Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
The Drug Product Manufacturing Science and Technology (DP-MSAT) Engineer 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 Manufacturing Science and Technology team will strive to establish best practices 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.
- Level to be determined based on qualifications relevant to the role*
Essential Duties and Responsibilities include, but are not limited to, the following:
Knowledge, Skills and Abilities:
- Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution.
- With the support of cross-functional teams, act as the technical lead for technology transfer of the drug product manufacturing processes to manufacturing facilities.
- Track and report project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.
- Review and approve cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities.
- Assist with investigation, root cause determination, and identify/implement CAPA for manufacturing deviations.
- Trend process performance to establish/improve process capability to ensure process is operating within intended process control strategy.
- Author policies, technical reports/protocols, change controls, etc. in support of cGMP activities.
- Support development of sampling plans for GMP batches related to lot release, stability, and characterization.
- Partner with cross-functional internal/external teams to ensure process transfer.
- Collaborate with internal and external teams to identify opportunities to improve process performance and cGMP operations.
- Assist in equipment selection, qualification, and start up activities. Work with Manufacturing to ensure robust procedures are utilized for operation of equipment.
- Partner with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery.
- Travel to contract manufacturers or business partners, as required. Domestic/international travel of approximately 25-50% may be necessary.
- Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
- Maintain required training status on Regeneron specific work instructions and SOPs.
Education and Experience:
- 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.
- Associate Engineer - BS in engineering with 0+ years of related experience in a pharmaceutical / biologics cGMP environment.
- Engineer - BS in engineering with 2+ years of experience in a pharmaceutical / biologics cGMP environment.
- Sr Engineer - BS in engineering with 5+ years of experience in a pharmaceutical / biologics cGMP environment.
- Principal Engineer - BS in engineering with 8+ years of experience in a pharmaceutical / biologics cGMP environment.
- Experience in aseptic manufacturing and/or drug product technical transfer / technical support preferred.
- Equivalent combination of education and experience considered.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies:
Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.