Packaging Engineer (MSAT)

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) Packaging Engineer will serve as secondary packaging design and development lead for biologic product packaging (clinical and commercial) within the production network. The Packaging Engineer will also serve as a technical representative 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 the process subject matter expert providing oversite for development of package component artwork and specifications for components used for commercial production of Regeneron and partner products within the production network.

• Manages the package component supplier network to assure alignment of package component production capability with equipment platforms within the Regeneron production network. Coordinates establishment of new component suppliers to meet new product introductions and assure continuous component supply for packaging process development and commercial production.

• Collaborates cross functionally internally within Regeneron and externally with the established partners to develop the package component regulatory content for product filings and life cycle management changes.

• Executes development of new and revised package components as required for new product introduction or existing product lifecycle management according to the established implementation target. Collaborates cross functionally to develop the package component structural formats based on human factors outputs and equipment platform capabilities.

• Coordinates commercial artwork development, package component specification development and review and approval of these document types. Coordination of the change control process for the artwork and package component specifications associated with new product introductions and product life cycle management.

• Leverages subject matter expertise to resolve issues that may arise and escalates to line management in a timely way to manage impact.

• Works with MSAT management to define the packaging organizational structure, identify and prioritize strategic initiatives to improve efficiency and compliance and assess human resource structure and requirements to meet growth projections.

• Where applicable trends process performance, establishes data analytics to serve as metrics and assists in investigations and as feedback to process to achieve the intended process control strategy.

• Travel as required to CMOs or business partners, approximately 10-25 % travel (domestic and international).

• Assists in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance within the established production network.

• Maintains required training status on Regeneron specific work instructions and SOPs.

• Support managerial initiatives as required.

Knowledge and Skills:

• Demonstrated technical expertise in package development and packaging production process best practice for biologics, combination product and drug delivery devices. Package engineering and development preferred.

• Graphic Arts development process experience and CAD skills are a plus.

• Ability to manage projects and timelines as well as external vendors and partners.

• Familiarity with package testing best practice for biologics, combination products and devices.

• 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 Engineer - Requires BS in Packaging Engineering or related Engineering field, with 0-2 years of related experience.

• Engineer - Requires BS in Packaging Engineering or related Engineering field, with 2+ years of related experience.

• Senior Engineer - Requires BS in Packaging Engineering, or related Engineering field, with 5+ years of related experience.

*Title 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.

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-DR1