Director, Biologics CMC Technical Writing

Travere Therapeutics; San Diego (CA); Presencial; USD 189 000 - 246 000; Tempo integral

Resumo da oferta

Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) in San Diego. You will lead the preparation of CMC documentation for regulatory submissions, including BLA, and drive the strategy and execution of Module 3 content for biologics products.

The role requires extensive CTD experience, collaboration across Regulatory Affairs, QA, Manufacturing, and external partners, and strong scientific writing abilities.

Qualificações

• 10+ years in pharma/biotech with CTD Module 2/3 experience.
• Direct experience authoring CTD Module 2 and Module 3 content for BLA or similar submission.
• Experience with biologics development, manufacturing, and regulatory sciences.

Responsabilidades

• Lead the planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
• Coordinate sections covering drug substance/product manufacturing, process development, validation, and control strategies.
• Prepare and align Module 3 content with QA, regulatory, and governance requirements.
• Collaborate with regulatory affairs, SMEs, and external partners to resolve content gaps.
• Prepare governance presentations and regulatory responses as needed.
• Manage document reviews, version control, and approval workflows.

Conhecimentos

Regulatory writing

Cross-functional collaboration

Regulatory strategy

Strong writing skills

PowerPoint presentations

Attention to detail

Formação académica

Bachelor's degree in pharmaceutical sciences/related field

MS/PhD preferred

Ferramentas

Microsoft PowerPoint

eCTD tools

Descrição da oferta de emprego

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. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow.

Position Summary

The Director, Technical Operations (Biologics CMC Technical Writing) is responsible for the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions, including Biologics License Application (BLA). This individual leads the development and execution of the CMC submission strategy in collaboration with Regulatory Affairs and technical subject matter experts (SME) and directs the preparation of high-quality, scientifically rigorous content that clearly communicates the product’s development history, manufacturing process, control strategy, and commercial readiness. The ideal candidate has extensive experience authoring Module 3 content for biologics products, with particular expertise in drug substance production. This role requires strong scientific judgment, excellent writing skills, and the ability to influence and drive decisions across technical SMEs, Regulatory Affairs, Quality, Manufacturing, Project Management, and external partners. The Director serves as the Technical Operations leader for CMC content integration, advises governance on submission readiness and material risks, and drives timely resolution of technical or content gaps supporting the corporate goals for development and commercialization of a combination product for a rare disease indication.

Responsibilities

• Lead the planning, authoring, and delivery of CMC content for the regulatory submissions such as the BLA, including relevant CTD Module 2 summaries and Module 3 sections.
• Translate complex technical data into clear, concise, accurate, and regulator-ready narratives.
• Develop document strategies, content plans, timelines, templates, and authoring standards for the CMC submission.
• Author and coordinate sections covering: Drug substance and drug product manufacturing processes
• Process development, characterization, validation, and control strategies
• Microbial fermentation and downstream purification
• Product and process characterization
• Specifications, analytical procedures, and method validation
• Formulation and lyophilization development
• Container closure systems
• Stability programs and proposed shelf life
• Manufacturing comparability and lifecycle changes
• Ensure consistency across Module 3 sections and alignment with the Quality Overall Summary, regulatory strategy, source reports, and supporting data.
• Lead cross-functional authoring and decision-making forums, reconcile differing technical perspectives, establish key regulatory messages, and drive timely resolution of technical and content gaps.
• Identify submission risks, data gaps, inconsistencies, and potential regulatory questions early in the authoring process.
• Manage document reviews, comment resolution, version control, and approval workflows.
• Support responses to FDA information requests and other regulatory questions during BLA review.
• Collaborate with internal teams, contract manufacturers, testing laboratories, consultants, and other external partners.
• Prepare clear and effective PowerPoint presentations for governance meetings, regulatory interactions, technical reviews, and executive updates.
• Establish sustainable CMC authoring best practices.
• Additional duties as needed.

Education/Experience Requirements

• Bachelor’s degree in pharmaceutical sciences, chemical engineering, biotechnology, or a related discipline required.
• Equivalent combination of education and applicable job experience may be considered.
• M.S. or Ph.D. or other relevant advanced degree preferred.
• 10+ years of progressively relevant pharmaceutical or biotechnology industry experience required.
• Direct experience authoring CTD Module 2 and Module 3 content for at least one BLA, marketing application, or comparable late-stage biologics submission.
• Strong working experience with microbial fermentation, recombinant proteins, or bacterial expression systems required.
• Experience with lyophilized drug product, combination products, and device constituent components is highly desirable.
• Strong knowledge of biologics development, manufacturing, analytical control, process validation, scale up, comparability, stability, and commercial manufacturing.

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. Experience participating in FDA meetings, BLA review activities, regulatory information requests, or pre-approval inspections. Experience with delivery systems, design controls, human factors activities, and device related risk management. Advanced PowerPoint skills and experience preparing technical, regulatory, governance, and executive level presentations Strategic thinker and strong cross functional collaborator Clear and persuasive scientific communicator Skilled at driving content decisions within a matrixed organization and managing compressed timelines with strong attention to detail Committed to quality, accuracy, consistency, and regulatory compliance Excellent decision-making and collaboration skills with strong attention to detail Ability to travel 10% 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. 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: $189,000.00 - $246,000.00 *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.

Travel

Ability to travel 10% 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.

EEO/AA/Veteran/Disability Employer

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.

Contact/Information

For more information, visit travere.com.