Senior Scientist, Drug​/Device Combination Products

Senior Scientist – Container Closure Integrity Development

Join our Company's Device Product & Process Development (DPPD) Team, which focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products. In this role, the Senior Scientist will lead container closure integrity (CCI) technology development, including method development, validation, and testing for vials, syringes, cartridges, injectors, and secondary packaging.

• Serve as an analytical subject matter expert (SME) in CCI methods, troubleshooting and optimizing analytical methods.
• Build, mentor, and train laboratory staff and users to ensure proper execution of test methods, adherence to procedures, and consistent data quality.
• Develop, validate, and execute feasibility CCI studies for complex combination devices and delivery systems.
• Author technical reports and testing protocols.
• Collaborate with cross‑functional teams to ensure successful transfer of analytical methods between QC labs.
• Demonstrate excellent communication, prioritization, presentation, negotiation, project management, and organizational skills.
• Work independently as a self‑motivated professional.
• Apply laboratory good documentation practices and electronic documentation systems.
• Apply knowledge of analytical test method technology transfer process.
• Travel as required (~10%).

• B.S./M.S. in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related discipline, with 4‑8 years of relevant experience in pharmaceutical, biotechnology, or medical device industries.
• Ph.D. in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, or Pharmaceutical Sciences.

• Relevant analytical execution, development, validation, and/or quality‑control (QC) for container closure integrity for small molecule, biologics, and vaccine products.
• Ability to learn new techniques, troubleshoot assays, and author and review technical documents.
• Excellent organizational skills to manage multiple projects.

• cGMP experience.
• Hands‑on experience in CCIT method development, validation, and troubleshooting for injectable therapeutics, familiar with dye ingress, high‑voltage leak detection, vacuum and pressure decay, laser headspace analysis.
• Fluency with industry‑related guidance USP and ISO‑13485.
• Good technical, communication (oral and written), interpersonal, and teamwork skills.
• Ability to effectively identify and communicate risks.
• Experience with other analytical methodologies.

Approximately 10% travel.

$ – $ (annually).

Comprehensive package including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days.

San Francisco, CA Resident Only. Qualified applicants with arrest and conviction records may be considered in compliance with the San Francisco Fair Chance Ordinance. Los Angeles, CA Resident Only, qualified applicants with criminal histories are considered per the City of Los Angeles Fair Chance Initiative.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

We embrace diversity and inclusivity in the workplace.