Director, Downstream Biologics: Processes & Strategy

MSD; United Kingdom; On-site; GBP 128,000 - 202,000; Full time

Job summary

Merck & Co., Inc. in the United States seeks a Principal Scientist (Director level) to lead downstream development for late-stage and commercial biologics. The role focuses on process characterization, tech transfer, and cross-functional leadership to support global manufacturing goals.

The position requires deep technical expertise in downstream processing, strong collaboration skills, and a track record of driving innovation and regulatory readiness across complex biologics programs.

Qualifications

• Deep expertise in downstream processing of biologics.
• 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 leadership and collaboration skills within cross-functional, matrixed organizations.

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 is 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.

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

Education

BS, MS, or PhD in Chemical Engineering, Biological Engineering, Chemistry, or related field

Job description

Merck & Co., Inc. in the United States seeks a Principal Scientist (Director level) to lead downstream development for late-stage and commercial biologics. The role focuses on process characterization, tech transfer, and cross-functional leadership to support global manufacturing goals.

The position requires deep technical expertise in downstream processing, strong collaboration skills, and a track record of driving innovation and regulatory readiness across complex biologics programs.