# Associate Director, Biologics New Product Commercialization

Hiring organization: [Merck](https://career.thegoodapps.co/organizations/merck)

Canonical page: https://career.thegoodapps.co/jobs/20216271-d4c0-4c58-9ac4-4a3d6dd75bb6

Listed on Merck's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Salary: 142400 – 224100 USD per year

## Summary

This role leads the transfer of new monoclonal antibody products from research into commercial manufacturing, coordinating between internal labs, manufacturing sites, and external partners. It suits experienced biotech leaders who excel at managing complex cross-functional projects in regulated environments and can translate technical challenges into practical execution plans.

_Our summary, not Merck's wording._

## Skills named

Process Validation, Project Management, Risk Assessment, Strategic Planning, Technical Management

## Required

- Bachelor's degree in Chemical Engineering, Biotechnology, Biochemistry or related field with 8+ years post-graduate experience (or Master's with 6+ years, or Doctorate with 4+ years)
- Minimum 4 years leading projects in complex matrix organizations within regulated biopharmaceutical environments
- Minimum 2 years of experience with external manufacturing partners (CDMOs)
- Expertise in technology transfer methodology and technical problem-solving
- Demonstrated collaboration with R&D, manufacturing sites, analytical, quality, supply chain and regulatory functions

## Nice to have

- Deep technical knowledge of monoclonal antibody products and manufacturing processes
- Working knowledge of EMA, FDA, and/or USDA regulations
- Knowledge of Process Performance Qualification, Validation, risk assessments, and CMC regulatory processes

Apply on Merck's site: https://msd.wd5.myworkdayjobs.com/en-US/SearchJobs/job/USA---Kansas---De-Soto/Project-Manager--New-Product-Commercialization_R410313-1