Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.
Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.
Summary: 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 standard methodologies 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 optimally transferred and provides support for investigations.
Essential Duties and Responsibilities:
- 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 multi-functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities.
- Tracks and reports project achievements 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 applied 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 the need arises, up to 25-50%.
Education and Experience:
- Associate Engineer: Requires BS in engineering or equivalent combination of education and experience, 1- 2 years
- Engineer: Requires BS in engineering and 2 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience.
- Senior Engineer: Requires BS in engineering and 5 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience.
Knowledge, Skills and Abilities:
- 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.
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.