Associate Principal Scientist, Biologics Drug Substance Commercialization (Associate Director)
Merck
5 days ago
On-site
West Point, PA
Operations
Responsibilities:
- Lead cross-divisional technical teams on late-stage clinical process development, characterization, and technology transfer for biopharmaceutical drug substance processes.
- Conduct lab- and manufacturing-scale studies to support commercial process validation and characterization.
- Design experiments, analyze data, and mentor junior staff.
- Interpret trends from commercial process monitoring to drive investigations and process improvements.
- Represent functional area on cross-functional teams; collaborate with internal/external partners.
- Author regulatory and technical documentation to ensure processes meet expectations.
- Manage a small team of junior staff and support career development.
Qualifications:
Required:
- Degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry (10 yrs with BS; 8 yrs with MS; 4 yrs with PhD).
- Experience purifying biological molecules (chromatography, filtration).
- Proven tech transfer and/or scaling up for biologics manufacturing.
- Strong oral and written communication; ability to lead teams.
Preferred:
- Knowledge of harvest, preparative chromatography, and filtration.
- Pilot/commercial scale manufacturing experience.
- Familiarity with late-stage process development, characterization, validation submissions, and work with external contract organizations.
- Proficiency with DOE/data analysis, SPC, and MVA.
Skills (required): Cross-functional collaboration, data analysis, downstream processing/operations, manufacturing process validation & QC, process improvements, leadership/mentorship.
Preferred: Current employees/contingent workers apply via internal links.
Application: Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline: as stated on the posting.
- Lead cross-divisional technical teams on late-stage clinical process development, characterization, and technology transfer for biopharmaceutical drug substance processes.
- Conduct lab- and manufacturing-scale studies to support commercial process validation and characterization.
- Design experiments, analyze data, and mentor junior staff.
- Interpret trends from commercial process monitoring to drive investigations and process improvements.
- Represent functional area on cross-functional teams; collaborate with internal/external partners.
- Author regulatory and technical documentation to ensure processes meet expectations.
- Manage a small team of junior staff and support career development.
Qualifications:
Required:
- Degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry (10 yrs with BS; 8 yrs with MS; 4 yrs with PhD).
- Experience purifying biological molecules (chromatography, filtration).
- Proven tech transfer and/or scaling up for biologics manufacturing.
- Strong oral and written communication; ability to lead teams.
Preferred:
- Knowledge of harvest, preparative chromatography, and filtration.
- Pilot/commercial scale manufacturing experience.
- Familiarity with late-stage process development, characterization, validation submissions, and work with external contract organizations.
- Proficiency with DOE/data analysis, SPC, and MVA.
Skills (required): Cross-functional collaboration, data analysis, downstream processing/operations, manufacturing process validation & QC, process improvements, leadership/mentorship.
Preferred: Current employees/contingent workers apply via internal links.
Application: Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline: as stated on the posting.