Associate Principal Scientist/Associate Director, Engineering- Biologics Drug Substance Commercialization

Merck • Rahway, NJ

4d • 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.
What You'll Do:
As a key player in our BDSC team, you will:
Lead and Collaborate: 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. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in our expanding late-stage biologics portfolio.
Drive Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You’ll design experiments, analyze data, and mentor junior staff, ensuring excellence in execution.
Enhance Process Understanding: Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.
Engage Across Functions: Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation.
Document Excellence: Author regulatory and technical documentation, ensuring all processes align with our company’s expectations.
Mentor Future Leaders: If you have a knack for leadership, you will also manage a small team of junior staff, guiding them in their professional development.

Requirements

• A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience: 10 years with a bachelor's degree.
• 8 years with a master's degree.
• 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.
• 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.
• Author regulatory and technical documentation.
• Manage a small team of junior staff, guiding them in their professional development.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree