Job Description

Technical Operations Director, Drug Substance EXM

An exciting opportunity has arisen for a Director of Technical Operations, EXM Drug substance (DS), to provide strategic and hands-on technical leadership across our expanding biologics external manufacturing network in the US.

Reporting to the Head of Biologics Technical Operations DS, this role will set the standard for technical excellence and receiving-unit excellence across technology transfer, commercialization, and sustained manufacturing performance.

This role requires a leader who can translate process science into reliable manufacturing performance, build strong technical capability within the organization, and create the conditions for predictable, compliant, and sustainable supply across a complex biologics portfolio.

The Director will provide end-to-end technical stewardship for receiving-unit activities, ensuring that process, equipment, and control strategy knowledge are effectively transferred and embedded at site level, and that operational readiness is established early and comprehensively. The Director will drive organizational capability by coaching and leading high-performing scientists and engineers, championing continuous improvement, and embedding a culture of technical excellence, accountability, and receiving-unit readiness.

Success in this position will require deep expertise in biologics drug substance manufacturing, technical operations, and technology transfer, coupled with a demonstrated ability to lead through complexity, influence across functions and partners, and build high-performing teams of scientists and engineers. The ideal candidate will bring strong experience in receiving-unit readiness, external manufacturing and CMO engagement, regulatory and quality systems, and the practical application of risk management to deliver robust processes and durable performance.

Responsibilities

Primary Responsibilities

Technical Ownership & Process Stewardship

• Drive expectations of deep technical understanding of the CMO partner’s manufacturing facilities and equipment at scale and in their MSAT labs, achieved by and not limited to on-site presence at the CMO. Also drive expectations of deep process knowledge of the programs, scale down models and filings, and active engagement on-site with SU functions.

• Lead receiving unit New Product Introduction & Tech Transfer activities, ensuring deep understanding of the interconnectivity between operations and the science behind our products (e.g., end-to end risks, control strategy) to drive on-time and right-first time process and site introduction and to influence/guide development and characterization.

• Process equipment SMEs for the sites they are accountable for, connected to the network of other tech ops teams with similar equipment and/or processes.

• Provide on-site SME support during PPQ, early production and throughout commercial manufacture of our products; act as escalation point for multi‑site issues.

• Support health authority interaction (queries and audits) that affect site activities, working with CMO and internal CMC organisations to provide the necessary support (audits, submissions)

• Actively support commercialization teams in representing facility & operational considerations during development

• Drive product life cycle management – developing and implementing process changes to ensure long term product robustness and compliance and driving productivity through day-to-day application of MPS.

• Build strong partnerships across Manufacturing, Quality, Regulatory, Supply Chain, Process Development, and external partners to ensure effective knowledge transfer, aligned decision-making, and reliable execution across the network.

Investigations, RCA & Complex Problem Solving

• Serve as the technical authority for complex deviations, investigations, root cause analysis, change management, and inspection readiness, ensuring a high standard of scientific rigor, implementation of high quality, sustainable CAPAs and operational discipline.

• Feed understanding and learnings from supply production into development teams and across Operations teams.

Risk Management, Monitoring & Preventive Action

• Establish and support Proactive Process Monitoring at CMOs pre-PPQ and throughout the product lifecycle of product, including cross-site monitoring.

• Detect trends at site & cross-site, as well as cross programs as appropriate, sustain and/or improve performance, including leadership of technical risk reviews to drive timely mitigations and

• Own stewardship of product/process and unit‑operation knowledge management.

Change Control, Validation, QMS and Inspection Readiness support.

• Own or co‑ordinate change control strategy and execution for technical changes,

• Support/drive QMS processes: APR/CPV, process validation, deviations, audits/inspections, regulatory submissions.

• Ensure right level of at-site technical competencies and succession plan for competencies critical to biologics EXM team.

• Support adoption of business process improvement efforts and drive the identification of opportunities to streamline while ensuring compliance.

Education Requirements:

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Chemistry, or a related scientific discipline;

• advanced degree preferred.

Minimum Qualifications:

• A minimum of 10 years of relevant experience in biologics drug substance manufacturing, technical operations, process support, or technology transfer within the biopharmaceutical industry.

• Demonstrated experience leading technology transfer and receiving-unit readiness activities for late-stage clinical or commercial biologics programs.

• Strong knowledge of cGMP manufacturing, process validation, quality systems, deviation management, investigations, and regulatory expectations for commercial biologics manufacturing.

• Proven ability to lead cross-functional teams, influence senior stakeholders, and manage technical complexity across internal teams and external manufacturing partners.

• Excellent communication, problem-solving, and organizational skills, with the ability to operate effectively in a fast-paced, matrixed, and highly collaborative environment.

Required Skills:

Adaptability, Biological Engineering, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Biotechnology, Business Process Improvements, Change Agility, Consulting, Engineering Principle, Fast-Paced Environments, Investigative Skills, Lean Six Sigma Continuous Improvement, Manufacturing Scale-Up, Organizational Capability, People Leadership, People Performance Management, Pharmaceutical Biology, Process Characterization, Process Improvements, Risk Management, Strategic Thinking, Technical Leadership, Technical Operations, Technology Transfer

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/2/2026

*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.