Principal Scientist, Biologics Drug Substance Commercialization (Director) Full-time NEW

Principal Scientist in Biologics Drug Substance Commercialization (Director)

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: Accountability, Chromatography, Clinical Manufacturing, Communication, Creativity, Cross-Functional Teamwork, Decision Making, Design of Experiments (DOE), Downstream Processing, Driving Continuous Improvement, Leadership, Manufacturing Scale-Up, Mentorship, Process Characterization, Process Control, Process Design, Process Optimization, Product Characterization, Regulatory Submissions, Strategic Thinking, Technology Transfer, Technology Transfer Management

Preferred Skills: