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About the Role

Guide and oversee drug substance development, clinical manufacturing, process characterization, and process validation for Star Therapeutics' development programs. Develop and implement the drug substance supply strategy with external partners and CDMOs, spanning early-phase clinical trials through late-phase clinical trials and commercialization.

Responsibilities

• Collaborate with Quality, Regulatory, and Supply Chain for 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, risk assessments, process scale up/scale down, and troubleshooting.
• Negotiate contracts, timelines, and budgets with CDMOs, ensuring alignment with company goals and project milestones.
• Monitor CDMO performance, ensuring compliance with contractual obligations, quality standards, and regulatory requirements.
• Guide and collaborate with CDMOs to design and perform robust process development, clinical manufacturing, process characterization, and process validation using phase-appropriate approaches for CHO-based cell culture producing monoclonal antibodies and Fc-fusion proteins.
• Identify critical quality attributes for process intermediates and Drug Substance.
• Design process development studies according to Quality by Design (QbD) principles, specification justification studies, and process characterization studies (OFAT and DOE) to identify proven acceptable ranges (PARS) of critical process parameters (CPP) impacting 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 regularly and provide timely suggestions.
• Resolve manufacturing and/or compliance issues, including handling deviations, complaints, out-of-specification investigations, Material Review Board investigations, and product trending.
• Establish, review, and implement stability programs 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 monoclonal antibodies by managing manufacturing schedules, capacity planning, and CDMO performance to maintain launch and post-launch supply timelines.
• Coordinate closely with Quality Assurance, Regulatory, 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.
• Comply with all safety and GMP guidelines.
• Travel up to 30% domestically and internationally.

Requirements

• 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, and 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.

Skills

• Cell culture
• Chromatography
• Filtration processes for monoclonal antibodies
• Statistical approaches for Design of Experiments (DoE)
• Process development
• Process characterization
• cGMP regulatory requirements (US)
• cGMP regulatory requirements (European)
• Drafting cGMP documentation
• Reviewing cGMP documentation
• Strategic thinking
• Technical data analysis
• Technical report preparation
• Oral communication
• Written communication
• Detail-oriented
• Scientific drive
• Budget management
• Project timeline management
• Resource management

Location

• Boston Metropolitan Area
• South San Francisco, CA (occasional travel)
• Onsite

Work Type

• Full-time
• Onsite

Experience Level

• 10+ years of experience (with PhD)
• 12+ years of experience (with Master’s degree)

Education Level

• PhD in chemistry, biology, bio/chemical engineering, or related discipline
• MS in chemistry, biology, bio/chemical engineering, or related discipline

Salary/Compensations

• $188,800 to $236,000 annually
• Eligible for bonus
• Eligible for Company's equity plan

Benefits

• Competitive benefits package

About the Company

• Star Therapeutics is a Phase 3 clinical stage biotechnology company.
• Discovers and develops best-in-class antibody therapies to transform the lives of patients with serious diseases.
• Founded by former True North executives, backed by top-tier biotech investors.
• Team has significant scientific, clinical, regulatory, and commercial experience with a demonstrated track record of success.
• Committed to patients for whom no or limited treatment options exist.
• Headquartered in South San Francisco, CA.
• Core Value: Patients are our Center of Gravity, partnering with patients to address unmet needs.
• Core Value: Propelled by Data, Guided by Intuition, Informed by Expertise, exploring new diseases, novel biology, and smart ways of working with urgency.
• Core Value: Mission Ready Crew, challenging conventional wisdom and fostering an environment of respect and continuous growth.

Equal Opportunity

• Star Therapeutics is an equal opportunity employer and values diversity.
• Does not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.