Principal Scientist, Engineering

Job Description

We are seeking a strategic and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary program teams. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development and authoring of regulatory submissions.

Under the general scientific and administrative direction of the Head of Biologics Cell Culture Sciences and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual will be responsible for leading cross functional commercialization program teams and mentoring a team of scientists to support development activities, commercialization activities of the late-stage biologics pipeline and post-market commercial manufacturing support for commercial biologic products.

This challenging position requires a clear vision for program leadership, team development, demonstrated leadership skills, critical thinking abilities, effective technical and communication skills, deep cell culture subject matter expertise, a strong understanding of drug commercialization and the regulatory landscape.

In this role, the successful candidate will be responsible to

• Lead, manage and/or mentor leaders of large multifaceted projects of cross-functional teams.
• Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.
• Monitors performance and recommends schedule changes, cost adjustments or resource additions.
• Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.
• Provides timely and accurate information and status updates to project sponsors and management.

• Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff.
• Provide technical guidance in the various aspects of Cell Culture process development/commercialization for large molecule products.
• Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.
• Provide technical oversight of process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
• Champion compliance and safety; promote a culture of diversity, inclusion, and equity.

Minimum Education Requirements and Experience:

• Bachelors degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with fourteen (14) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry. OR
• Masters degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with twelve (12) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry. OR
• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry.

Required Experience, Skills and Competencies:

• Two or more (2+) years experience managing a team of scientists; completing people management responsibilities including both performance and talent management activities
• Proven leadership and project management skills to lead cross functional teams, drive initiatives and team performance.
• Demonstrated ability in leading teams with proven talent development skillsets.
• Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field
• Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.
• Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
• Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
• Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
• Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.
• Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
• Excellent interpersonal and communication skills

Preferred Experience and Skills

• Multi-year experience with cell culture process development for large biologics products.
• Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
• Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts)
• Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.
• Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles.

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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.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .

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