Biologics Process Development Scientific Lead

Job Description

The Biologics Process Development Scientific Lead provides technical leadership across biologics process development programs, with responsibility for driving functional alignment, leveraging established technology platforms, and ensuring knowledge is effectively shared and applied across projects.

This role is expected to help teams build on prior learnings, apply standardized and science-based approaches, and avoid duplicative work or reinvention of established solutions. It is important for this role to drive mechanistic understanding, innovate as needed to support a broad pipeline, evolve the platform to meet evolving needs.

The Scientific Lead partners closely with upstream and downstream process development to support integrated development strategies. The role provides subject matter expertise, influences technical decision-making across the portfolio, and helps ensure processes are robust, scalable, and suitable for clinical and commercial manufacturing.

Key Responsibilities:

• Provide scientific and technical leadership across biologics process development activities, spanning upstream and/or downstream unit operations as applicable.

• Champion platform-based development strategies to promote consistency, efficiency, and application of prior knowledge across programs.

• Drive knowledge sharing and functional alignment across projects to ensure teams are leveraging technology platforms, standardized methodologies, and prior knowledge in order to promote speed, consistency, and efficiency in process development.

• Facilitate knowledge capture, sharing, and transfer across development programs, ensuring lessons learned are incorporated into future work.

• Partner with cross-functional stakeholders to define and align technical strategy, development plans, and portfolio priorities.

• Design, execute, and/or oversee process development studies to improve productivity, product quality, robustness, and scalability.

• Support process optimization, characterization, scale-up, scale-down model development.

• Troubleshoot process challenges, evaluate root causes, and recommend data-driven solutions to improve performance.

• Interpret process, analytical, and manufacturing data to support decisions and communicate recommendations to project teams and leadership.

• Review and approve technical reports, protocols, development summaries, and documentation supporting regulatory filings and manufacturing readiness.

• Support a culture of scientific rigor, collaboration, and continuous improvement across the biologics development organization.

Education:

• PhD, MS, or BS in Biochemical Engineering, Chemical Engineering, Biology, Biotechnology, or a related discipline.

• 15+ years of relevant experience for PhD candidates, or 20+ years for MS/BS candidates, depending on scope and organizational needs.

Required Experience and Skills:

• Strong experience in biologics process development, with expertise in upstream cell culture/fermentation and/or downstream purification, depending on role focus.

• Demonstrated success in process development and process optimization, scale-up, technology transfer, and platform process development.

• Proven ability to lead across functions, influence without direct authority, and drive alignment across multiple projects.

• Excellent communication, collaboration, and project coordination skills.

Preferred Experience and Skills:

• Experience leading platform process strategies across multiple biologics programs.

• Familiarity with DoE, statistical analysis, process characterization, and scale-up/scale-down modeling.

• Experience supporting regulatory submissions and cGMP manufacturing.

• Exposure to integrated drug substance development and process lifecycle management.

Required Skills:

Biologics, Cell Cultures, Cross-Functional Leadership, Downstream Processing, Influence, Process Development (PD), Purification Methods, Scientific Thinking, Scientific Work, Technical Leadership, Technology Transfer, Upstream Processing

Preferred Skills:

Design of Experiments (DOE), Innovation, Platform Scales, Process Flow, Product Lifecycle

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.

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

The salary range for this role is

$210,400.00 - $331,100.00

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/International

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:

07/27/2026

*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.