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

You are ready if you have:

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Cell Cultures, Cross-Functional Teamwork, Good Manufacturing Practices (GMP), Manufacturing, Operations Processes, People 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

Job Posting End Date:

09/24/2025

*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.

Requisition ID:R363291

DS Upstream Lead, Associate Director - Dundalk

Job Description