Job Description

Job Description In Primary Posting Language

We are seeking a highly motivated and experienced individual to join our Downstream Process Development and Engineering group as an Associate Principal Scientist. In this role, you will work with a highly collaborative team of Scientists and Engineers to design and develop downstream purification processes in support of early and late-stage biological products. The scope and activities include designing and optimization of downstream unit operations such as cell harvest, filtration, chromatography, viral clearance, precipitation, crystallization, and continuous processing for batch and intensified/continuous bioprocesses. The role will also include strategic Applicants should have effective organizational and multi-tasking skills and strong communication skills both verbal and presentation of data is required. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing. Evidence of strong cross-functional collaboration, experience successfully mentoring junior scientists, leading projects, and an external presence through scientific excellence are expected.

JOB RESPONSIBILITIES:

The successful candidate will contribute to CMC development of our company's pipeline, playing an active role in development of downstream processes and transfer to clinical and commercial manufacturing sites. She/He will also develop strategies for process and pipeline-facing innovation.

Responsibilities include:
• Leading biologic downstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable processes. Independently designing and conducting experiments using relevant operational parameters and analytical inputs.
• Providing technical supervision for process development and characterization
• Collaborate with upstream process development, Biologics Analytical R&D, and other cross-functional teams in both Research and Manufacturing to advance biologics pipeline.
• Advancing downstream platform process technical strategy, and championing creative process improvement initiatives
• Assessing new technologies, sciences, and industry strategies and relevance to our company
• Collaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies
• Keeping up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies
• Mentoring junior scientists

EDUCATION REQUIREMENTS:
• Ph.D. with 3+ years of industry experience or Master with 6+ years industry experience or BS with 8+ years in industry experience in Chemical Engineering, Biochemical engineering, or a related field

REQUIRED SKILLS:
• Proven record of accomplishments in downstream process and technology development with a scientific publication and presentation track record.
• Scientific understanding of the engineering principles for recombinant protein purification unit operations. Proven ability to design and execute protein purification experiments independently.
• Ability to direct the planning, execution, analysis, and documentation of all stages of downstream process development.
• Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors
• Knowledge of biologics CMC development cycle
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

PREFERRED SKILLS:
• Experience with high throughput experimentation using automation platforms such as TECAN
• Experience using and/or programming process control systems such as DeltaV and PCS 7
• Experience with integrated and continuous processing and equipment including multi-column chromatography systems (BioSMB, PCC, or similar)
• Background or experience in data science approaches related to downstream processes and predictive modeling (multivariate data analysis, machine learning/artificial intelligence, leveraging PAT)

Required Skills:
Biologics, Biologics, Bioprocess Engineering, Bioproduction, Cell Line Development, Chemical Engineering, Chromatography, Clinical Manufacturing, CMC Development, Design of Experiments (DOE), Detail-Oriented, Downstream Process Development, Downstream Processing, Drug Delivery Technology, Drug Development, Drug Discovery Research, Expression Vectors, External Manufacturing, Independent Thinking, Interpersonal Relationships, Leading Project Teams, Matrix Management, Molecular Biology, Patentability, Pharmaceutical Formulations {+ 9 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
09/18/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.