Associate Manager - Process Sciences MFG Support (Cell Culture)

Job Description

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.
Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.
Summary: You will lead a team to manage all activities to ensure that manufacturing processes are supported. Responsible to support the Process Sciences Department through Process Validation, manufacturing floor support, product impact assessments, investigations, and technical evaluation as required. Active member of the Process Sciences management team.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Lead a team and manage all activities to assure that manufacturing processes are supported.
• Responsible for developing a team such as development plans, upskilling and team forming.
• Write, review and approve Process Validation protocols and reports.
• Identification of process parameters and appropriate ranges to be included in process validation.
• Provide on the floor support to Manufacturing (Cell culture and Purification)
• Lead/Participate Process and Quality risk assessments.
• Lead troubleshooting activities associated with the manufacturing process.
• Provide technical support for manufacturing personnel to improve understanding of both cell culture and purification operations.
• Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
• Develops/writes/plans and reviews protocols and activities for manufacturing support.
• Serves as a subject matter expert (SME) for data trending and manufacturing support.
• Presents and reviews process monitoring data to IOPS Management as necessary.
• Investigates and reviews OOS and OOL IPCs investigations.
• Performs, reviews and approves product impact assessment.
• Performs, reviews and approves scientific investigations (EOE & DNF).
• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
• Support the site through regulatory audits by providing technical expertise.
Work efficiently and effectively in a fast-paced team-oriented environment to ensure maximum and high-quality output.
Education and Experience:
• BS/BA in a related field with 6+ years of related experience in a GMP environment. Previous experience in biological drug substance (DS) manufacturing.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.