Director, Drug Substance Dev & Mfg

Role Description

The Director of Drug Substance Development and Manufacturing in Technical Operations will guide and oversee drug substance development, clinical manufacturing, process characterization, and process validation for Star Therapeutics' development programs. They will be responsible for working with external partners and CDMOs to develop and implement the drug substance supply strategy that will span the various stages of the development program lifecycle, from early-phase clinical trials through the eventual late-phase clinical trials and commercialization.

Qualifications

• This role requires collaboration at the Team Leadership level with the Quality, Regulatory, and Supply Chain organizations to ensure successful development, technology transfer, manufacturing, commercial launch preparation, and routine supply
• Develop and execute project plans, including timelines, budgets, and resource allocation for drug substance development and manufacturing.
• Support technology transfer activities, including vendor selection, generation of risk assessments, process scale up/scale down, troubleshooting, etc.
• Negotiate contracts, timelines, and budgets with CDMOs and ensure alignment with company goals and project milestones.
• Monitor performance of CDMOs and ensure compliance with contractual obligations, quality standards, and regulatory requirements.
• Guide and collaborate with CDMO to design and perform robust process development, clinical manufacturing, process characterization, and process validation by employing phase-appropriate approaches (pre-clinical through commercialization) for CHO-based cell culture producing monoclonal antibodies and Fc-fusion proteins.
• Identify the critical quality attributes for the process intermediates and Drug Substance
• Design process development studies according to the principles of Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-factor-at-time (OFAT) and DOE studies to identify proven acceptable ranges (PARS) of critical process parameters (CPP) that impact critical quality attributes (CQA)
• Ensure drug substance development and manufacturing processes comply with global regulatory standards, including cGMP guidelines by performing Person-in-Plant activities during major manufacturing operations.
• Review Master/Executed batch records on a regular basis and provide suggestions in a timely manner
• Resolve issues that arise with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, and product trending,
• Establish, review, and implement stability program with the Analytical group for Drug Substance and reference standards.
• Provide regular updates to senior leadership on project status, risks, and mitigation strategies.
• Ensure reliable commercial drug substance supply for a monoclonal antibody by managing manufacturing schedules, capacity planning, and CDMO performance to maintain launch and post-launch supply timelines.
• Closely coordinate with Quality Assurance and Regulatory, as well as other CMC functions, Clinical and Toxicology to author and review IND, IMPD, BLA, and MAA filings.
• Organize, communicate, and present complex data sets to key stakeholders and senior management.
• Complying with all safety and GMP guidelines
• Requires up to 30% domestic and international travel.

Qualifications / Skills

• Demonstrated track record of successfully developing, transferring, and manufacturing drug substance at various scales and clinical stages
• Strong background in cell culture, chromatography, and filtration processes for monoclonal antibodies
• Strong grasp of statistical approaches for design of experiments (DoE) process development and characterization
• In depth knowledge of US (required) and European (preferred) regulatory requirements for cGMP
• Experience drafting, reviewing and submitting required documentation pertaining to the cGMP environment
• Late-stage experience, including process and product characterization, and validation
• Experience in commercial biologics drug substance manufacturing, including PPQ, CPV programs, process monitoring, and lifecycle management.
• Excellent strategic thinking skills with demonstrated ability to successfully create and implement short- and long-range plans to support product development strategy
• Proficient in analyzing technical data and preparing written technical reports
• Excellent oral and written communication skills, detail-oriented, scientifically driven
• Ability to navigate and be successful in a fast-paced work environment
• Experience in managing budgets, project timelines, and resources to accomplish objectives

Education / Professional Experience

• PhD or MS in chemistry, biology, bio/chemical engineering, or related discipline
• PhD with 10 years or Master’s degree with 12 years of experience in a scientific discipline related to biotechnology or pharmaceuticals, particularly in Analytical Development or Quality Control