Manager, Molecular & Cellular Biology

Catalent•Kansas City, MO

3d•Onsite

About The Position

Manager, Molecular & Cellular Biology Position Summary Shift: Monday – Friday 8am – 4:30pm 100% on-site Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Manager in Molecular and Cellular Biology is primarily responsible for managing various sub-teams comprised of a Group leaders, Scientists and Associate Scientists. Their responsibilities will include serving as technical experts on projects, act as liaison between client and Catalent technical team, coaching and mentoring group leaders, HR activities (e.g., performance reviews, time entry approval, PTO approval, salary adjustments, etc.), supporting client audits/visits, and communicating with cross-functional teams on analytical activities for Biopharma product development under cGMP regulatory guidance for Large Molecules/Biologics product development.

Requirements

Bachelor’s degree: >10 years of relevant experience in department specific techniques with more than 8 years of management experience preferred or based on performance at Catalent, OR
Master’s degree: >8 years of relevant experience in department specific techniques with more than 6 years of management experience preferred or based on performance at Catalent, OR
Doctorate Degree: >6 years of relevant experience in department specific techniques with more than 4 year of management experience preferred or based on performance at Catalent.
Applies knowledge of the principles, theories, and concepts applicable to a wide range of work in a discipline (e.g., Biology, Chemistry, Biochemistry) and broad knowledge of principles and concepts in other disciplines.
In-depth knowledge in instrumentation, theory, data interpretation and applications in at least one technical area. Can assess new technologies and their impact on Catalent offerings
Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones
Excellent written and verbal communications skills with internal and external customers, colleagues, and supervisor.
Ability to communicate complex technical information to non-technical audiences
Able to lead difficult discussions with customers and drive the to an acceptable resolution

Responsibilities

Supervise and manage various method development, method evaluation/feasibility, method transfers, method verifications, qualifications and validations, stability study and adhoc sample testing in Molecular and Cellular Biology.
Plan, prioritize, organize, and execute the conduct of analytical work within the Molecular and Cellular Biology Laboratory in accordance with the requirements of the client contract and/or technical agreement.
Serve as back up Project Technical Lead and could also serve as Technical Lead on projects pertaining to Molecular and Cellular Biology.
Manage and lead computer system validation activities, as required. Ensure various instruments/Equipment in the group are in compliant status.
Ensure cGMP practices are implemented and followed by the group and self.
Assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant in-house and client SOPs and methodologies and following the requirements of GMP.
Monitor and manage projects and maintain project timelines and budget.
Communicate effectively with clients, auditors, peers, and Directors to facilitate the smooth conduct of project activities.