Principal Scientist, Biologics Development

MSD Malaysia; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

Retirement benefits (401k)

Paid holidays & leave

Job summary

Merck in the United States is seeking a Principal Scientist/Director for Biologics Drug Substance Commercialization to lead late‑stage and commercial programs focused on upstream cell culture and scale‑up. You will oversee a team of scientists, drive process development, and manage tech transfer and validation for licensure.

The role requires deep expertise in upstream biologics processing, regulatory awareness, and strong leadership.

Qualifications

• BS, MS, or PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or a related discipline with substantial industry experience.
• Deep technical expertise in upstream biologics processing and commercialization.
• Experience supporting biologics commercialization, including late‑stage development and/or commercial manufacturing.
• Proven ability to coach, lead, and develop scientific staff and collaborate across functions.

Responsibilities

• Lead upstream and/or integrated drug substance teams supporting late-stage clinical and commercial programs with clear line of sight to licensure and commercialization.
• Provide technical leadership for laboratory and manufacturing scale studies supporting characterization, validation, investigations, and continued process verification.
• Serve as an upstream subject matter expert across core unit operations with understanding of downstream, analytical, and GMP interdependencies.
• Ensure process and product knowledge is documented and transferred per regulatory expectations.
• Support technology transfer activities to internal and external sites, including scale‑up, process validation, and manufacturing readiness.
• Contribute to manufacturing investigations and lifecycle management for commercial processes.
• Author and review technical and regulatory documentation including sections for regulatory submissions.
• Drive division wide initiatives aligned with biologics manufacturing and commercialization strategy.
• Represent BDSC on cross functional and cross divisional teams; collaborate with internal and external partners.

Skills

Biologics

Biopharmaceutical Manufacturing

Biopharmaceuticals

Cell Cultures

CMC Biologics

Commercialization

Mammalian Cell Culture

Process Development

Product Development Lifecycle

Technology Transfer

Education

BS/MS/PhD in Chemical/Biological Engineering

Job description

Job Description

Job Description Summary: Principal Scientist/Director, Biologics Drug Substance Commercialization Join Our Company’s Manufacturing Division as a Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC). This senior leadership role is responsible for driving late-stage and commercial biologics programs, focusing on upstream cell culture and commercialization. The position oversees a team of scientists, leads high-impact process development, and manages technology transfer and validation activities to support licensure and commercial manufacturing.

Key responsibilities include providing technical leadership in process characterization, ensuring regulatory compliance, collaborating across cross-functional teams, and fostering innovation and operational excellence. Candidates should possess deep expertise in upstream biologics processing, proven experience in commercialization and scale-up, and strong leadership skills. Preferred qualifications include people management skills, hands‑on experience with advanced antibody therapeutics, regulatory submissions, and familiarity with analytical methods, cGMPs, and lean leadership principles. Educational requirements include a BS, MS, or PhD in a relevant discipline with substantial industry experience.

Key Responsibilities

Scientific & Technical Leadership

• Lead upstream and/or integrated drug substance teams supporting late-stage clinical and commercial programs, with clear line of sight to licensure and commercialization.
• Provide technical leadership for laboratory scale and manufacturing scale studies supporting process characterization, validation, investigations, and continued process verification.
• Serve as an upstream subject matter expert across core unit operations, with a strong understanding of downstream, analytical, and GMP manufacturing interdependencies.
• Ensure process and product knowledge are developed, documented, and transferred in alignment with company standards and regulatory expectations.

Commercialization & Technology Transfer

• Support technology transfer activities to internal and external manufacturing sites, including scale‑up, process validation, and manufacturing readiness.
• Contribute to manufacturing investigations and lifecycle management activities for commercial processes.
• Author and review technical and regulatory documentation, including sections supporting regulatory submissions.

Strategic & Cross Functional Impact

• Drive division wide initiatives aligned with biologics manufacturing and commercialization strategy.
• Influencing multi‑year planning: capability needs, digital systems, platform evolution.
• Represent BDSC on cross functional and cross divisional teams.
• Actively collaborate with internal stakeholders and external partners, including contract development and manufacturing organizations.

People Leadership & Development

• Lead, coach, and mentor a team of upstream scientists, fostering scientific rigor, accountability, and professional growth.
• Promote a culture of innovation, continuous improvement, and operational excellence within the laboratory environment.
• Support the leadership team with resource planning, staffing strategies, and hiring decisions
• Support talent development strategy, including developing future technical leaders and building a talent pipeline

Education

BS, MS, or PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or a related discipline, with: 16+ years (BS), 12+ years (MS), or 8+ years (PhD) of relevant industry experience.

Required Experience & Skills

• Deep technical expertise in cell culture process development and commercialization.
• Demonstrated ability to independently design, direct, execute, analyze, and document all stages of process development.
• Experience supporting biologics commercialization, including late‑stage development and/or commercial manufacturing.
• Proven ability to prioritize and deliver complex objectives in fast paced, dynamic environments.
• Strong leadership and collaboration skills within cross functional, matrixed organizations.
• Action oriented, problem‑solving mindset with a track record of innovation and continuous improvement.
• Demonstrated commitment to coaching and mentoring scientific staff.
• Excellent written and verbal communication skills, with the ability to clearly articulate process science and influence technical decision making.

Preferred Experience & Skills

• Leadership experience on drug substance working groups or program teams.
• Direct people management experience.
• Hands‑on experience with technology transfer, scaleup, and validation of biologics processes.
• Experience developing or supporting multi‑specific antibody therapeutics, including bispecific and other complex antibody formats.
• Experience with late‑stage process characterization, viral clearance studies, process performance qualification (PPQ), and validation.
• Experience authoring regulatory submission content (e.g., BLA sections) and/or working with external development or manufacturing partners.
• Working knowledge of analytical characterization of biologics, cGMPs, and U.S./EU regulatory expectations.
• Experience applying lean leadership and operational excellence principles in laboratory or manufacturing environments.

Required Skills: Biologics, Biopharmaceutical Manufacturing, Biopharmaceuticals, Cell Cultures, CMC Biologics, Commercialization, Mammalian Cell Culture, Process Development (PD), Product Development Lifecycle, Technology Transfer

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

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.

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

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

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.