Sr. Engineer / Specialist, Drug Product 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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Support formulation, filling, development, industrialization, troubleshooting, and validation of Formulated Drug Substance and Drug Product at manufacturing sites, including Contract Manufacturing Operations.

Essential Duties and Responsibilities:

• Collaborate with cross-functional teams and with external organizations to support late stage drug product process development efforts and tech transfer at Contract Manufacturing Organizations (CMO's).

• Develop and review formulation process for manufacturing and writes protocols and product industrialization reports to support and plan technology transfer process and process validation.

• Provide regulatory filing support for drug product (IND, BLA, MAA, etc...) as well as support during regulatory inspection of site quality systems.

• Other duties assigned by manager.

General Drug Product Engineering Requirements:

• A background in aseptic processing, drug product development, or pharmaceutical development is preferred.

• Perform and review process investigations and product impact assessment for change controls and internal/external investigations.

• Perform hands-on experiments and in-process testing to support process development and product industrialization.

• Ability to work independently or as part of a team.

• Ability to communicate with transparency.

• Continuously drive to improve processes for improved performance.

• Ability to resolve conflicts and coach others on problem solving.

• Accountable for the technical performance and results of the team.

• Manages ambiguity.

• Manages others within a matrixed team using influence.

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

• Makes quality decisions with limited supervision

• Sets priorities

• Ability to write advanced reports

• May own or lead a project

• May mentor others and/or have direct reports

• Ability to work in an ever-changing environment

• Builds strong working relationships cross-functionally

• Communicates with transparency and active listening

Travel Requirements:

• 20% Travel is required.
Education and Experience:

• BS in engineering, materials science, physical or biological sciences with a minimum of 5 years industry experience, MS with a minimum of 4 years industry experience, PhD with 0-2 years industry experience.

Level will be commensurate with experience.

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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

#LI-KS1