Associate Principal Scientist, Biologics Drug Substance Commercialization (Associate Director)
Merck
6 months ago
Remote friendly (West Point, PA)
United States
Operations
Responsibilities:
- Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug substance processes.
- Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization.
- Design experiments, analyze data, and mentor junior staff, ensuring excellence in execution.
- Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements.
- Interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation.
- Author regulatory and technical documentation to ensure processes align with company expectations.
- Manage a small team of junior staff and guide professional development.
Qualifications:
Required:
- Degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience: 10 years (bachelor’s), 8 years (master’s), or 4 years (PhD).
- Proficiency in purification of biological molecules, including chromatography and filtration systems.
- Proven track record in tech transfer or scaling up processes for biologics manufacture.
- Exceptional oral and written communication abilities.
- Experience leading teams and fostering career development for junior staff.
Preferred:
- In-depth knowledge of harvest, preparative chromatography, and filtration techniques.
- Experience in pilot or commercial scale manufacturing of biological molecules.
- Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations.
- Proficiency in DOE/statistical analysis, SPC, and multivariate analysis (MVA).
Required Skills:
- Cross-functional collaboration, data analysis, leadership, mentorship, downstream processing/operations, manufacturing process validation, manufacturing quality control, manufacturing scale-up, process improvements.
Benefits:
- Annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting (Job Posting End Date: 04/25/2026; apply no later than the day before).
- Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug substance processes.
- Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization.
- Design experiments, analyze data, and mentor junior staff, ensuring excellence in execution.
- Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements.
- Interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation.
- Author regulatory and technical documentation to ensure processes align with company expectations.
- Manage a small team of junior staff and guide professional development.
Qualifications:
Required:
- Degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience: 10 years (bachelor’s), 8 years (master’s), or 4 years (PhD).
- Proficiency in purification of biological molecules, including chromatography and filtration systems.
- Proven track record in tech transfer or scaling up processes for biologics manufacture.
- Exceptional oral and written communication abilities.
- Experience leading teams and fostering career development for junior staff.
Preferred:
- In-depth knowledge of harvest, preparative chromatography, and filtration techniques.
- Experience in pilot or commercial scale manufacturing of biological molecules.
- Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations.
- Proficiency in DOE/statistical analysis, SPC, and multivariate analysis (MVA).
Required Skills:
- Cross-functional collaboration, data analysis, leadership, mentorship, downstream processing/operations, manufacturing process validation, manufacturing quality control, manufacturing scale-up, process improvements.
Benefits:
- Annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting (Job Posting End Date: 04/25/2026; apply no later than the day before).