Drug Product MSAT Engineer

We are currently looking to fill a Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer position. The Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, CMO selection strategy, management of equipment qualification and 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 off-site manufacturing, reviews process data to ensure operational consistency after the 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 for new product introduction, technology transfer, process troubleshooting and issue resolution.

• Acts as the technical lead, with the support of cross-functional teams, 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 and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations.

• 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.

• Assists 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.

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

• 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 Associate Engineer you must have a BS/BA in engineering or equivalent combination of education and experience. To be considered for the Engineer you must have a BS/BA in engineering and 2 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience. To be considered for the Senior Engineer you must have a BS/BA in engineering and 5 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 reasonabl