Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics

As part of Our Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for biologics. It is the division’s leader in sterile product and process development, responsible for late-stage commercialization activities including process scale-up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions, and support of significant manufacturing investigations.

About the role

The Principal Scientist will advance and commercialize biologics pipeline programs. As a member of the drug product team, the Principal Scientist will drive excellence in process characterization, scale-up, transfer, and process validation activities.

Responsibilities

• Execute and provide oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation.
• Lead and/or serve on cross-functional biologics drug product (DP) working groups and manage DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre-Approval Inspection) readiness, approval, launch, and post-launch support.
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Drive strategic initiatives (technical and/or business process related) in the department and with partner groups that enable more efficient and rapid commercialization of innovative products.
• Provide mentorship, technical oversight, and strategic guidance to employees. Use advanced experience gained on scientific/technical issues to guide others in addressing non-routine and/or difficult issues. Develop a process and product development plan. Influence decisions related to primary packaging and combination product design.
• Design and execute DP development and commercialization studies, new product introduction, and process validation at commercial sites.
• Ensure fit-for-purpose scale-down models are developed and employed. Establish and validate platform engineering and scientific models for sterile product and process commercialization.
• Innovate and drive best practices for commercial site tech transfer, facility fit, and development of the DP control strategy, including classification of process parameters, performance parameters, operating ranges, and in-process controls.
• Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
• Influence CMC regulatory strategy and be accountable for DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparations for agency meetings. Author and review regulatory submissions.
• Drive continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
• Establish and foster a culture of high performance, out-of-the-box thinking, innovation, learning, empowerment, diversity, and inclusion.

Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
• Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
• Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience.

Skills

Required Experience and Skills

• Experience with drug product process development, optimization, and/or process characterization of biologics (mAbs, ADCs, and/or fusion proteins).
• Experience with at-scale biologics drug product manufacturing and fill-finish operations.
• Experience with late-stage commercialization of biologics programs.
• Technical expertise in sterile drug product fill-finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
• Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
• Excellent oral and written communication skills. Ability to effectively articulate understanding of process science to drive decision-making, impact assessments, and design of studies in a multi-disciplinary team environment.

Preferred Experience and Skills

• Experience in biologics drug product fill-finish process optimization, scale-up, and technology transfer of sterile products to pilot/commercial.
• Operations experience in the manufacturing of potent and sterile drug products at pilot and/or commercial scale.
• Experience with commercialization of biologics programs through PPQ and launch.
• Working knowledge in analytical methods and product attributes for biologics.
• Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles.
• Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
• Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes.
• Experience in Data Analytics, Computer Modeling, and Digital Applications.
• Working understanding of analytical methods to characterize biologics and other sterile drug products.

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Annual bonus and long-term incentive, if applicable.

Pay

The salary range for this role is $173,200.00 - $272,600.00. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Schedule

• This position may require travel up to 25%.
• Flexible work arrangements: Not applicable.