Sr. Manager, Drug Product Engineering

Location
Rensselaer, NY, United States
Posted
Jun 05, 2019
Ref
16889BR
Required Education
Bachelors Degree
Position Type
Full time
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: Leads a team of employees, who develop robust drug product processes that enable Regeneron's mission to deliver life transforming medications to patients globally. The team is response for supporting each drug product unit operation from freeze/thaw, through filling and inspection. The team is responsible for development, industrialization, troubleshooting, and validation of drug product processes at manufacturing sites, both international and domestic.

Essential Duties and Responsibilities:

• Leads a team of engineers and scientists to develop fully characterized fill processes for new biologic drug products.

• Oversees all activities associated with biologics' fill processes including incoming inspection of components, developing and characterizing fill process parameters, managing technical transfer and validation of fill processes at CMOs, and supporting filling activities in manufacturing.

• Establishes and maintains an advanced analytical laboratory to support fill process development activities and development/manufacturing investigations.

• Manages investigations associated with fill processes to identify a root cause(s) and to identify and implement effective corrective and preventive actions.

• Reviews and/or approves manufacturing documentation associated with the transferred processes.

• Develops validation procedures reflecting best practices in the industry and provides on-the-floor support and oversight during process validation campaigns.

• Develops organizational standards and systems for filling processes to meet growing product portfolio.

• Establishes the standard procedures for fill process development activities and integrates those with other Regeneron business and quality systems.

• Establishes an internal and external network to stay abreast of current regulatory environment and industry standards.

• Support innovation mindset within organization and encourages development of novel ideas.

• Supports and mentors colleague at various levels within the organization. Development of colleagues in a key part of the role.

• Ability to see the big picture and to communicate a vision is critical to the role.

Knowledge, Skills & Abilities:

• A solid formulation in drug product processing, aseptic processing, drug product development, or pharmaceutical development is required.

• Perform hands-on experiments and in-process testing to support process development and product industrialization.

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Ability to maintain integrity and honesty

• Able to translate ambiguity into actionable steps

• Ability to resolve conflicts and coach others on problem solving

• Ability to handle issues appropriately and with a sense of urgency

• Ability to prioritize based on business needs

• Able to identify and effectively communicate risks

• Ability to problem solve and identify root cause

• Ability to communicate at all levels and across various functions

Travel Requirements:

• Up to 20% Travel may be required.

Education and Experience:

• Sr. Manager: BS/BA or higher, materials science, physics, chemistry, engineering or biological sciences with 8+ years industry experience.

*Manager level to be determined based upon 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.