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:

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