Merck & Co, Inc

Associate Director, Technical Operations (Drug Substance)

Merck & Co, Inc • $142K — $224K *
Wilmington, DE 19805Hybrid
Pharmaceuticals & Biotech
8 - 10 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering, science or related discipline.
  • 8+ years in a cGMP biological, vaccine or pharma facility.
  • Proven ability to lead activities such as FAT, SAT, IQ/OQ, and Engineering batches.
  • Experience with shakedown, engineering, and PPQ runs production.
  • Flexibility to adapt to changing project priorities.

Responsibilities

  • Lead collaboration with engineering firms on drug substance manufacturing design.
  • Drive Process Hazard Analyses and Quality Risk Assessments.
  • Participate in factory and site acceptance testing (FAT/SAT).
  • Develop and guide project-specific documentation.
  • Execute automation sprints in drug substance operations.
  • Support qualification deliverables like equipment commissioning.
  • Create and revise technical documents such as batch records and SOPs.
  • Provide expertise in conjugation, chromatography, and manufacturing support.

Benefits

  • Medical, dental, and vision healthcare for employees and families.
  • Retirement benefits including 401(k).
  • Paid holidays and vacation.
  • Compassionate and sick leave days.
  • Eligibility for annual bonus and long-term incentive programs.
Full Job Description
Job Description

In this position the Technical Operations Associate Director will play a pivotal role in ensuring oversight of various aspects of manufacturing, change management and technology transfer of programs to the site. In partnership with site manufacturing team will provide comprehensive manufacturing and technical leadership to the DS organization supporting the continued build, commissioning and qualification. This position will continue within the role from design through operation of the facility.

Responsibilities
  • Lead and engage with the engineering design firms in detailed design on all aspects of drug substance manufacturing.
  • Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.
  • Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
  • Develop project appropriate guidance documents as necessary.
  • Execute automation sprints as necessary in the drug substance area.
  • Support equipment qualification deliverables including equipment Commissioning & Qualification, IOQ, etc.
  • Creation, review and revision of technical documents including manufacturing batch records, SOPs and technical memos.
  • Provide Manufacturing and Technical expertise to the manufacturing team and leadership of the Technical Operations team, including areas such as conjugation, chromatography, tangential flow filtration and filling.
  • Oversee the Engineering Batches, Process Performance Qualifications and commercial manufacturing including authoring relevant filing sections.
  • Provide technical leadership for new product introductions (Tech Transfer).
  • Support technical deliverables within Drug Substance to support the successful product launch.
  • Provide manufacturing and technical support for RFT implementation and execution.
  • Communicate complex technical issues to stakeholders, external customers, agencies.

Qualifications

Required
  • Bachelor's degree in engineering, science or related discipline.
  • Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
  • Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
  • Previous experience of manufacturing and technical support of shakedown batches engineering batches, developmental batches and PPQ runs.
  • Ability to adapt to changing priorities as project demands change.
  • Demonstrated skills in planning, communication (oral and written) and technical writing.

Preferred
  • Start-up experience in a large-scale commercial drug substance facility highly desirable with hands-on experience with antibody drug conjugates highly preferred.
  • Expertise in chromatography and TFF operations will be advantageous.
  • Previous experience with CQV activities will be advantageous.
  • Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
  • Experience in a risk-based approach to manufacturing through use of tools such as FMEA.


#ADC

Required Skills:
Antibodies, Antibodies, Antibody Drug Conjugates (ADC), API Manufacturing, Change Control Systems, Change Request Management, Chemical Process Development, Chromatography, Cross-Cultural Awareness, Cross-Functional Teamwork, Detailed Design, Deviation Management, Equipment Qualification, Factory Acceptance Test (FAT), GMP Compliance, Hazard Analysis, Immunochemistry, Manufacturing, Manufacturing Process Validation, Operational Acceptance Testing (OAT), People Leadership, Process Optimization, Production Supervision, Regulatory Inspections, Regulatory Requirements {+ 8 more}

Preferred Skills:

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
08/6/2026
*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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

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We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

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Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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