Principal Drug Product Engineer (Material Science & Engineering)

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.

Summary: Provides engineering support for the design and development of robust drug product processes that enable the delivery of life transforming medications to patients globally. The individual will support drug product unit operations from primary container development through drug product filling and inspection, with specialization in the development, industrialization, and technical oversight of primary container components. The individual will provide additional work as part of a team to support the industrialization, troubleshooting, and validation of drug product processes at manufacturing sites, both international and domestic.

Level to be determined based on qualifications relevant to the role.

Essential Duties and Responsibilities:

• Support primary container component design, development, selection, and use in Drug Product.

• Collaborate with cross-functional teams to define and execute drug product process development and technology transfer activities. Provide engineering expertise to cross-functional teams.

• Design, model, and implement scale-up strategies for drug product unit operations with a focus on process characterization, identification of critical process parameters and process optimization

• Write and review product industrialization protocols and reports to support technology transfer and process validation.

• Support product life-cycle initiatives.

• Support process investigations and assist with product impact assessment for change controls and internal/external investigations

• Perform at-scale hands-on experiments and in-process testing to support container characterization, process development and product industrialization.

• Continuously drive to improve processes for improved performance

• Other duties assigned by manager

• Up to 20% Travel may be required.

Knowledge, Skills, and Abilities:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Ability to multi-task

• Ability to analyze and identify trends

• Develops and delivers effective presentations

• Problem-solving skills

• Ability to train others on basic systems and processes

• Strong written communication

• Ability to work in an ever-changing environment

• Critical thinking skills

Education and Experience:

• Principal Engineer: BS in engineering with 8+ years industry experience; MS with 7+ years industry experience, PhD with 2 years industry experience.

• Staff Engineer: BS in engineering with 10+ years industry experience; MS with 9+ years industry experience, PhD with 5 years industry experience.

• Sr Staff Engineer: BS in engineering with 12+ years industry experience; MS with 11+ years industry experience, PhD with 8 years industry experience.

• A background in aseptic processing, drug product development, or pharmaceutical development is preferred, but not required.

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.
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