Associate Manager, MSAT-Filling
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 Science and Technology (MSAT) Manager will serve as a process expert in 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 Manager will also 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 the support of cross-functional teams, act as the technical lead for technology transfer of the drug product manufacturing and packaging process to both partner and CMO manufacturing facilities.
• Track and report project milestones related to raw material procurement, equipment readiness, analytical process transfer, manufacturing documents creation, etc.
• Review and approve cGMP batch documentation (e.g. master batch records, packaging batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at external manufacturing facilities.
• Investigate, identify root cause, and identify/implement CAPA for manufacturing deviations.
• Trend process performance to establish/improve process capability, use data analytics to develop metrics and ensure process is operating within intended process control strategy.
• 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 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.
• Manage external vendors to ensure delivery of raw materials, equipment, or services; on time and within budget.
• Travel to contract manufacturers or business partners, as required, approximately 25-50% travel requirement.
• Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
• Responsible for leading, coaching, and developing direct reports.
• Maintain required training status on Regeneron specific work instructions and SOP's.
Knowledge, Skills and Abilities:
• 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.
• 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 lead and be accountable for team's performance and results
• Manage internal and external relationships
• Develop strategy and create metrics to measure effectiveness of strategy
• Lead through ambiguity and translate into actionable steps
• Provide leadership to direct and indirect reports
• Coaching and conflict resolution
• Handle issues appropriately and with a sense of urgency
• Prioritize based on business needs
• Identify and effectively communicate risks
• Ability to problem solve and identify root cause
• Ability to communicate at all levels and across various functions
• Ability to build, lead, and motivate team
Education and Experience:
• Associate Manager - BS in a scientific/engineering discipline, or related field, with 6+ years of related experience in a pharmaceutical / biologics cGMP environment.
• Manager - BS in a scientific/engineering discipline, or related field, with 7+ years of related experience in a pharmaceutical / biologics cGMP environment.
• Sr Manager - BS in a scientific/engineering discipline, or related field, with 8+ years of related experience in a pharmaceutical / biologics cGMP environment.
• Or equivalent combination of education and experience.
• Technology transfer and equipment and process validation experience with aseptic parenteral filling operations.
• Previous experience providing technical support.
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.