Manager, Packaging 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: The Manufacturing Science and Technology (MSAT) Manager requires in depth knowledge of current device assembly and packaging processes and associated equipment for biologics product production. The MSAT Manager will support the production network strategy development, including capacity assessmnent and device assembly and packaging equipment selection and placement of that equipment within the production network. The MSAT Manager will be the recognized device and package production subject matter expert responsible for development of the equipment platform functional requirements and qualification activities. The MSAT manager will advise on early phase vial, device and combination products development providing information regarding existing production capability and package format options and develop and implement new capabilities and package formats as required. The MSAT Manager will receive vial, device and combination products technology transfer documents defining the final product formats for commecialization. The MSAT Manager will develop and implement integrated commercial processes for commercialization of new product introductions and product life cycle management to meet or exceed business expectations.

Essential Duties and Responsibilities include, but are not limited to the following:

• Serves as a technical manufacturing expert for device assembly, product labeling and finished packaging activities within the production network supporting development of new processes as required for new product introduction or existing product lifecycle management. Provide technical process troubleshooting and issue resolution.

• Lead device assembly, labeling and packaging equipment assessment, selection, qualification, and start up activities. Collaborate with Manufacturing to ensure robust procedures are established and utilized for operation of equipment.

• Act as the device assembly and packaging production technical lead within the cross-functional teams tasked to support technology transfer of device assembly or packaging processes within the production network.

• Collaborate cross functionally to support development of device and component specifications and test methods.

• Establish best practices for technical support of cGMP manufacturing operations. Focus on ensuring site to site consistency during the technology transfer of processes.

• Track and report project milestones related to device and package component procurement, equipment readiness and manufacturing documents creation.

• Provide on site support during establishment of new or modified production processes, review process data to ensure operational robustness and consistency.

• Provide subject matter expertise and lead device and packaging production related investigations to identify root cause, and identify and implement CAPA for manufacturing deviations.

• Review and approve cGMP batch documentations (e.g. master packaging batch records, component specifications, validation protocols, and component specifications) required to support cGMP production within the production network.

• Draft device assembly and packaging process related regulatory filing sections as required to support new product introductions and amendments to approved filings.

• Where applicable trend process performance, establish data analytics to serve as metrics and to assist in investigations and as feedback to process to achieve the 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 transfers.

• Collaborate with internal and external teams to seek out opportunities to improve process performance and cGMP operations.

• 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.

• 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 device assembly and packaging operations.

• Previous experience providing technical support.

• Experience interacting with internal manufacturing operations and Contract Manufacturing Organizations.

• Demonstrated technical expertise in device assembly and packaging operations and/or process 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.

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.

*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.
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