Regeneron is currently looking for a Principal External Manufacturing (EM) Specialist to join the Advanced Therapies External Manufacturing Team that specializes in synthetic chemistry-based manufacturing. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This role oversees all aspects of contract manufacturing organizations and partners including day-to-day operations, ensuring timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance.
As a Principal External Manufacturing Specialist, a typical day might include the following:
Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities.
Coordination of 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 material, 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.
Functioning as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
Leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
Supporting investigations which concern external manufacturing and associated shipping operations, as required.
Supporting and informing strategic initiatives and contract negotiations that drive long-term relationship stability and success.
Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners.
Support tech transfer and/or development work of programs at a CMO to ensure scalability toward GMP manufacturing.
Performing reviews of pre-production master batch records and executed batch records.
This role might be for you if:
You have experience in any of the following areas: small molecule synthetic chemistry and/or siRNA therapy.
You have knowledge of bulk manufacturing techniques (recommended) - chemical synthesis, downstream purification, annealing, lyophilization.
You have basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations.
You lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.
You have strong interpersonal, written, and oral communication skills.
You exhibit a degree of ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.
You can gain understanding from provided instructions and work towards goals with minimal supervision.
Can travel to contract manufacturers or business partners, as required (up to 25%).
Are comfortable with leading a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
Shows resiliency and flexibility in the face of challenge and adverse situations.
To be considered for the Principal External Manufacturing Specialist you must be willing and able to work Monday- Friday, 8am-4:30pm and be willing to travel. You must have a BS/BA in business or scientific discipline and 8+ years of related experience; or equivalent combination of education & experience. cGMP experience is preferred in either in manufacturing operations (clinical and/or commercial) or supplier management. Level is determined based on qualifications relevant to the role.
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
