Senior Specialist, Transfer Task force - Biologics/ Vaccine Manufacturing (Tech Transfer)

Merck•De Soto, KS

8d•Hybrid

About The Position

Join Us in Shaping the Future of Animal Health Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date. As a Senior Specialist Transfer Task Force Support - Biologics/Vaccine Manufacturing (Tech Transfer Project Management), you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally. Our team is focused on delivering site-to-site technology transfers for Large Molecule Animal Health vaccines across our US manufacturing network. The TTF Support will ensure successful site-to site transfer and provide project management support to our US manufacturing sites. Your expertise will ensure on-time, in-budget delivery and compliant, unconstrained supply of Animal Health vaccines supporting the growth of the business. Our team has end-to-end responsibility for successful site-to-site transfer execution and provides comprehensive support to manufacturing sites and Transfer Leads. We ensure a standardized approach for process transfers and collaborate closely with our manufacturing sites and global functions across regions. Join our team to help align transfer activities with our company's strategy and support site-to-site transfers within the US Region.

Requirements

Bachelor’s degree in life sciences, engineering, or related field.
3–5 years project/program coordination or management experience on complex biologics or vaccine projects, including tech transfers.
Experience with Quality Assurance processes and tech-transfer documentation
Awareness of global regulatory expectations
Strong communicator, organized, able to manage multiple projects and stakeholders.
Strong and effective communication and negotiation skills
Strong analytical and decision-making skills
Ability to work flexible hours to support various time zones
Good team-player skills and open mindset to work with different cultures
Strong networking skills with the ability to efficiently interact within complex organizations
Ability to maintain an overview of multiple (complex) projects and focus on key activities
Ability to work under high pressure and meet critical timelines

Nice To Haves

PMP/CAPM or equivalent certification
Experience with multi-site/global transfers
Knowledge of electronic document management and project tracking tools

Responsibilities

Provide end to end coordination of site to site technology transfer execution across all transfer blocks
Serve as the point of contact for donor and receiving sites and for global technical and quality functions
Support scoping and siting assessments and contribute to the development of transfer strategies
Ensure consistent use of transfer methodology, reporting, governance and standard tools
Gather and analyze data for fit to plant reviews and gap assessments
Work with subject matter experts in upstream, downstream, formulation, fill finish and lyophilization to translate process information for receiving sites
Ensure receiving sites understand required changes, preparation needs and expected outcomes
Provide technical support to the region based on knowledge of vaccine processes and biological manufacturing
Maintain transfer plans, schedules, action trackers, and risk and issue logs
Ensure timely follow up, clear communication of any changes, and strong alignment across teams
Prepare and organize transfer packages (e.g. process descriptions, critical quality attributes, critical process parameters, control strategy, sampling plans, and bills of materials)
Update dashboards, summaries and status reports for leadership and governance
Lead routine meetings, set agendas, record minutes and provide stakeholder updates
Update dashboards, status summaries and reporting tools for leadership and governance
Support training and coaching in transfer methodology across the region
Capture lessons learned and help refine tools, playbooks and standard practices

Benefits

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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