Director/Principal Scientist, Biologics Drug Substance Commercialization (BDSC)

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.

Join Our Team as a Principal Scientist/ Director in Biologics Drug Substance Commercialization! 

Are you ready to make a significant impact in the world of cell culture process development & commercialization? At Our Company, we are at the forefront of innovation in the Manufacturing Division, specifically within the Biologics Drug Substance Commercialization (BDSC) team. Our Upstream Cell Culture department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products into reality.

Position Overview

Within Our Company’s Manufacturing Division, Biologics Drug Substance Commercialization (BDSC) provides upstream process leadership and laboratory capabilities that advance late-stage pipeline and commercial drug substance manufacturing for biologics. The BDSC organization plays a critical role in enabling licensure and commercial supply by delivering second generation process development, robust process characterization, and seamless technology transfer to internal and external manufacturing sites.

The Principal Scientist/ Director position in BDSC-Upstream team is a senior scientific and leadership role supporting late stage and commercial biologics programs, with a primary focus on biologics upstream processing. This position offers the opportunity to lead high impact scientific work across complex modalities, including multi-specific antibody therapeutics—while developing talent and shaping upstream strategies that directly support global manufacturing and regulatory success. The Principal Scientist/ Director will serve as a key technical leader and collaborator across Manufacturing, Quality, Regulatory, and external partners.

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:

Biological Engineering, Biological Engineering, Biologics, Biopharmaceutical Manufacturing, Biopharmaceuticals, Bioprocess Engineering, Bioproduction, Biotechnology Manufacturing, Clinical Manufacturing, Commercialization, Cross-Functional Teamwork, Decision Making, Downstream Processing, Driving Continuous Improvement, External Manufacturing, Manufacturing Scale-Up, Mentorship, Next Generation Science Standards, Process Characterization, Process Control, Process Design, Process Development (PD), Process Optimization, Process Transfers, Product Development Lifecycle {+ 6 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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

$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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/16/2026

*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.