Associate Principal Scientist, Biologics Drug Substance Commercialization (Associate Director)

Merck•Upper Gwynedd Township, PA

3d•Hybrid

About The Position

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. The Associate Principal Scientist (Associate Director) provides technical and scientific leadership to advance late-stage and commercial biologics from development into reliable manufacturing. This role is responsible for designing, scaling, and transferring purification processes that ensure biological drug substances are produced safely, consistently, and in compliance with regulatory requirements. By partnering closely with process development, manufacturing, quality, and regulatory teams, the Associate Principal Scientist helps establish robust control strategies that support product licensure and long-term commercial success.

Requirements

A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience: Ten (10) years of required experience 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.

Nice To Haves

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).

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 our company’s expectations.
Manage a small team of junior staff, guiding them in their professional development.

Benefits

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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