Process Controls & Validation Scientist

BioSpace; Town of East Greenbush (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron is seeking a Process Controls and Validation Scientist to support manufacturing, quality and CMC regulatory activities for ATMP processes from tech transfer to post-commercial lifecycle management. Located in East Greenbush, NY, with 10% travel and a Monday–Friday 8:00–4:30 schedule, onsite collaboration across departments.

The role involves risk assessment, data analysis, protocol authoring, regulatory alignment, and audits support.

Qualifications

• Background in aseptic processing or drug substance/product development preferred.
• Experience with AAV, siRNA, peptides or synthetic chemistry processes preferred.
• Level determined by experience: Scientist or Sr. Scientist.

Responsibilities

• Evaluate product and process risks during technology transfer and validation lifecycle.
• Analyze data from development through late-stage characterization and scale-up.
• Liaise with Manufacturing, Quality Control, QA and CMC regulatory.
• Author protocols, reports, and technical documents with data-driven conclusions.
• Ensure SOPs and validation plans align with regulatory expectations (ICH).
• Support audits/inspections and drafting CMC sections for regulatory submissions.
• Apply engineering principles to develop process controls and validation strategies.

Skills

Aseptic processing

AAV experience

siRNA experience

Synthetic chemistry

Education

Bachelor's degree in Chemistry/Biochemistry/Engineering or related field

Job description

Build Our Future Together

We are looking for a Process Controls and Validation Scientist to provide technical support to manufacturing, quality and CMC Regulatory (Chemistry, Manufacturing and Controls) for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities. Process Sciences is a technical services department that supports a range of scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. This position focuses specifically on support of a variety of Advanced Therapy Medicinal Products (ATMPs) and includes collaborating with contract manufacturing organizations.

When & Where

Location: East Greenbush, NY, United States

Shift: Monday- Friday- 8-4:30pm

Travel: 10% travel domestic, sometimes international

Discover Your Role

• Evaluate product and process risks during technology transfer, design transfer, process control strategy development, LMP, process validation lifecycle and/or post-commercialization activities
• Analyze information and data from development through late stage-characterization as well as at-scale manufacturing history
• Liaise with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle
• Author protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge
• Ensure alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines
• Provide support to audits/inspections and drafting of CMC sections of regulatory submission as needed
• Apply engineering principles to the development and execution of process controls and validation strategies

This Role Requires

• Bachelors degree in Chemistry, Biochemistry, Engineering, or a related fieldScientist: BS/BA in Sciences with 2+ years proven experience
• Sr. Scientist: BS/BA in Sciences with 5+ years proven experience
• The level of this position will be determined based on your experience and qualifications
• A background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation is preferred
• Experience involving AAV (Adeno-Associated Virus), siRNA (small interfering RNA), peptides and/or synthetic chemistry processes is preferred

Does this sound like you? 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.

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)

$67,400.00 - $128,700.00

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.