Manager CMC Program Management (Gene Therapy)

Troy, New York
Sep 23, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Manager/Senior Manager CMC Program Management position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Manager/Sr. Manager uses prior program management knowledge and experience to thrive in a science driven, multifaceted, innovative environment to help shepherd the development of drugs from preclinical stages to commercialization (bulk drug, drug product devices) to bring drugs to patients in need. We take on big ideas together. The individual uses project/program management, leadership and matrix management skills to plan and drive progress on critical development activities through various stages of a program lifecycle. The Manager/Sr. Manager plans and leads program activities, including the development and monitoring of program strategy plans, timelines and budgets while cultivating positive relationships with internal and external customers.

A typical day as a CMC Program Manager includes:
• Driving the evolution of CMC strategy by working with a cross-functional team and leading operational planning and implementation of CMC program plans
• Working with the Global Development team to integrate CMC strategy considering the interdependencies with clinical, regulatory, and commercial timelines
• Acting as the program ""subject matter expert"" providing ready knowledge of program landmarks, key results, interdependencies, and critical decisions
• Using scientific background and experience viral vector technologies, CRISPR/cas gene editing and RNAi to guide CMC development of associated therapeutics.
• Participates as an SME guiding CMO’s and advances business relationships with Regeneron’s development Collaborators
• Facilitating scenario planning and issue /risk evaluation and management; surface and drive resolution of key issues
• Ensuring quality and timeliness of results for the program are met.
• Initiates and coordinates the decision making and risk-management process.

This role might be for you if:
• Enjoy encouraging a positive team culture of ownership and accountability including continuous evaluation, recognition and process improvement
• Excel a proactively identifying issues and providing general guidance on resolving CMC program challenges by developing solutions, and is able to call out appropriately in a timely and effective manner
• Are proactive in trouble shooting and dealing with program, team and collaborator issues.
• Display comfort in various settings.
• Display a proven record of coordinating across multiple teams and driving action and accountability and facilitate conflict resolution
• Demonstrate Business and financial acuity and successfully engage with executive level management

To be considered for this role you must have a Bachelors' degree in a related field with 8+ years of pharmaceutical industry experience or equivalent combination of education and 5+ years of related program management experience with 3+ years direct CMC (biologics) related project management experience for the Manager level. At the Senior Manager level the role requires a Bachelors' degree in a related field with 10+ years of pharmaceutical industry experience or equivalent combination of education and 10+ years of related program management experience with 3+ years direct CMC (biologics) related project management experience. An advanced degree is preferred. 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.