Associate Principal Scientist, Biologics Drug Substance Commercialization (Assoc
Merck, West Point, PA, United States
Job Description
Are you ready to make a significant impact in the world of biopharmaceuticals purification? At our company, we are at the forefront of innovation in the Manufacturing Division, specifically within the Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification department is seeking a passionate and skilled individual to lead the charge in transforming our late‑stage pipeline and commercial products into reality. Join us and be part of a team that uses leading‑edge science to save and improve lives around the world.
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.
Actively interact with internal and external partners, representing your functional area on cross‑functional teams to foster collaboration and innovation.
Author regulatory and technical documentation, ensuring all processes align with the company’s expectations.
Manage a small team of junior staff, guiding them in their professional development.
Qualifications Required
A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience: Ten (10) years with a bachelor’s degree, Eight (8) years with a master’s degree, and Four (4) years with a PhD.
Proficient in the 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 to articulate complex concepts in a multi‑disciplinary team environment.
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 statistical methods for design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA).
Benefits & Compensation Salary range: $142,400.00 – $224,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits including medical, dental, vision, retirement benefits (including 401(k)), paid holidays, vacation, and compassionate and sick days.
Location & Work Model US and Puerto Rico residents only. Hybrid work model: employees in U.S. office‑based positions will work a hybrid schedule of three days on site per week and one remote day, with variations by site.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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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.
Actively interact with internal and external partners, representing your functional area on cross‑functional teams to foster collaboration and innovation.
Author regulatory and technical documentation, ensuring all processes align with the company’s expectations.
Manage a small team of junior staff, guiding them in their professional development.
Qualifications Required
A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience: Ten (10) years with a bachelor’s degree, Eight (8) years with a master’s degree, and Four (4) years with a PhD.
Proficient in the 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 to articulate complex concepts in a multi‑disciplinary team environment.
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 statistical methods for design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA).
Benefits & Compensation Salary range: $142,400.00 – $224,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits including medical, dental, vision, retirement benefits (including 401(k)), paid holidays, vacation, and compassionate and sick days.
Location & Work Model US and Puerto Rico residents only. Hybrid work model: employees in U.S. office‑based positions will work a hybrid schedule of three days on site per week and one remote day, with variations by site.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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