Drug Product MSAT Engineer

Troy, New York, United States of America
Jul 23, 2021
Required Education
Bachelors Degree
Position Type
Full time
Summary: We are currently looking to fill a Drug Product Engineer position within our Drug Product Manufacturing Science and Technology team. This position will support equipment selection, CMO selection strategy, management of equipment qualification activities, and will be hands-on solving issues during technology transfer and cGMP start-up. The team will strive to establish standard methodologies for technical support of cGMP manufacturing operations. The position will also focus on ensuring site to site consistency after the processes are successfully transferred. The Engineer will also provide floor support during operations of off-site manufacturing, review process data to ensure operational consistency and provide support for investigations.

In this role, a typical day might include the following:
  • Providing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution
  • With the support of cross-functional teams, acting as the technical lead for technology transfer of the processes to manufacturing facilities
  • Tracking and reporting project achievements related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation
  • Reviewing and approving cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications) required to support cGMP production at manufacturing facilities
  • Assisting with investigation, root cause determination, and identify/implement CAPA for manufacturing deviations
  • Trending process performance to establish/improve process capability to ensure process is operating within intended process control strategy
  • Authoring policies, technical reports/protocols, change controls in support of cGMP activities
  • Supporting development of sampling plans for GMP batches related to lot release, stability, and characterization
  • Partnering with internal/external teams to ensure process transfer
  • Collaborating with internal and external teams to find opportunities to improve process performance and cGMP operations
  • Assisting in equipment selection, qualification, and start up activities and working with Manufacturing to ensure robust procedures are utilized for 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

Education and Experience:
To be considered for this role you must hold a Bachelor's degree in Engineering with 0-2+ years of related experience in a pharmaceutical / biologics cGMP environment for Associate level, 2+ years for Engineer level, 5+ years for Senior level. Experience in aseptic manufacturing and/or drug product technical transfer / technical support preferred. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

This role might be for you if you:
  • Have proven technical knowledge in drug product manufacturing, product development and validation
  • Have experience interacting with Contract Manufacturing Organizations
  • You continuously seek to improve processes for improved performance
  • Can work independently or as part of a team
  • Are OK with occasional travel up to 20-30% of the time

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.