Cmc Statistics Jobs in Alabama (NOW HIRING)

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Material Sciences Engineer to join our Drug Product Process Sciences team. This is a technical services department that deals with a range of scientific, technical, technical, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. In this partially lab-based role you will focus on material science and provide technical support to manufacturing, quality, combination products, formulations, and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

When & where:

• Location: East Greenbush, New York, United States
• Work model: Monday-Friday, 8am-4:30pm
• Travel percentage: 5% domestic & occasionally international

Discover your role:

• Applies materials expertise across polymer science, physics, metallurgy, ceramics, and composites, connecting structure, processing, properties, and performance to drive design, development, and life-cycle management in biomedical or biopharmaceutical environments
• Provides technical support, guidance, and risk assessment related to materials science across technology transfer, design transfer, process control strategy, process validation lifecycle, and post-commercialization activities
• Analyzes data and information-from development through late-stage characterization and at-scale manufacturing history-using statistics, engineering principles, and other techniques to drive insights into process performance and control
• Applies engineering principles to develop and execute process controls and validation strategies, including support for laboratory and at-scale studies for process characterization and validation
• Liaises with cross-functional departments (Combination Products, Manufacturing, Quality Control, Formulation Development, Advanced Therapies, Quality Assurance, and CMC Regulatory) to support process lifecycle management
• Authors protocols, reports, and technical documents with conclusions grounded in process and product knowledge, and ensures SOPs, policies, and validation plans align with industry/regulatory expectations (e.g., ICH guidelines)
• Supports audits/inspections and contributes to CMC sections of regulatory submissions as needed

This role requires:

• BS in Materials Science Engineering or related Engineering field and 8+ years of relevant experience
• M.S. or Ph.D. preferred
• A background in aseptic processing, drug substance development, drug product development, combination product development

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)