Principal Engineer (Drug Product)

We are currently looking to fill a Principal Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer position. The Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer supports and/or leads equipment selection, CMO selection strategy, management of equipment qualification and/or process validation activities and will be hands-on solving issues during technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The Engineer also provides floor support during operations of internal or external manufacturing, reviews process data to ensure operational consistency after processes are successfully transferred and provides support for investigations.

In this role, a typical day might include the following:

• Provides drug product manufacturing process knowledge and oversight for new product introduction, technology transfer, process troubleshooting and issue resolution.

• Acts as the technical lead and subject matter expert for technology transfer of the drug product manufacturing processes to manufacturing facilities.

• Tracks and reports project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.

• Reviews and approves cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities.

• Assists with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations.

• Trends process performance to establish/improve process capability to ensure process is operating within intended process control strategy.

• Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities.

• Supports development of sampling plans for GMP batches related to lot release, stability and characterization.

• Partners with and/or leads cross-functional internal/external teams to ensure process transfer execution

• Collaborates with internal and external teams to identify opportunities to improve process performance and cGMP operations.

• Assists with and/or leads in equipment selection, qualification and start up activities.

• Works with Manufacturing to ensure robust procedures are utilized for operation of equipment.

• Partners with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery.

• Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.

• Maintains required training status on Regeneron specific work instructions and SOPs.

• Works with DP MSAT management to define the organizational structure, identify and prioritize strategic initiatives to improve efficiency and compliance and assess human resource structure and requirements to meet growth projections.

• Leverages subject matter expertise to resolve issues that may arise and escalates to line management in a timely way to manage impact.

• Travels to contract manufacturers or business partners, as required, up to 25-50%.

This role might be for you if:

• Experience interacting with Contract Manufacturing Organizations.

• Demonstrated technical knowledge in drug product manufacturing, product development and validation.

• Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).

• Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills required.

To be considered for the Principal Engineer you must have a BS in engineering and 8 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience. To be considered for the Staff Engineer you must have a BS in engineering and 10 years of experience in a pharmaceutical / biologics cGMP environment 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 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)