Analytical Lab Manager (Drug Product)

Location
Rensselaer, NY, United States
Posted
Aug 21, 2020
Ref
20393BR
Required Education
Bachelors Degree
Position Type
Full time
Summary
Leads a team of scientist and engineers, 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 our new fill/finish manufacturing site.

Level to be determined based on qualifications relevant to the role

Essential Duties and Responsibilities
• Leads a team of engineers and scientists to develop fully characterized fill processes for 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 pilot 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.

General Drug Product Engineering Requirements
• 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
• Associate Manager: BS/BA or higher, materials science, physics, chemistry, engineering or biological sciences with 6+ years industry experience.
• Manager: BS/BA or higher, materials science, physics, engineering or biological sciences with 7+ years industry experience.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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