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.
Position Summary: The Packaging Engineering Manager requires in depth knowledge of current device assembly and packaging processes and associated equipment for biologics product production. This position will support the production network strategy development, including capacity assessment and device assembly and packaging equipment selection and placement of that equipment within the production network. The Packaging Engineering Manager will be the recognized device and package production subject matter expert responsible for development of the equipment platform functional requirements and qualification activities. This person 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. This person will receive vial, device and combination products technology transfer documents defining the final product formats for commercialization. The Packaging Engineering 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. Provides technical process troubleshooting and issue resolution.
- Leads device assembly, labeling and packaging equipment assessment, selection, qualification, and start up activities. Collaborates with Manufacturing to ensure robust procedures are established and utilized for operation of equipment.
- Acts 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.
- Collaborates cross functionally to support development of device and component specifications and test methods.
- Establishes best practices for technical support of cGMP manufacturing operations. Focuses on ensuring site to site consistency during the technology transfer of processes.
- Tracks and reports project milestones related to device and package component procurement, equipment readiness and manufacturing documents creation.
- Provides onsite support during establishment of new or modified production processes, reviews process data to ensure operational robustness and consistency.
- Provides subject matter expertise and leads device and packaging production related investigations to identify root cause, and identify and implement CAPA for manufacturing deviations.
- Reviews and approves 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.
- Drafts device assembly and packaging process related regulatory filing sections as required to support new product introductions and amendments to approved filings.
- Where applicable trends process performance, establishes data analytics to serve as metrics and to assist in investigations and as feedback to process to achieve the intended process control strategy.
- Authors technical reports and protocols in support of cGMP activities.
- Supports development of sampling plans for GMP batches related to lot release, stability, and characterization.
- Partners with cross-functional internal and external teams to ensure successful process transfers.
- Collaborates with internal and external teams to seek out opportunities to improve process performance and cGMP operations.
- Manages external vendors to ensure delivery of raw materials, equipment, or services; on time and within budget.
- Travels to contract manufacturers or business partners, as required, approximately 25% travel requirement.
- Assists in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
- Maintains required training status on Regeneron specific work instructions and SOPs.
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 - Requires BS in a scientific/engineering discipline, or related field, with 6+ years of related experience in a pharmaceutical / biologics cGMP environment.
- Manager - Requires BS in a scientific/engineering discipline, or related field, with 7+ years of related experience in a pharmaceutical / biologics cGMP environment.
- Sr Manager - Requires BS in a scientific/engineering discipline, or related field, with 8+ years of related experience in a pharmaceutical / biologics cGMP environment
May consider equivalent combination of education and experience in lieu of education requirement. Level will be determined based on qualifications relevant to the role.
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.