Sr. Manager, DP Microbiology Formulation Development

Location
Tarrytown, New York, United States of America
Posted
May 21, 2021
Ref
25006BR
Required Education
Bachelors Degree
Position Type
Full time
This position will develop and implement microbiological programs within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. Main responsibilities will include establishment of microbiological test methods for Regeneron toxicology and clinical programs, aseptic support for drug product pilot lab fill/finish operations and serving as a key SME for laboratory maintenance and study designs.

A Typical Day in the Role of Sr. Manager Might Look Like:
• Lead the development, implementation, and oversight of microbiological testing programs supporting toxicology and clinical program development, including in-use microbial challenge studies supporting IV admixture and reconstituted DP supporting regulatory submission, sterility testing for preclinical developmental materials and microbial identification.
• Support the development of quality systems and SOPs for Microbiology programs in Formulation department.
• Generate training materials/content and provide training for applicable personnel on microbiological standard methodologies, principles and techniques.
• Provide SME support for deviations and investigations, working with testing laboratories and manufacturing organization on investigation actions, root cause analysis and product impact assessments.
• Support the hiring and development of Microbiology staff
• Serve as and SME during internal and external audits and regulatory inspections.
• Lead in a collaborative environment with a positive leadership style and hands-on approach that emphasize teamwork and consensus.
• Maintain project timeliness (i.e. implementation of new equipment, methods, studies, etc.)
• Lead through ambiguity and translate into actionable steps
• Identify and optimally communicate risks

This Role Might Be For You If:
• You have strong initiative and drive to complete ambitious tasks and learn new technologies related to formulation development.
• You are capable of multi-tasking, working both independently and within a team environment.

This role requires a Degree in Microbiology or a related field and industry experience with 5+ years in a leadership role. Extensive experience in developing and managing safety release testing of drug products and environmental monitoring programs. Experience in assessment of drug product sterility, manufacturing processes and facilities for microbial risk. Strong understanding of applicable USP, ICH, and Ph Eur regulations related to Microbial testing. Ability and desire to work in a fast-paced environment, manage large projects and implement microbiology programs. Strong collaboration, team-working skills and communication skills. Independently motivated with good problem-solving ability. Excellent oral and written communication skills are required.

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.