Catalent, Inc.
Biopharma
Manager,Molecular&CellularBiology
“Manager, Molecular & Cellular Biology at Catalent, Inc.. Skills: Molecular & Cellular Biology management, cGMP compliance, client communication, method development and validation. Managing various sub-teams comprised of a Group leaders, Scientists and Associate Scientists. Serving as technical experts on projects”
Industry & Context.
100% on-site
What They're Looking For.
Must Have
Bachelor’s degree: >10 years of relevant experience in department specific techniques, Master’s degree: >8 years of relevant experience in department specific techniques, Doctorate Degree: >6 years of relevant experience in department specific techniques, Knowledge of the principles, theories, and concepts applicable to a wide range of work in a discipline (e.g., Biology, Chemistry, Biochemistry), 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, Experienced in most aspects of drug development and lifecycle support, Excellent written and verbal communications skills with internal and external customers, colleagues, and supervisor, Ability to communicate complex technical information to non-technical audiences
Nice to Have
more than 8 years of management experience, more than 6 years of management experience, more than 4 year of management experience, Able to assess new technologies and their impact on Catalent offerings, Able to develop useful strategies and tactics to meet regulatory milestones, Able to lead difficult discussions with customers and drive the to an acceptable resolution
What You'll Do.
Managing various sub-teams comprised of a Group leaders
Scientists and Associate Scientists
Serving as technical experts on projects
Acting as liaison between client and Catalent technical team
Coaching and mentoring group leaders
Supporting client audits/visits
Communicating with cross-functional teams on analytical activities for Biopharma product development under cGMP regulatory guidance for Large Molecules/biologics product development
Supervising and managing various method development
method evaluation/feasibility
qualifications and validations
stability study and adhoc sample testing in Molecular and Cellular Biology
and executing 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
Serving as back up Project Technical Lead and could also serve as Technical Lead on projects pertaining to Molecular and Cellular Biology
Managing and leading computer system validation activities
Ensuring various instruments/Equipment in the group are in compliant status
Ensuring cGMP practices are implemented and followed by the group and self
Assuring 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
Monitoring and managing projects and maintaining project timelines and budget
How You'll Work.
Team & Collaboration
Communicating with cross-functional teams; Communicating effectively with clients, auditors, peers, and Directors
Communication Scope
Excellent written and verbal communications skills with internal and external customers, colleagues, and supervisor; Ability to communicate complex technical information to non-technical audiences
Process & Methodology
Monitor and manage projects, Maintain project timelines and budget
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