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Director of Large Molecule Technology Transfer
vor 2 Monaten
We are seeking a highly motivated individual to lead our Large Molecule Technology Transfer team as an Associate Director. This role will be responsible for overseeing the end-to-end technical transfer leadership for technology transfers to all large molecules in pipeline and inline space.
Key Responsibilities- Manage and lead collaboration for TT related regulatory authoring and filing activities.
- Accountable to ensure TT project deliverables (metrics) are met and are on time.
- Develop and implement TT strategy and TT plan.
- Manage TT technical issues and escalations.
- Ensure TT standards and workflows are applied during TT.
- Provide end-to-end project management of the TT.
- Responsible for Data and Knowledge Management plans for TT and documentation.
- B.S. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of 7 years of relevant experience.
- Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.
- Ability to articulate TT to others.
- Establishes clear goals, delegates effectively, holds self and others accountable.
- Flexible and adaptable to dynamic situations.
- Strong scientific knowledge of multiple TT types including vaccines / biologics drug. substance, drug product and analytical.
- Proficiency with change control, deviation management and BLA/MAA regulatory license documents.
- Demonstrated creative conflict resolution and problem-solving skill.
- Strong knowledge of global regulatory guidelines and cGMP principles.
- Demonstrated experience with lean operational excellence in manufacturing.
- Digital tool competency with OnePMO, MS Teams, Power BI, MSPO, Spotfire, Share Points and other related systems.
- Master's degree in a related field.
- Experience in a similar role within the pharmaceutical industry.
- Strong leadership and management skills.
- Ability to work in a fast-paced environment.
Merck Sharp & Dohme (MSD) offers a competitive salary and benefits package, including bonus eligibility, long term incentive, health care and other insurance benefits, retirement benefits, paid holidays, vacation, and sick days.
