Sr. Manager- Downstream Sciences

Regeneron Pharmaceuticals

254d • $106,400 - $203,000

About The Position

Regeneron is currently looking for a Sr. Manager to join our Process Sciences Downstream Sciences and Investigations (DSIG) team. The Sr. Manager- Process Sciences leads a team responsible for the assessment of changes to raw materials and their impact to Manufacturing & product and oversight of the product stability characterization to enable process validation. This position also maintains awareness of industry and regulatory trends to manufacturing technologies and material sciences to assess and support implementation within IOPS to remain in the forefront of industry.

Requirements

• Hold a B.S in Engineering, Chemistry or Life Sciences; M.S or PhD is preferred.
• Leadership/supervisory experience is required.
• For Manager Process Sciences: 7+ years of related experience.
• For Sr. Manager Process Sciences: 8+ years of related experience.
• Or equivalent combination of education and experience.

Nice To Haves

• Previous leadership experience including leading a team to meet team goals, performance evaluation/feedback, and mentorship.
• Previous operational & scientific experience related to the biopharmaceutical industry.
• Continuously seek to improve processes for improved performance.

Responsibilities

• Leads cross-functional teams in generating and analyzing data to assess raw material attributes for impact to new and existing manufacturing processes which include change notifications, secondary sourcing, raw material investigations, and impurity/byproduct/extractable risk assessments.
• Perform risk assessments for changes to raw materials to determine potential impact to the processes.
• Leads projects by developing appropriate plans, schedules, resource projections and other project deliverables.
• Coordinates studies and technical justifications, which may include authoring protocols, completing study protocols, and writing summary reports of results.
• Provide technical and scientific oversight to engineers and scientists to ensure accuracy and relevance of experiments or data analysis.
• Build systems and structures by which to manage and prioritize work against business drivers and various departmental needs.
• Coordinates prioritization of activities with area management.
• Set goals and performance targets to guide individuals and functions to achieve greater success.
• Reviews and approves study protocols and summary reports generated by the process sciences staff against established procedures.
• Leads team of process scientists and engineers who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Approves various documents relating to area function, including those listed above.
• Provide direction and assign work to personnel to meet goals and timings.
• Responsible for compliance monitoring of area operations, including lab and documentation activities.
• Participates in regulatory and customer activities including audits and GMP inspections.
• Collaborates with functional departments to resolve issues.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off for eligible employees at all levels

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree