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

Biologics Drug Substance Commercialization Team Leader

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.

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.

What We're Looking For:

Education:

• 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.

Required Skills:

• Technical Expertise: Proficient in the purification of biological molecules, including chromatography and filtration systems.
• Technology Transfer Experience: Proven track record in tech transfer or scaling up processes for biologics manufacture.
• Communication Skills: Exceptional oral and written communication abilities to articulate complex concepts in a multi-disciplinary team environment.
• Leadership Experience: Experience leading teams and fostering career development for junior staff.

Required Skills:

Biological Engineering, Biologics, Biomedical Engineering, Bioprocessing, Chemical Engineering, Chromatography, Communication, Data Analysis, Decision Making, Detail-Oriented, Downstream Manufacturing, Maintenance Supervision, Manufacturing Process Validation, Mentorship, Process Characterization, Protein Purifications, Team Management, Technical Leadership, Technology Transfer, Written Communication

Preferred Skills:

• 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).

The salary range for this role is $142,400.00 – $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st – Day

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 02/18/2026

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