and Continuous Improvement suite of tools including DMAIC, VSM, SIPOC, Visual Management, 5S etc.
Highly proficient in common purification tools with considerable experience in associated transfer and scale up
Experienced in use of Design of Experiment (DoE) methodology and associated software (JMP, MiniTab) and other statistical tools
Hands-on familiarity with drug regulations/regulatory processes and quality/GMP/compliance systems of the pharmaceutical industry. Direct experience interacting with the regulatory authorities either through meetings at the agencies, through regulatory filings reviews, through production site-inspections or other similar circumstances.
Demonstrated record of success in leading teams and of direct supervision of scientific staff with varying levels of education and experience (BS, MS and PhD)
Consultative, open and transparent leadership style, with a self-assured bias towards decision making and action when circumstances demand.
Gains satisfaction from leading, mentoring and influencing the development and progress of others.
Highly motivated with a drive towards technical achievements of self and team.
Excellent communication skills (verbal + written).
Ability to matrix-work effortlessly across team and organizational / hierarchical boundaries
Will require significant data analysis, authoring and reviewing complex technical and regulatory documents and likely some review and/or authoring of batch records and SOPs for use in a cGMP environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require some out of hours working to support laboratory work or participation in teleconferences with other global sites.
Some travel may be required, but is not expected to be a standard aspect of role (
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Last Date to Apply for Job: 12.23.2019
Eligible for Employee Referral Bonus
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Research and Development