Associate Principal Scientist, Downstream Process Development

Merck & Co.; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co. in Rahway, NJ seeks an Associate Principal Scientist to lead biologic downstream process development and transfer activities for clinical and commercial manufacturing.

The role emphasizes high-yield, robust processes, mentorship, and cross-functional collaboration across Research, Manufacturing, and Analytics. The successful candidate will design experiments, supervise development work, and advance technology strategies while engaging with external partners and publishing findings.

Qualifications

• Proven record of accomplishments in downstream process and technology development.
• Engineering principles for recombinant protein purification unit operations.
• Able to direct planning, execution, analysis, and documentation of downstream process development.
• Ability to collaborate in a matrixed team with internal and external partners.
• Knowledge of biologics CMC development cycle.
• Initiative, creativity, and problem-solving.

Responsibilities

• Lead biologic downstream process development for first-in-human and commercial processes.
• Provide technical supervision for process development and characterization.
• Collaborate with upstream process development, Biologics Analytical R&D, and cross-functional teams.
• Advance downstream platform process strategy and drive process improvement initiatives.
• Assess new technologies and industry strategies relevant to the company.
• Collaborate with academia, industry partners, and vendors to drive development and adoption of new technologies.
• Stay updated on external patents and literature; present and pursue patenting strategies.
• Mentor junior scientists.

Education

Ph.D. with 3+ years of industry experience or Master with 6+ years or BS with 8+ years (Chemical/Biochemical Engineering or related)

Tools

TECAN

DeltaV

PCS 7

BioSMB / PCC

Job description

Job Description

Job Description In Primary Posting Language

The Biologics Process Research & Development organization within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and the development and implementation of new manufacturing technologies. We work with our partners in the company's Manufacturing Division to commercialize and launch new products.

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.

• 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)

Artificial Intelligence (AI), Cell Line Development, Chemical Engineering, Chromatography, Clinical Supplies Management, Clinical Trials, Column Chromatography, Commercialization, Cross-Functional Collaboration, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Interpersonal Relationships, Leading Project Teams, Manufacturing Processes, Molecular Biology, Multivariate Data Analysis, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Protein Purifications, Stable Cell Lines, Strategic Planning

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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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.

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

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

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: 10/1/2026

*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.

Requisition ID: R397371