Associate Director, Technical Operations (Analytical Development-Biologics)

Travere Therapeutics; Columbia (SC); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Stock options

Paid time off

Job summary

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations to lead analytical method development, validation and transfer for a biologics product in a fast-paced, regulated environment.

This role requires 8+ years in analytical development of biologics, hands-on expertise with HPLC, CE-SDS, cIEF, LC-MS, and strong collaboration with CDMOs/CROs, Quality and Regulatory teams.

Qualifications

• B.S. in chemistry, biochemistry, pharmaceutical science or related Life Sciences discipline required. M.S. preferred.
• 8+ years of analytical development experience in biologics, preferably late-stage.
• Direct knowledge of HPLC, CE-SDS, cIEF, ELISA, LC-MS and related methods.

Responsibilities

• Manage 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 batch records and CoAs.
• Assist in OOS and OOT investigations with root cause analyses.
• Contribute to regulatory submissions with analytical packaging info.
• Provide scientific/technical support to ensure compliant manufacturing and release.
• Perform additional duties as needed.

Skills

HPLC

CE-SDS

cIEF

potency bioassays

peptide map

ELISA

LC-MS

Education

B.S. in chemistry/biochemistry/pharmaceutical science

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 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 [e-mail]. 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.