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Bioassay Development Jobs in California (NOW HIRING)

BioLegend

Quality Control Associate

San Diego, CA

... bioassays. This position will also perform all aspects of the assays following SOPs and ISO ... Transform - Adapt, learn, re-invent and change for future development and growth Minimum ...

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Bioassay Development information

What is bioassay development?

Bioassay development is the process of designing, optimizing, and validating biological tests (bioassays) that measure the potency, purity, or biological activity of a substance, such as a drug, vaccine, or biologic. These assays are crucial in pharmaceutical and biotechnology industries for quality control, regulatory approval, and research. The process involves selecting the appropriate biological system, establishing assay conditions, and ensuring reproducibility and accuracy of results.

What are some typical challenges faced during bioassay development, and how are they addressed within a team setting?

A common challenge in bioassay development is ensuring assay reproducibility and robustness across different batches and operators. Teams often address this by conducting thorough validation studies, standardizing protocols, and encouraging open communication to troubleshoot issues quickly. Collaboration between scientists, statisticians, and quality control personnel is essential to optimize assay conditions and interpret data accurately. Regular team meetings and documentation help keep everyone aligned and maintain high assay performance standards.

What are the key skills and qualifications needed to thrive as a bioassay development scientist, and why are they important?

To thrive as a Bioassay Development Scientist, you need a strong background in molecular biology, biochemistry, and analytical techniques, typically supported by a degree in life sciences or a related field. Familiarity with laboratory automation, data analysis software (such as GraphPad Prism or SoftMax Pro), and regulatory guidelines like GLP/GMP is essential. Attention to detail, critical thinking, and strong collaboration skills help you design robust assays and solve complex problems effectively. These competencies are vital for generating reliable data, ensuring compliance, and advancing drug discovery or quality control processes.
What are popular job titles related to Bioassay Development jobs in California? For Bioassay Development jobs in California, the most frequently searched job titles are:
What job categories do people searching Bioassay Development jobs in California look for? The top searched job categories for Bioassay Development jobs in California are:
Bioassay Development jobs near you
Infographic showing various Bioassay Development job openings in California as of July 2026, with employment types broken down into 1% As Needed, 78% Full Time, 17% Part Time, 1% Temporary, and 3% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

Associate Director, Technical Operations (Analytical Development-Biologics)

Travere Therapeutics

San Diego, CA • On-site

Full-time

Medical, Life, Retirement, PTO

Posted 9 days ago

Job description

Department:
106800 Technical Operations
Location:
San Diego, USA- Remote
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
Position Summary:
The Associate Director, Technical Operations is responsible for the analytical operations of a biologics product and serves as an analytical subject matter expert for Travere. This position is responsible for analytical method development, validation, and transfer in compliance with cGMP and international regulatory standards. The candidate must have extensive knowledge of FDA, ICH and EU regulatory requirements and have the ability to work effectively in a virtual environment. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory, supporting the corporate goals for clinical development to commercialization of a biologics drug product for a rare disease indication.
Responsibilities:
  • Manage and oversee method development, validation, and transfer for biologics products at CDMOs/CROs.
  • Oversee specification setting of drug substance and drug product at CDMOs/CROs.
  • Author/review analytical method validation protocol/report, method transfer protocol/report and SOPs.
  • Manage reference standard program for drug substance and drug product.
  • Review controlled documents such as batch records and CoAs.
  • Assist in OOS and OOT investigations. Perform root cause analyses and recommend corrective actions.
  • Contribute and act as the technical subject matter expert in preparation of regulatory submissions related to drug substance and drug product analytical package, characterization, reference standard.
  • Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations.
  • Additional duties assigned as needed.

Education/Experience Requirements:
  • B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences discipline required. M.S. degree preferred. Equivalent combination of education and applicable job experience may be considered.
  • 8+ years of relevant experience in analytical development of biologics, preferably in late-stage drug development.
  • Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical methods. Experience with PEGylated and/or lyophilized products is a plus.
  • Extensive analytical development, validation and transfer background with experience reviewing analytical data and managing analytical development activities at external CDMOs/CROs.

Additional Skills/Experience:
  • The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
  • Driven, intelligent, passionate about making a difference for patients with rare diseases.
  • Strong professional experience in a similar role within the pharmaceutical industry.
  • Maintain up-to-date knowledge of US and EU GMPs, USP, Ph. Eur, and ICH guidelines as applicable to cGMP manufacturing and control of drug substance and drug product.
  • Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
  • Proven ability to create and manage complex project plans, timelines, budgets, and critical path tasks.
  • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
  • Ability to travel 10-20% domestically and internationally.
  • All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$150,000.00 - $195,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.

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