Associate Director, Drug Product Filling

We are currently looking to fill an Associate Director of Drug Product Manufacturing Sciences and Technology (Primary Packaging & Filling) position. This position will lead a team to provide equipment recommendations, assist in contract manufacturing organization (CMO) selection strategy and support equipment/facility qualification activities. In addition, the team will be accountable for primary packaging implementation, process technology transfer, validation and continued process verification as part of the product lifecycle management platform.

In this role, a typical day might include the following:
• Serving as a technical leader for drug product process development, new product introduction, technology transfer, problem solving and issue resolution within a GMP manufacturing environment
• Leading the aseptic manufacturing technical support team in formulation, single-use system mixing, filtration, filling (i.e. vial, pre filled syringe, cartridge, etc.), lyophilization, container closure integrity and visual inspection
• Developing and leading multi-functional teams for technology transfer of the manufacturing and bulk packaging process to/from CMO, partner and internal manufacturing facilities
• Supporting project achievements related to raw material/component procurement, equipment readiness, analytical method transfer and document creation
• Facilitating or leading investigations, root cause identification and CAPA implementation for manufacturing deviations
• Working to understand and improve process capability and uses sophisticated statistics/data analytics to develop metrics to ensure process is operating within intended control strategy
• Providing leadership in the development of sampling plans for cGMP batches related to lot release, stability and characterization
• Assisting in equipment selection, qualification and start-up activities, in conjunction with Manufacturing, Quality and Engineering to ensure robust procedures are utilized for equipment operation
• Leading and mentoring team members to ensure succession planning while influencing/implementing change across all levels of the organization

This role may be for you if you:
• Enjoy domestic and international travel up to 25% of the time
• Are experienced in technology transfer, manufacturing equipment, automation and process validation applicable to aseptic parenteral filling operations
• Have previous experience providing GMP technical support and interacting with global Contract Manufacturing Organizations
• Have proven technical expertise in drug product filling, product/process development, validation and lifecycle management

To be considered for this role you must hold a Bachelor's degree in a scientific or engineering subject area, or related field, with 10+ years of related experience in a pharmaceutical / biologics cGMP environment. Level is determined based on qualifications relevant to the role.

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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