Associate Director, Tech Transfer Leader - West Point, United States - MSD

MSD

Verified Company

West Point, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

As part of our Company Manufacturing Division, within Global Science Engineering & Commercialization, the Large Molecule Science and Technology (LMS&T) is accountable for Large Molecule Commercialization, Technical Product Leadership and Technical Operations.

We are seeking a highly motivated individual for the role of Associate Director, Tech Transfer Leader in Large Molecule Technology Transfer within Technical Product Leadership.

This role will lead a team of scientists and engineers with a focus on end-to-end technical transfer leadership for technology transfers to all large molecules in pipeline and inline space.

The incumbent will demonstrate a deep expertise for people management leadership and the product/process sciences and engineering.

The incumbent will have broad, experience-based skillsets in Technology Transfers with key focus on standards and right first-time success for commercial scale manufacturing sciences/technology and in applicable business processes including program/portfolio management tools working with internal and external manufacturing partners and influencing technical strategy.

The incumbent will partner with groups across our Company and that includes the Global Human Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory-CMC, and Supply Chain.

The end-to-end scope includes Drug Substance and Drug Product for all large molecules. Associate Director is expected to contribute to ongoing business process improvements and all Tech Transfer (TT) activities.

Key Responsibilities:

Leading TT, Ensuring On-time Delivery:

Manages and accountable for the overall DS or DP technology transfer activities with endtoend visibility on sending and receiving site deliverables for the process, analytical and facility readiness. Manages and leads collaboration for TT related regulatory authoring and filing activities.
Accountable to ensures TT project deliverables (metrics) are met and are on time. Includes regulatory filing of related sections and regulatory approval of the TT node.
Accountable for overall TT strategy and TT plan. Accountable for detailed TT planning, TT schedules, gap assessments, risk assessments and mitigations, knowledge and data plans for that TT, stage gate readiness and reviews, supporting sending and receiving unit deliverables, authoring facility fit assessment and validation strategy documents, reviewing various sending (control strategy, comparability strategy etc.), and receiving site documents (validation protocols, Batch Reports, campaign summary reports, PPQ reports, investigation reports etc.), authoring BLA/MAA sections. Supports Person In Plant (PIP) activities.
Manages TT Technical Issues and escalations. Works under and with program leadership teams for program escalations and works with New Product Introduction/Operations lead for business unit operations escalations.
Ensures TT standards and workflows are applied during TT. Provides endtoend project management of the TT. Responsible for Data and Knowledge Management plans for TT and documentation.
Accountable for After Action Reviews and knowledge sharing with other TT teams.
Required to comply with our Company Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Work collaboratively to drive a safe and compliant culture.

Aligning with Stakeholders and Partners:

Leads crossfunctional, matrixed tech transfer team focused on Large Molecule TT of all types to achieve right firsttime validation with lineofsight to filing and licensure.
Builds strong crossdivisional partnerships with site leaders, functional management, and other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory-CMC, and Supply Chain, etc.)
Builds internal / external network.
Serves as primary point of contact and effectively communicates plans and issues related to TT.
Ensures that TT team is connected to the wider program teams and functional teams.

Planning / Governance:

Chairs TT endtoend meetings, Presents stage gates at TT local governance.
Aligns program and site goals to execute the TT.

Education / Capabilities requirements:

B.S. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of 7 years of relevant experience.

Leadership / Business Capabilities:

Manages effectively with diverse teams (crossfunctionally, crossculturally, and across internal / external sites) to align and drive TT results.
Viewed as a leader.
Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.
Works well in ambiguity.
Able to articulate TT to others.
Establishes clear goals, delegates effectively, holds self and others accoun