External Manufacturing Specialist

Rensselaer, NY, United States
Feb 11, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill an External Manufacturing Specialist position. This position is responsible for all aspects of contract manufacturing operations including day-to-day operations, ensure timely completion of associated operations/documentation and assist in the monitoring of cGMP compliance at drug product contract manufacturers.

In this role, a typical day might include the following:
• Serving as a Regeneron operational contact for select contract manufacturing sites concerning day-to-day activities
• Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and external partners
• Coordinating manufacturing activities at contract and/or business partner manufacturing sites, including but not limited to: scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site, supervise and monitor cycle times, and enlisting support from others who will provide any required associated reports and technical expertise
• Leading sub-teams in continuous process improvements, system/equipment implementation and/or strategy development
• Supporting all investigations which concern manufacturing or associated shipping operations, when required
• Ensuring product integrity and company reputation
• Reviewing of executed batch records and pre-production master batch records

This role may be for you if you:
• Have knowledge of drug product manufacturing from formulation through the final package
• Possess basic knowledge of regulatory compliance including cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
• Exhibit confidence, have a high emotional IQ, and have strong interpersonal, written and oral communication skills for providing team updates
• Like collaborating with external vendors and partners
• Enjoy travel to contract manufacturers or business partners up to 25%

To be considered for this role you must hold a Bachelor's degree in scientific subject area with 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products) for Associate Specialist level, 2+ years for Specialist level and 5+ years for Sr Specialist level. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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.