Associate Director, Downstream Technical Operations

Job Description

Are you a collaborative leader passionate about bringing life-saving medicines to patients? In this role, you will lead our technical operations team, playing a pivotal part in the downstream manufacturing of our current biologics and preparing our site to welcome exciting pipeline products. By partnering closely with our cross-functional leadership teams, you will provide the technical guidance and support needed to ensure safe, reliable, and successful manufacturing.

Bring energy, knowledge, innovation to carry out the following:

Technical Strategic Leadership

Provide technical oversight for downstream manufacturing processes, ensuring safety, quality, and process robustness.

Lead site readiness for new products, guiding teams successfully through technical transfer, engineering, and commercial milestones.

Champion continuous improvement by utilizing Lean and Six Sigma principles to optimize processes and drive digital transformation.

People Culture Leadership

Lead and inspire a diverse team of technical specialists, providing dedicated coaching and mentoring to help everyone reach their full potential.

Foster an inclusive, supportive environment cantered around continuous learning, collaboration, and shared success.

Quality Performance

Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards, keeping our site in a permanent state of inspection readiness.

Oversee technical documentation, change controls, and investigations (such as Corrective and Preventive Actions) to maintain high-quality standards.

Track key site metrics (like safety, quality, training, and production efficiency) to help the team meet its goals.

What skills you will need:

In order to excel in this role, you will more than likely have:

A degree (or equivalent experience) in Engineering, Science, or a related technical discipline.

8-10 years of experience leading and coaching teams within a collaborative, cross-functional environment.

Proven experience in drug substance biotechnology or pharmaceutical manufacturing, with specific expertise in downstream purification processing and technology transfers.

Key Skills:

Inclusive Leadership: A proven ability to mentor diverse talent, build strong relationships, and lead with empathy and clarity.

Technical Operational Excellence: Familiarity with Six Sigma, Lean methodologies, and managing complex technical projects.

Problem Solving Communication: An innovative mindset to resolve technical challenges, coupled with excellent communication skills to convey complex ideas clearly.

Regulatory Compliance: Solid knowledge of global health authority regulations and current Good Manufacturing Practice standards.

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

So, if you are ready to:

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

Required Skills:

Coaching, Corrective and Preventive Action (CAPA), Current Good Manufacturing Practice (cGMP), Downstream Processing, Lean Methodologies, New Product Introduction (NPI), Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Management, Technology Transfer

Preferred Skills:

Current Employees applyHERE

Current Contingent Workers applyHERE

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):

Job Posting End Date:

07/11/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.

Requisition ID: R405553