Associate Director, Technical Operations (Analytical Development-Biologics)

Travere Therapeutics; United States; On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Retirement plans with employer match

Generous paid time off

Stock-based incentive

Job summary

Travere Therapeutics is seeking an Associate Director, Technical Operations to lead analytical operations for a biologics product. You will develop, validate, and transfer analytical methods, ensuring cGMP compliance and alignment with FDA/ICH/EU standards.

The role collaborates with Quality, Regulatory and Tech Ops teams to enable development through commercialization of therapies for rare diseases. The position requires strong scientific leadership, experience with external CDMOs/CROs, and the

Qualifications

• BS degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences; MS preferred.
• 8+ years of analytical development experience for biologics.
• Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide mapping, ELISA, LC-MS.
• Experience with PEGylated and/or lyophilized products is a plus.
• Extensive development, validation, and transfer with CDMOs/CROs.

Responsibilities

• Manage method development, validation, and transfer for biologics.
• Oversee drug substance/product specifications at CDMOs/CROs.
• Author/review validation/transfer protocols and SOPs.
• Manage reference standard program for drug substance/product.
• Review batch records and CoAs.
• Assist in OOS/oot investigations and root-cause analyses.
• Support regulatory submissions with analytical data.
• Provide technical support to internal/external teams for compliance.
• Additional duties as needed.

Skills

Analytical development

HPLC

CE-SDS

cIEF

Potency bioassays

Peptide mapping

ELISA

LC-MS

Lyophilized products

Education

B.S. in chemistry/biochemistry/pharmaceutical science or related Life Sciences

M.S. preferred

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 Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.