External Manufacturing Technical Lead – Large Molecule Drug Substance

Job Description

Join our Large Molecule Technical Operations Unit as an Associate Director Technical Operations. This role offers an exciting opportunity to work with key strategic external partners, grow technical experience in biologics manufacturing, and contribute to high visibility network initiatives. Our team is dedicated to providing technical excellence and being strong partners, collaborators, and leaders within the large molecule line of business at our company.

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

• Lead and act as the primary interface on technical issues between technical operations and the external partner.
• Provide technical leadership within the technical operations group for the commercialization and manufacture of drug substance.
• Provide technical guidance to the external partner, assess the viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
• Collaborate with procurement, external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) for inclusion in our company network.
• Execute technical due diligence assessments at external partner(s).
• Ensure tech transfers are positioned for successful business outcomes. Execute technical transfers and receiving site readiness activities.
• Execute identification and assessment of partner risks and develop mitigation plans.
• Execute validation strategies for new and existing products.
• Provide manufacturing process support to external partner(s) to resolve production issues and provide guidance on process and capacity optimization.
• Support, coordinate, and manage complex investigations, with appropriate interface with other impacted manufacturing sites.
• Provide a technical review of external partner process change requests, deviations, and master batch record changes. Minimize duplication of efforts between external partner and our systems.
• Drive and support continuous process verification and process performance monitoring program for all products under responsibility.
• Understand the true regulatory requirements and partner with operations, quality, and the external partner to develop more efficient ways to meet these requirements.

What skills you will need:

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

• Bachelor’s degree in engineering, biological/chemistry sciences or related discipline with a minimum of 10 years of relevant work experience in manufacturing, in the areas of process start-up, routine manufacturing, and/or technical transfer.
• Minimum of 5 years of experience in Drug Substance with experience in leading Drug Substance Technical Transfers and/or commercial manufacturing.
• Ability to work effectively across boundaries to build strong collaborative relationships with other internal teams, such as Global Technical Operations, External Services partner groups, and external partners.
• Strong professional and interpersonal communication skills.
• Authentic and inclusive people leadership, with examples of the ability to engage and create a psychologically safe and collaborative culture.
• Ability to multi-task and work within tight deadlines.
• Experience with change control procedures and systems.
• Flexibility and the ability to work independently as well as excellent organizational skills.
• Strong knowledge of Quality systems, Drug Substance Manufacturing, and Validation.
• Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation.
• Excellent command of English (both written and oral).
• Travel will be a requirement of this position up to 20%.

Preferred

• Experience in mAb DS.
• Lean Manufacturing / Six Sigma Experience.
• Project management experience.
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

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.

Required Skills:

Adaptability, Adaptability, Applied Engineering, Automation, Automation Systems, Capital Project Management, Change Control Processes, Change Management, Clinical Manufacturing, Data Analysis, Decision Making, Drug Product Manufacturing, Immunochemistry, Interpersonal Communication, Interpersonal Relationships, Investigation Management, Lean Manufacturing, Manufacturing Scale-Up, Manufacturing Support, Regulatory Compliance, Regulatory Inspections, Regulatory Requirements, Root Cause Analysis (RCA), Root Cause Analysis Training, Strategic Thinking {+ 2 more}

Preferred Skills:

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Current Contingent Workers apply HERE

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/23/2026

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