Principal Scientist, Downstream Process Development

MSD Malaysia; Rahway (NJ); On-site; USD 160,000 - 230,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Principal Scientist to lead downstream processing of biologics within BPR&D, shaping purification strategies for clinical and late-stage programs, and ensuring scalable pathways from candidate to commercialization.

You will collaborate with discovery, pre-clinical, and manufacturing teams, drive development and characterization of robust purification processes, oversee regulatory filings, mentor scientists, and champion a data-driven, compliant

Qualifications

• Ph.D. with 6+ years, MS with 8+ years, or BS with 10+ years of industry experience in chemical/biochemical engineering or related field.
• Expertise in downstream processing of biologics, including purification process development and tech transfer.
• Track record of peer-reviewed publications, presentations, and CMC development knowledge.

Responsibilities

• Shape and realize innovation across the biologics pipeline, strategy, and science.
• Collaborate with cross-functional teams from research to manufacturing in a fast-paced environment.
• Lead development of robust, scalable purification processes for biologics across clinical stages and regulatory filings.
• Improve efficiency and cost effectiveness of downstream processes through research and best practices.
• Collaborate with academia, industry, and vendors to drive new technologies.
• Partner with senior leaders to set project strategy and guide execution.
• Plan and execute projects with strong prioritization and problem-solving.
• Present findings at premier conferences, publish, and pursue patents.
• Represent BPR&D as a downstream bioprocess expert in internal and external forums.
• Mentor staff and promote talent development; champion compliance and safety.

Skills

Downstream processing

Biologics expertise

Process development

Cross-functional leadership

Mentoring

Communication

Education

Ph.D. in Chemical/Biochemical Engineering

MS in related field

BS in related field

Job description

Job Description BPR&D within our Company's Research Laboratories is on a mission to rapidly deliver biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies. To achieve this, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing while providing an inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field. As a Principal Scientist you will have the opportunity to influence the future direction of our Company's Downstream Processing of Biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design purification processes while developing technical strategies related to downstream processing for drug candidates in early- and late-stage development.

Responsibilities

• As an impactful contributor, shape and realize innovation across the Biologics’ pipeline, strategy, and science
• Advance the pipeline by collaborating with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environment
• Participate in or lead 1) development of robust and scalable purification processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for successful commercialization
• Advance downstream processes by improving efficiency and cost effectiveness through research and innovation, while assessing technologies and industry best practices
• Collaborate with academia, industry, and vendors to drive development and early adoption of novel process technologies
• Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams towards its execution
• Conceptualize, plan, and execute projects with effective organizational, prioritization and problem-solving skills
• Stay abreast of scientific and regulatory landscape; actively present (premier conferences), publish (peer-reviewed journals) and patent
• Represent BPR&D as a downstream bioprocess expert in internal, cross-functional project teams and external conferences/consortia
• Mentor and actively share expertise; guide career development; build strong, collaborative teams
• Champion compliance and safety; promote a culture of inclusion

Minimum Education Requirements

Ph.D. with 6+ years, MS with 8+ years, or BS with 10+ years of industry experience and background in Chemical/Biochemical engineering, or a related field

Required Experience, Skills, and Competencies

• Strong fundamental knowledge and subject matter expertise in downstream processing of biologics, recent advances, and challenges in the field
• Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of purification process development
• Track record of accomplishments in downstream bioprocessing with a history of peer-reviewed publications and presentations
• Knowledge of biologics CMC development
• Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment
• Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams
• Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate and problem-solve
• Demonstrated commitment to coach and mentor staff to maximize talent development and utilization
• Excellent interpersonal and communication skills

Preferred Experience & Skills

• Leadership of CMC development teams
• Continuous biomanufacturing integrated with process-analytical technologies
• High-throughput experimentation, automation, and process control
• Knowledge of protein expression, analytics, conjugation chemistry and formulation
• Biophysical, mechanistic and facility modeling; statistical analysis, data-science, machine learning, artificial intelligence

Required Skills

Adaptability, Adaptability, Artificial Intelligence (AI), Biomanufacturing, Bioprocess Engineering, Career Development, Cell Culture Process Development, Cell Line Development, Combination Products, Data Analysis, Finite Element Analysis (FEA), Innovation, Innovative Thinking, Leadership Mentoring, Manufacturing Operations, Pharmaceutical Process Development, Prioritization, Process Characterization, Professional Collaboration, Professional Networking, Protein Expression, Publishing, Quality by Design, Regulatory Filings, Strategic Initiative {+ 2 more}

Preferred Skills

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: EEOC Know Your Rights EEOC GINA Supplement 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. Learn more about your rights, including under California, Colorado and other US State Acts

Employee Status

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

Job Posting End Date: 10/1/2026

Location Statements

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

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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.