Merck & Co, Inc

Assoc. Dir - Large Molecule External Manufacturing Technology, Network & Viral Lead

Merck & Co, Inc • $142K — $224K *
Elkhorn, NE 68022In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering, or related field
  • Minimum 10 years of relevant experience in biotech or pharmaceuticals
  • At least 5 years of experience in LM process development roles
  • Experience with viral vaccines and various LM drug substances including m-RNA, monoclonal antibodies, and antigens
  • Strong leadership, project management skills, and global mindset
  • Exceptional communication and interpersonal skills
  • Proficient in Microsoft Office Suite and scheduling tools

Responsibilities

  • Manage LM drug substance portfolio within a global CMO network
  • Lead technical transfer and process development projects
  • Oversee sourcing projects including vendor due diligence and selection
  • Ensure on-time delivery of drug substances through supplier management
  • Coordinate with cross-functional teams to define service requirements and project timelines
  • Drive innovation projects to improve process efficiency and reduce costs
  • Conduct audits and provide sourcing support as needed

Benefits

  • Flexible hybrid work arrangements
  • Opportunity to work in a pivotal leadership role
  • Engagement with a diverse, cross-functional team
  • Chance to lead innovative projects in drug substance technology
  • Development of skills in a high-impact and global environment
Full Job Description
Job Description

Responsibilities Include:

  • This new position is a pivotal role in the management of our LM drug substance portfolio in our global CMO (Contract Manufacturing Organizations) network, including responsibilities primarily in the commercial space supporting tech. As overall leader or technical leader you will be focusing on leveraging external suppliers for LM drug substance process transfer and/or development, scale up, full-scale production and commercial lifecycle management. You will be part of the External Manufacturing Technology Management Group and will be responsible for a portfolio of LM drug substance projects and/or supply nodes with a focus on in-line supply. The potential project types include sourcing, technical transfer, R&D, process improvement & innovation, and trouble shooting. The focus of this role is on network transfers for viral products.
  • In addition, spot audits and sourcing support on behalf of other team members will be required at times.
  • The role is global with a key focus on US and is a perfect fit for individuals with a strong drive for excellence and achieving tangible business results. Critical Skills include strategic thinking and proactive project management with business and technical acumen, verbal communication, and electronic communication. The individual needs to be able to act independently and travel as needed.
  • At the Associate Director level, a focus will be placed on the technical leadership during all aspects of drug substance sourcing, tech transfer, process development, commercialization, and subsequent lifecycle management. Once a supplier is selected, the individual will then be fully responsible for end-to-end execution of the project as the leader of execution managing both the internal drug product customers and the external supplier during the technical transfer or process development. Once the technical transfer, validation and regulatory approval for a sourcing project is completed and ready for assignment to in-line supply, leadership of our Company's Animal Health Supplier Technical Management program will be expected. In addition, each member of the technology team will contribute to generating innovation and systems improvements as appropriate.
  • The individual will be expected to partner with our Network team, Global Procurement, other functions in Science & Technology (S&T), Quality Assurance (QA) and our internal site manufacturing network to complete network transfer, global sourcing & development projects. Here the individual will define the requested services including generating technical packages, lead technical due diligence for supplier selection, and verify that the aspects of supplier selection are considered appropriately, including assurance of supply, quality, service, cost and innovation.
  • At all times, the individual must be adept at managing customer relationships, internal to the company and external suppliers.
  • Supplier Technical Management will be conducted to ensure the on time and full delivery of drug substance to our Company's Animal Health. The individual will be expected to manage a defined set of suppliers and act as steward for select drug substances and:
    • Lead cross functional meetings with the external suppliers and company's internal personnel to monitor the technical aspects of the relationship including tracking all changes, deviations, and improvement projects.
    • Lead the process change team inside of our Company's Animal Health working closely with our internal or external formulation facilities, regulatory, and quality to execute changes at the supplier.
    • Follow up on deviations and ensure they are resolved quickly and appropriately.
    • Ensure appropriate knowledge management of drug substance technology.
    • Develop and pursue innovation projects with the supplier to improve process efficiency and reduce Cost of Goods (COGs)
    • For R&D projects guide process development at the supplier. Leverage appropriate software systems including for supplier communication and change control.
  • Importantly, for all assignments the Associate Director must:
    • Provide strong leadership and business acumen for project management and lead cross-functional team members effectively.
    • Display our company's leadership behaviors and demonstrate a high emotional intelligence.
    • Create overall project schedules including input from cross-functional partners (regulatory, formulation, supply chain, quality, procurement, R&D) and ensure they are appropriate for the project delivering end to end outcomes.
    • Work closely with external suppliers to proactively develop or assess the manufacturing process, evaluate processing equipment and limit risks during scale up, transfer or process changes.
    • Present status updates via Microsoft Power Point in the relevant governance forum meetings
  • As required, the individual will assist communications with the suppliers during trouble shooting or visit facilities to conduct due diligence.


Education Required:

Bachelor's degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable

Required Experience or Skills:
  • Minimum 10 yrs. of relevant experience
  • The candidate must have experience in development of viral vaccines and a wide array of LM drug substances (monoclonal antibodies, antigens for vaccines, antibody drug conjugates, m-RNA etc.) as well as a demonstrated high level of technical capability.
  • A minimum of 5 years spent in LM process development roles.
  • A strong business acumen, communication skills, and a proven track record of managing projects in the areas of sourcing, process development & commercialization, tech transfer, manufacturing process troubleshooting and supply of biotechnology products.
  • Strong Leadership attributes including a global mindset.
  • Demonstrated ability to lead cross-functional teams with an end-to-end supply chain view.
  • Ability to collaborate across functions and geographies and support global activities.
  • Strong interpersonal and communication skills
  • Ability to maintain strong working relationships with technical, quality and operations leaders in the internal and external network.
  • Ability to use the Microsoft suite of applications and scheduling tools (Microsoft Project, Primavera etc.).


Preferred Experience and Skills:
  • PhD in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with a minimum 7 yrs. of relevant experience.
  • Deep understanding and experience in process scale up for LM drug substances.
  • Expertise in trouble shooting of upstream and downstream operations.
  • Demonstrated track record of managing technical project in global CMOs.
  • Experience in due diligence audits of CMOs.
  • Working knowledge of Regulatory strategy and execution in EU and US (FDA and/or USDA).
  • Six Sigma and/or Project Management Professional (PMP) certification preferred.


Travel: 15 to 20%

Required Skills:
Biologics, Good Manufacturing Practices (GMP), Manufacturing, Process Development (PD), Product Transfers, Project Leadership, Project Management Leadership, Technical Transfer, Technology Transfer, Vaccine Manufacturing, Vaccine Production, Vendor Evaluations

Preferred Skills:
Contract Manufacturing, External Manufacturing, Process Scale Up, Regulatory Strategies, Technical Project Leadership, Technical Project Management

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):
N/A

Job Posting End Date:
10/13/2026
*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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Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

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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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