Principal Scientist, Biologics Drug Substance Commercialization (Director)

**Job Description****Principal Scientist in Biologics Drug Substance Commercialization (Director)**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:**Current Employees applyCurrent Contingent Workers apply**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

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: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.**U.S. Hybrid Work Model**Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The salary range for this role is$173,200.00 - $272,600.00This 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 #J-18808-Ljbffr