Director, Drug Product Development

Location
Tarrytown, NY, United States
Posted
Sep 26, 2020
Ref
20966BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Our Formulation Development group is seeking a Director of Drug Product Development to play an integral role to develop and implement strategies to develop biologics product formulations, manufacturing processes and analysis. In this role, you will provide scientific, technical and managerial leadership in support of drug discovery, product development and commercialization for both internal and external programs with partners. You will balance the need for efficiency and creativity in formulation development and characterization activities. You will develop platform strategies, standard operating procedures and ensure adherence to them. Furthermore, you will ensure research align with protocols and the department's Standard Operating Procedures. Reviews, edits, and provides direction for the writing of regulatory documents and scientific papers.

A Typical Day in this Role Might Look Like:
  • Lead a highly performing technical team of both PhD and non-PhD formulation scientists, providing oversight and direction for individuals and teams responsible for creating and executing DS /DP formulation development for all programs and therapeutic areas -- early, clinical and commercial stage
  • Craft, promote and improve formulation technical capabilities and related workflows in collaboration with other formulation group while taking a proactive role in developing and applying new formulation approaches; demonstrate creativity in solving complex technical problems
  • Organize and utilize resources to improve output while still being very innovative; development and disseminate your vision and goals for the group to connect each team members' work with the bigger picture
  • Build and maintains strong working relationships with relevant internal and external customers and partners; ensuring that activities are managed collaboratively, efficiently and effectively. Able to effectively influence across the organization
  • Interface with manufacturing to ensure the effective transfer of product formulations from research through commercial scale.
  • Provide input to the development of program strategy, budgets, timelines and formulation development plans. Ensure technical and business requirements are managed and met.
  • Is very comfortable dealing with ambiguity and a rapidly changing environment; can easily shift gears as needed and bring the team along
  • Demonstrates courage in all of his/ her interactions: excels at asking the tough questions, can take the heat and can make difficult decisions.
  • Displays strong analytical and strategic thinking
  • Guides and coaches others on day to day performance, long term career development and through change
  • Is well versed in protein stabilization methods and can advocate for approaches related to stability predictions models
  • Is a member of the Formulation Senior Leadership team and is a key technical and business leader
  • Regularly interacts with senior management and executives to create broad-based product formulation direction.
  • Interfaces with senior management to provide and obtain information and to build consensus regarding project direction.
  • Contributes to regulatory filings including IND's and BLA's; as needed assists in answering questions from regulatory authorities.


This Role Might Be For You If:
  • You have strong initiative and drive to complete challenging tasks.
  • You are capable of multi-tasking, working within a team environment.

The qualified candidate will have a minimum 10 years of industry experience in Biologics Drug Product Development, with at least 8 years of management experience -including managing PhD, non-PhD level scientists and other managers. Demonstrated knowledge, experience, and successful track record in formulation design with large molecules (antibodies and/or proteins) is required. Product development and filing experience with cell therapy, mRNA, siRNA and Gene Therapy preferred. Sound knowledge of GMP aspects of pharmaceutical research, development and commercialization processes is required. Established knowledge of applicable global regulatory requirements, experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters is essential.
Skills and Competencies:
  • Ability to effectively manage multiple responsibilities tasks, and projects simultaneously in a dynamic, fast-paced environment.
  • Excellent oral and written communication skills. Ability to communicate clearly and to present experiments results and data analysis, and persuasively present recommendations
  • Effective interpersonal skills. Ability to work in a team-oriented, cross-functional environment

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.