Star Therapeutics is searching for a Contract Drug Substance Development and Manufacturing-Technical Operations, to work approximately 20 hours per week. This contract position can be 100% remote, or hybrid and working 1-2 days out of our South San Francisco HQ.

As Contractor - Drug Substance Development and Manufacturing - Technical Operations you will guide and oversee drug substance development, clinical manufacturing, process characterization, and process validation for development programs for Star Therapeutics. You will be responsible for working with external partners and CDMOs to develop and implement the drug substance supply strategy that will meet various stages of the development program lifecycle including early phase clinical trials, through the eventual late phase clinical trials and commercialization.

Primary Responsibilities

1. Partner with Analytical, Quality, Regulatory, and Clinical teams to ensure successful technology transfer and routine drug substance supply.
2. Guide and monitor CDMO activities to ensure robust process development, clinical and commercial manufacturing, and process validation for CHO-based mAb and Fc-fusion protein production.
3. Review master/executed batch records and resolve manufacturing issues including deviations, OOS investigations, complaints, and MRB-related matters.
4. Design and interpret process development studies (e.g., OVAT, DOE) to define proven acceptable ranges (PARS) for critical process parameters (CPPs) impacting critical quality attributes (CQAs).
5. Identify and justify specifications for critical quality attributes of process intermediates and drug substance.
6. Collaborate on authoring and reviewing regulatory submissions (IND, IMPD, BLA, MAA) and provide data-driven support for specification setting and validation.
7. Establish and oversee stability programs for drug substance and reference standards to ensure product integrity over time.
8. Provide regular updates to senior leadership on project progress, risks, mitigation strategies, and CDMO performance.
9. Maintain adherence to GMP and safety guidelines across all manufacturing and development activities
10. Requires up to 20% domestic and international travel.

Qualifications / Skills

• Demonstrated success in developing, manufacturing, and transferring drug substance processes for biologics, particularly monoclonal antibodies.
• Advanced knowledge in physical chemistry, biochemistry, and production techniques relevant to mAb  manufacturing and process control.
• Proficient in applying statistical approaches, including Design of Experiments (DoE), for analytical method development and process characterization.
• Skilled in drafting, reviewing, and submitting documentation in a cGMP environment, including protocols, reports, and batch records.
• Strong strategic thinking with a track record of developing and executing short- and long-term plans aligned with product development goals.
• Familiarity with regulatory submissions such as IND, IMPD, BLA, and MAA, with the ability to contribute to authoring and reviewing content.
• Capable of interpreting complex technical data and preparing clear, concise technical reports for internal and external stakeholders.
• Excellent written and verbal communication skills; detail-oriented and scientifically driven with the ability to present findings to diverse audiences.
• Ability to thrive in a fast-paced, dynamic environment and lead cross-functional teams
• Late stage experience, including process and product characterization, and validation