We are currently looking to fill a Principal External Manufacturing Specialist. The Principal External Manufacturing Specialist oversees all aspects of external manufacturing contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance. Additionally, the Principal Specialist provides guidance to other specialists as well as consults with management on all contract manufacturing operations and GMP compliance issues.
In this role, a typical day might include the following:
Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
Coordinates external manufacturing activities at contract and/or business partner sites, including but not limited to: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide any required associated reports and technical expertise.
Coordinates/oversees multiple external manufacturing activities at multiple sites, as required.
Coordinates/oversees DS and FDS manufacturing at CMO as dictated by project.
Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners.
Leads sub-teams in continuous process improvements, system/equipment implementation and/or strategy development.
Leads or supports all investigations which concern external manufacturing and associated shipping operations.
Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.
Performs reviews of pre-production master batch records and executed batch records.
Authors documents and procedures.
Supports audit operations, both internal and external.
Analyzes data for trends and potential issues.
Travels 25% (target) or more (domestic and international), as required.
This role might be for you if:
Knowledge of external manufacturing from formulation through the final package.
Knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
Proficient in Excel, PowerPoint, Visio, Word, Oracle etc. in addition to experience working within shared work environments.
Strong interpersonal, written and oral communication skills.
Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
Ability to impart understanding of provided instructions, develop instructions and sets and works towards goals with minimal supervision.
Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
Shows resiliency and flexibility in the face of challenges and adversarial situations.
Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
Competent in German and/or French (oral and written) is a plus.
To be considered for the Principal External Manufacturing Specialist, you must have a BS/BA in a scientific discipline and 8 years of related experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing), including experience collaborating with CMOs/CROs, or equivalent combination of education and experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
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)
$92,200.00 - $150,600.00
