Associate Scientist

Job Title:

Associate Scientist

Job Description

The Associate Scientist supports process development activities within a cleaning characterization group focused on designing and optimizing cleaning processes for both drug substance and drug product manufacturing. This role is fully onsite in Thousand Oaks, CA, and involves hands-on wet laboratory work, experimental design, data analysis, and technical documentation to enable robust cleaning validation and support new product introductions across an internal and external manufacturing network.

Responsibilities

+ Design and perform planned bench-scale experiments to develop and optimize large-scale cleaning processes for biological manufacturing.

+ Develop new methods, apparatus, and procedures for bench-scale characterization and scale-up of cleaning processes, including evaluation of chemistries, temperatures, and contact times.

+ Generate and maintain detailed technical documentation, including technical reports, assessments, procedures, and cleaning evaluation reports.

+ Use characterization data to define key operating parameters (KOPs), testing requirements, and acceptance criteria that support new product launches and cleaning validation studies.

+ Collaborate with Quality, Engineering, and Process Development teams to implement validation requirements at full manufacturing scale.

+ Support investigations of deviations and non-conformances related to cleaning processes and contribute to root-cause analysis and corrective actions.

+ Assist in preparing technical papers and presentations for internal and external publication or communication.

+ Support plant inspections, including regulatory inspections such as pre-approval inspections (PAIs), by providing technical input and documentation related to cleaning processes.

+ Apply good laboratory practices by accurately documenting experimental work, maintaining organized records, and ensuring data integrity.

+ Handle and dispense chemicals, prepare buffers, and operate common laboratory equipment such as pH meters and conductivity meters.

+ Communicate experimental plans, findings, and recommendations clearly in written reports and verbal discussions with cross-functional teams.

Essential Skills

+ Bachelor's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or a related scientific discipline.

+ Approximately 1-2 years of hands-on laboratory experience in an industry, research, or academic setting.

+ Demonstrated wet laboratory experience, including routine bench work and handling of chemicals and solutions.

+ Comfort working in a laboratory environment and adherence to good laboratory practices.

+ Strong attention to detail with the ability to accurately document experiments, observations, and results.

+ Good written and verbal communication skills for reporting data and collaborating with team members.

+ Experience designing and executing bench-scale experiments.

+ Ability to design experiments, handle instruments, and perform technical report writing.

+ Master's degree and 2 years of scientific experience, or Bachelor's degree and 4 years of scientific experience, for consideration at the higher experience tier.

Additional

Skills & Qualifications

+

Experience with analytical methods such as Total Organic Carbon (TOC), protein assays, gel electrophoresis, and spectroscopic techniques.

+ Background in characterization and validation of processes for biological products.

+ Good working knowledge of scientific principles, methodologies, and practices relevant to process development and cleaning characterization.

+ Familiarity with laboratory methods including handling and dispensing chemicals, preparing buffers, and operating pH and conductivity meters.

+ Strong interpersonal skills and the ability to work effectively within cross-functional teams.

+ Ability to write clear technical papers, reports, and procedures for internal and external audiences.

+ Interest in biotechnology and therapeutic development, particularly in areas of high unmet medical need.

+ Alignment with a mission-driven environment focused on improving health outcomes and patients' lives through innovative human therapeutics.

Work Environment

This role is based 100% onsite at a corporate headquarters in Thousand Oaks, CA, working in a laboratory environment that supports process development for biological manufacturing. The schedule typically follows a Monday-Friday workweek, with standard daytime hours around 8:00 AM to late afternoon or early evening. The environment emphasizes good laboratory practices, safe handling of chemicals, and careful operation of common lab equipment such as pH and conductivity meters and analytical instruments used for TOC, protein assays, electrophoresis, and spectroscopic methods.

Work is highly collaborative, involving close interaction with Quality, Engineering, and Process Development teams, as well as participation in investigations and plant inspections. The broader organizational culture focuses on unlocking the…