Immediate Start: DS Upstream Lead, Associate Director

6 days ago

Dublin, Ireland Merck Gruppe - MSD Sharp & Dohme Full time

Job Description

Are you ready to lead and make a significant impact in the field of Vaccine Drug Substance Upstream Manufacturing? Join our company as a DS Upstream Lead, providing leadership to the Vaccine Drug Substance Upstream Manufacturing Department and become an integral part of the DS Manufacturing Leadership team. This role offers an exciting opportunity to drive innovation and excellence in DS Upstream manufacturing, ensuring the highest standards of safety, compliance, and execution.

Your Core Responsibilities

- Lead and develop the DS Upstream Manufacturing Team, overseeing Material Preparation, Cell Culture, and Bioreactor Operations at our company Dundalk Facility.

- Manage GMP Operations, including schedule attainment, manufacturing output, capacity planning, and budget for the DS Upstream area.

- Develop and implement the Manufacturing Capability Development Strategy as part of the operational readiness plan, with a focus on Cell Culture Processes.

- Ensure GMP readiness and maintain compliance within the USP Manufacturing area, aiming for permanent inspection readiness.

- Collaborate with key stakeholders for Tech Transfer, ensuring adequate staffing and timely documentation closure (Batch Records, CAPA, Deviations, Technical Reports).

- You will have the opportunity to drive on-time C&Q completion and system release within the DS Upstream area, partnering with the C&Q team for Tech Transfer readiness.

- Promote a Safety First, Quality Always mindset with Inclusion for all, fostering a Right First Time Culture.

- Oversee documentation approvals (Change Control, Protocol, Deviation) and integration works within the Upstream Area, coordinating with QA/QC for GMP compliance and timely closure of deviation investigations and CAPA implementation.

Who You Are

- Bachelor’s degree in science, engineering, or related field.

- Experience in direct people leadership with a passion for talent development.

- Technical/operational experience with Cell Culture processes.

- Knowledge of cGMP quality systems and their application to manufacturing operations.

- Strong interpersonal and communication skills, both verbal and written.

- Excellent organizational skills with attention to detail and ability to deliver cross-functional, complex projects at site level.

Nice to Have, but not essential

- Knowledge of Vaccine Manufacturing desired with operational considerations for Biosafety advantageous.

- Experience in C&Q, System Release processes & Operations aspects of Tech Transfer highly advantageous due to the lifecycle stage of the facility.

Required Skills

- Cell Cultures

- Cross-Functional Teamwork

- Good Manufacturing Practices (GMP)

- Manufacturing

- Operations ProcessesPeople Leadership

- People Management

- Process Improvements

- Production Operations

- Strategic Planning

- Strategic Thinking

- Team Leadership

- Upstream Operations

- Vaccine Manufacturing

Preferred Skills

- Biosafety

- Lean Six Sigma (LSS)

- Technology Transfer Management

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