Principal Scientist, Downstream Process Development

Merck & Co.; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision

Job summary

Merck & Co. is seeking a Principal Scientist to lead downstream processing of biologics in early and late-stage development at our Rahway, NJ site.

The role shapes purification strategies, guides cross-functional teams, and advances innovative bioprocessing technologies. The candidate will drive process development, characterization, and regulatory filings while mentoring staff and collaborating with senior leadership to set strategy.

Qualifications

• Ph.D. required with 6+ yrs industry exp or MS with 8+ yrs or BS with 10+ yrs in chemical/biochemical engineering.
• Deep expertise in downstream processing of biologics and CMC development.
• Proven ability to lead development projects and mentor staff.
• Strong track record of peer-reviewed publications and presentations.

Responsibilities

• Shape and realize innovation across biologics pipeline and science.
• Collaborate with cross-functional teams in fast-paced settings.
• Lead development of robust purification processes for biologics.
• Drive process characterization and regulatory filings for commercialization.
• Mentor teams and guide project strategy and execution.
• Promote safety, compliance, and inclusion.

Skills

Downstream processing

Process development

Leadership & mentoring

Cross-functional collaboration

Publications & presentations

Regulatory filings

Strategic thinking

Problem solving

Education

Ph.D. in Chemical/Biochemical Engineering

MS in Chemical/Biochemical Engineering

BS in Chemical/Biochemical Engineering

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 include but are not limited to:

• 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}

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$173,200.00 - $272,600.00

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.

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

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