Job DetailsWe are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers. As a Principal External Manufacturing Specialist, a typical day may include the following:
- Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities.
- Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
- Ensure the timely routing and review of all master manufacturing records (MRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at contractors and/or business partners.
- Coordinate all DP 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, track and monitor cycletimes, and providing any required associated reports and technical expertise.
- Travel to contract manufacturers or business partners, as required.
- Provide regulatory filing supports (IND, BLA, MAA, etc.).
- Maintain required training status on Regeneron specific work instructions and SOPs.
- Lead a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
- Support all investigations which concern DP Manufacturing or associated shipping operations, when required.
- Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
- Travel up to 50% (domestic and international).
This role may be for you if:
- You have knowledge of external manufacturing from formulation through the final package.
- You have knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- You are proficient in Excel, PowerPoint, Visio, Word, Oracle etc. in addition to experience working within shared work environments.
- You exhibit strong interpersonal, written, and oral communication skills.
- You demonstrate confidence, has a high emotional IQ, and has strong interpersonal, written, and oral communication skills for providing team updates.
- You are able to impart understanding of provided instructions, develop instructions and sets and works towards goals with minimal supervision.
- You show a degree of ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.
- You illustrate resiliency and flexibility in the face of challenges and adversarial situations.
- You understand and listen to team members and stakeholders needs while supporting productive team environments toward a common objective.
To be considered for the role you must hold a minimum of a BA/BS in any physical or biological science with 8+ years industry relevant experience, 7+ years with MS or 2+ years with PhD.Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.Salary Range (annually)$89,100.00 - $145,500.00