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

Job Description

Are you ready to make a significant impact on the world of biopharmaceuticals purification? At our company, we are at the forefront of innovation in our manufacturing division, specifically within the Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products into reality. Join us and be a part of a team that is dedicated to advancing the prevention and treatment of diseases in people and animals.

The Principal Scientist (Director level) position in BDSC-Downstream team is a senior scientific and people leadership role supporting late stage and commercial biologics programs, with a primary focus on biologics downstream 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 downstream strategies that directly support global manufacturing and regulatory success.

Reporting to the Director of BDSC-Downstream, the Principal Scientist (Director) will manage a team of downstream scientists and serve as a key technical leader and collaborator across Manufacturing, Quality, Regulatory, and external partners.

Responsibilities

• Lead downstream 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 a downstream subject matter expert across core unit operations, with a strong understanding of upstream, analytical, and GMP manufacturing interdependencies.
• Ensure process and product knowledge are developed, documented, and transferred in alignment with company standards and regulatory expectations.
• 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.
• Drive division-wide initiatives aligned with biologics manufacturing and commercialization strategy.
• Influence 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.
• Lead, coach, and mentor a team of downstream 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.

Qualifications

Required

• BS, MS, or PhD in Chemical Engineering, Biological Engineering, Chemistry, or a related discipline. 
• Minimum Years of experience: Fourteen (14) years (BS), Twelve (12) years (MS), or Six (6) years (PhD) of required industry experience.
• Deep technical expertise in downstream processing of biologics.
• 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

• Leadership experience on drug substance working groups or program teams.
• Direct people management experience.
• Hands-on experience with technology transfer, scale-up, and validation of biologics processes.
• In-depth knowledge of downstream unit operations, including preparative chromatography, tangential flow filtration, and virus retentive filtration.
• 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, Biologics, Biopharmaceutical Manufacturing, Bioproduction, Bioproducts, Chemical Engineering, Commercialization, Cross-Functional Teamwork, Decision Making, Downstream Processing, Drug Development, Manufacturing Scale-Up, Process Characterization, Process Development (PD), Process Transfers, Purification Methods, Strategic Thinking, Technology Transfer

Preferred Skills:

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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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/26/2026

*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.