Regeneron is currently looking for a Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer to support equipment selection, CMO selection strategy, management of equipment qualification and process validation activities. The DP MSAT Engineer 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. This role 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.
As a DP MSAT Engineer, a typical day might include the following:
- Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting and issue resolution for biopharmaceutical drug products.
- With the support of multi-functional teams, acting as the technical lead, with the support of cross-functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities.
- Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.
- Reviewing and approving cGMP batch documentation (e.g., master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities.
- Assisting with investigations and root cause determination and identifying/implementing CAPAs for manufacturing deviations.
- Trending process performance and collaborating with internal and external teams to establish/improve process capability to ensure the process is operating within the intended process control strategy.
- Authoring policies, technical reports/protocols, change controls, etc. in support of cGMP activities.
- Supporting the development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability etc.
- Partnering with internal/external teams to ensure manufacturing process transfer.
- Assisting in equipment selection, qualification, and start-up activities and working with Manufacturing to ensure robust procedures are used for the operation of equipment.
- Partnering with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment, and services to ensure external vendor on-time delivery.
This role might be for you if you:
- Have proven technical knowledge in aseptic / biopharmaceutical drug product manufacturing, product development and validation.
- Have experience interacting with Contract Manufacturing Organizations.
- You continuously seek to improve drug product manufacturing processes.
- Are willing to travel up to 20-30% of the time.
To be considered for the DP MSAT Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm and travel as need be. You must have a BS/BA Engineering; Chemical Engineering preferred. For various levels you must have the following:
- DP MSAT Engineer: 2+ years of relevant experience
- Sr. DP MSAT Engineer: 5+ years or relevant experience
Experience in aseptic / biopharmaceutical drug product manufacturing, product development and validation is preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)