Regeneron Pharmaceuticals Manager, Drug Product Manufacturing (MSAT) in Rensselaer, New York
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: The Manufacturing Sciences and Technologies (MSAT) Manager will serve as parenteral drug product process experts for clinical and commercial medicines. The Manager will also serve as a technical representive for CMO selection strategy, equipment qualification activities, and will be hands on solving issues during technology transfer and cGMP start up. The MSAT 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, provide floor support during operations of offsite manufacturing, review process data to ensure operational consistency and provide support for investigations.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Serves as a technical manufacturing expert for drug product process development and new product introduction, technology transfer, and drug product technical process troubleshooting and issue resolution.
• With serve as key technical experts on the DP Project Teams for technology transfer of the drug product manufacturing, device assembly and final packaging processes at manufacturing sites withing the Regeneron DP Manufacturing network.
• Track and report assigned project milestones related to raw material procurement, equipment readiness, analytical process transfer, manufacturing documents creation and any other deliverables to the DP Project Team.
• Review and approve cGMP batch documentations (e.g. master batch records, packaging batch records, component specifications, validation protocols, and material specifications) required to support cGMP production..
• Provide SME support for investigations, identify root cause, and recommend effective CAPAs for manufacturing deviations.
• Provide technical assessments for change controls.
• Trend process performance. Establish data analytics to serve as metrics, to assist in investigations, and as feedback to Process Sciences to achieve the intended process control strategy. Ensure that the process is robust and operating in a validated state.
• Author technical reports and protocols 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 and external teams to ensure successful process transfer.
• Collaborate with internal and external teams to seek out 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.
• Travel approximately 25-50% is required (domestic and international).
• Assist in maintenance of 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 SOP’s.
Knowledge, Skills and Abilities:
• Technology transfer and equipment and process validation experience with aseptic parenteral filling operations.
• Previous experience providing technical support.
• Experience interacting with Contract Manufacturing Organizations.
• Demonstrated technical expertise in drug product manufacture and/or 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 qualification preferable.
• Fluent in English with a preference given to candidates with competencies in German, French and/or Spanish (oral and written).
Education and Experience:
• Associate Manager Level - BS in a scientific/engineering discipline, or related field with 6+ years of related experience, preferably in a pharmaceutical cGMP environment.
• Manager Level - BS in a scientific/engineering discipline, or related field with 7+ years of related experience, preferably in a pharmaceutical cGMP environment.
• Sr Manager Level - BS in a scientific/engineering discipline, or related field with 8+ years of related experience, preferably in a pharmaceutical cGMP environment.
Level will be determined based on skills and related 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.