Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Target Resume Now
About the Role
Regeneron is seeking a Principal External Manufacturing Specialist to oversee contract manufacturing organizations and partners, ensuring operational efficiency, documentation completion, and cGMP compliance for synthetic chemistry-based oligonucleotide manufacturing.
Responsibilities
- Serve as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities.
- Coordinate external manufacturing activities at contract and/or business partner sites, including scheduling batches, supplying materials, providing shipment direction, tracking cycle times, and supporting manufacturing activities.
- Act as a liaison between Regeneron departments (Quality Control, Quality Assurance, Supply Chain, Operations/Logistics) and external manufacturers or partners.
- Lead a sub-team in continuous process improvements, system/equipment implementation, and strategy development.
- Support investigations related to external manufacturing and shipping operations.
- Inform strategic initiatives and contract negotiations to ensure long-term relationship stability.
- Monitor cGMP compliance at contract manufacturers and business partners to ensure product integrity and company reputation.
- Support tech transfer and development work at CMOs to ensure scalability for GMP manufacturing.
- Perform reviews of pre-production master batch records and executed batch records.
Requirements
- BS/BA in a scientific discipline and 8+ years of experience in cGMP manufacturing operations, or equivalent combination of education and experience.
- Experience in small molecule synthetic chemistry and/or siRNA therapy is recommended.
- Knowledge of bulk manufacturing techniques (chemical synthesis, downstream purification, annealing, lyophilization) is recommended.
- Basic knowledge of regulatory compliance including cGMP, FDA regulations, ICH guidelines, and EU regulations.
- Ability to lead continuous improvements, system implementations, and strategy development to reduce cycle times and improve efficiencies.
- Strong interpersonal, written, and oral communication skills.
Skills
- cGMP manufacturing operations
- Small molecule synthetic chemistry
- siRNA therapy
- Bulk manufacturing techniques
- Chemical synthesis
- Downstream purification
- Annealing
- Lyophilization
- Regulatory compliance
- cGMP
- FDA regulations
- ICH guidelines
- EU regulations
- Continuous improvement
- System implementation
- Strategy development
- Interpersonal skills
- Written communication skills
- Oral communication skills
Location
- East Greenbush, New York, United States
Work Type
- On-site
- Monday-Friday, 8am-4:30pm
Experience Level
- 8+ years
Education Level
- BS/BA in a scientific discipline
Salary/Compensations
- $92,200.00 - $150,600.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- We believe we do our best work when we are together.
Equal Opportunity
- 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.