Associate Principal Scientist, Biologics Drug Substance Commercialization (Associate Director)
Merck
6 months ago
Remote friendly (Rahway, NJ)
United States
Operations
Responsibilities:
- Lead/spearhead cross-divisional technical teams for late-stage clinical process development, characterization, and technology transfer of biologics drug substance processes.
- Perform lab- and manufacturing-scale studies to support commercial process validation and characterization.
- Design experiments, analyze data, and mentor junior staff.
- Interpret commercial process monitoring trends; drive investigations and process improvements.
- Collaborate with internal/external partners; author regulatory and technical documentation.
- Manage a small team of junior staff and guide professional development.
Qualifications:
Required:
- Degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry. Relevant experience: 10 years (BS), 8 years (MS), or 4 years (PhD).
- Purification of biological molecules (chromatography and filtration).
- Tech transfer or scaling up processes for biologics manufacture.
- Exceptional oral and written communication; experience leading teams.
Preferred:
- Knowledge of harvest, preparative chromatography, and filtration.
- Pilot/commercial scale manufacturing experience.
- Familiarity with late-stage development, characterization, process validation regulatory submissions, and external contract organizations.
- DOE/data analysis; SPC and MVA.
Benefits (if applicable): Medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days; annual bonus/long-term incentive (if applicable).
Application Instructions: Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the posting’s stated deadline (job posting effective until 11:59:59 PM the day before 04/25/2026).
- Lead/spearhead cross-divisional technical teams for late-stage clinical process development, characterization, and technology transfer of biologics drug substance processes.
- Perform lab- and manufacturing-scale studies to support commercial process validation and characterization.
- Design experiments, analyze data, and mentor junior staff.
- Interpret commercial process monitoring trends; drive investigations and process improvements.
- Collaborate with internal/external partners; author regulatory and technical documentation.
- Manage a small team of junior staff and guide professional development.
Qualifications:
Required:
- Degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry. Relevant experience: 10 years (BS), 8 years (MS), or 4 years (PhD).
- Purification of biological molecules (chromatography and filtration).
- Tech transfer or scaling up processes for biologics manufacture.
- Exceptional oral and written communication; experience leading teams.
Preferred:
- Knowledge of harvest, preparative chromatography, and filtration.
- Pilot/commercial scale manufacturing experience.
- Familiarity with late-stage development, characterization, process validation regulatory submissions, and external contract organizations.
- DOE/data analysis; SPC and MVA.
Benefits (if applicable): Medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days; annual bonus/long-term incentive (if applicable).
Application Instructions: Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the posting’s stated deadline (job posting effective until 11:59:59 PM the day before 04/25/2026).