Associate Director, Biologics Drug Substance Lead

Job Description
Are you passionate about biologics and ready to lead impactful projects in drug substance manufacturing?
We're looking for an
Associate Director
to join our Enterprise Go To Market team within
Biologics Science and Technology
.
In this role, you will be a key scientific and technical leader, guiding upstream and downstream operations, leading investigations, and supporting our teams with your expertise.
Bring energy, knowledge, innovation to carry out the following:
Lead the design, development, characterization, and technical transfer of biologics drug substance processes, ensuring on-time delivery that meets quality, scientific, and regulatory standards.
Manage detailed planning, risk assessments, and documentation for technology transfers, including regulatory filings and approvals.
Collaborate closely with internal teams across Research & Development, Commercialization, Operations, Quality, Regulatory, and Supply Chain, as well as external manufacturing partners.
Support continuous improvement initiatives and share knowledge across teams.
Uphold current Good Manufacturing Practices (cGMP) and promote a safe, compliant work culture.
Build strong, inclusive partnerships across diverse teams and sites.
Present progress and results at key governance meetings.
What skills you will need:
In order to excel in this role, you will more than likely have:
A Bachelor's degree in Biological Sciences, Chemical Engineering, Bioengineering, or a related field, with at least 7 years of relevant experience—or a Master's/Ph.D.
with 5+ years of experience.
Deep expertise in biologics drug substance operations, both upstream and downstream.
Effective communication skills and you are someone who keeps stakeholders informed and can explain complex technical topics clearly.
The ability to thrive in dynamic environments and can manage ambiguity with flexibility.
Strong leadership skills, able to motivate and guide diverse, cross-functional teams.
Experience in regulatory requirements, cGMP, and lean manufacturing principles.
Proficiency with digital tools like project management software, data visualization, and collaboration platforms.
Excellent problem-solving skills and the ability to drive results through collaboration.
Current Employees apply
HERE
Current Contingent Workers apply
HERE
Secondary
Language(s) Job Description:
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
.
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):
Required Skills:
Biologics, Commercialization, Communication, Cross-Cultural Awareness, Cross-Cultural Collaboration, Cross Cultural Management, Downstream Manufacturing, Downstream Operations, Downstream Process Development, Monoclonal Antibodies, Problem Solving, Regulatory Approvals, Regulatory Filings, Regulatory Frameworks, Regulatory Management, Regulatory Reporting, Stakeholder Management, Technology Transfer, Upstream Operations, Upstream Process Development
Preferred Skills:
Job Posting End Date:
08/7/2025
*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.
Requisition ID:
R358323
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