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MSD Associate Director Tech Transfer Leader United States, Upper Gwynedd Township 737918710
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Leading TT, Ensuring On-time Delivery:
Manages and accountable for the overall DS or DP technology transfer activities with end-to-end 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 end-to-end 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 cross-functional, matrixed tech transfer team focused on Large Molecule TT of all types to achieve right first-time validation with line-of-sight to filing and licensure.
Builds strong cross-divisional 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 end-to-end 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 (cross-functionally, cross-culturally, 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 accountable.
Flexible and adaptable to dynamic situations
Cross-functional team management; successful at indirect management.
Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.
Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.
Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.
Technical Capabilities:
Expertise in technical aspects of product commercialization and life cycle management
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.
Demonstrated ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans.
NOTICE FOR INTERNAL APPLICANTS
In accordance with all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Contingent Workers apply
US and Puerto Rico Residents Only:
if you need an accommodation during the application or hiring process.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by aagreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Expected salary range:
$135,500.00 - $213,400.00
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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