Director, Biologics CMC Technical Writing

Planet Pharma; San Diego (CA); On-site; USD 189,000 - 246,000; Full time

Benefits offered by this job

New Hire Equity grant

Job summary

Travere Therapeutics in San Diego seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead CTD Module 2 and Module 3 authoring for BLA submissions. You will oversee cross-functional teams, develop submission strategies, and deliver regulator-ready narratives that summarize manufacturing, controls, and product characterization.

Ideal candidate has 10+ years in pharma/biotech, strong writing, and extensive biologics experience, including fermentation and downstream

Qualifications

• Bachelor’s degree in pharmaceutical sciences or related field; equivalent experience may be considered.
• MS/PhD or other advanced degree preferred for seniority.
• 10+ years of pharmaceutical/biotech experience; CTD Module 2/3 authoring for BLA or equivalent.
• Experience with biologics development, fermentation, and downstream processing.

Responsibilities

• Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
• Coordinate sections including drug substance/product manufacturing, process development, and validation.
• Prepare regulator-ready narratives; ensure consistency across Module 3 and alignment with regulatory strategy.
• Lead cross-functional forums, resolve technical gaps, manage reviews and approvals.
• Prepare governance presentations for regulatory interactions and executive updates.

Skills

CMC writing

Cross-functional leadership

Regulatory submissions

Regulatory strategy

PowerPoint expertise

Education

Bachelor’s degree in pharmaceutical sciences

Ms/PhD preferred

Tools

PowerPoint

Job description

Intake call being scheduled
HM –https://www.linkedin.com/in/pattihaller/
Strong preference to local candidates

*Benefits and Travere Recruiting Deck noted in files section

*Resumes with no logo and full contact info (LI/P/E/City, State), summary in notes

Please notethat the base salary ranges may vary for positions that require an MD or JD degree. The salary ranges provided apply to roles that donotrequire an MD or JD. Additionally, the New Hire Equity grant is a one-time award provided to new hires and vests over a four-year schedule. We can schedule time to go over the equity piece as well in detail.

Department –Clinical Development

Location, San Diego, CA –For positions listed as San Diego/Remote, our preference is for candidates who are based in the San Diego area. Those employees would typically work in ahybridarrangement, coming into the officetwo days per week, withTuesdays and Wednesdaysgenerally being the preferred in-office days (although this may vary slightly by team).

Target Base Pay Range

$189-246

• Bonus: 25%
• New Hire Equity: 6000 RSU (Restricted Stock Units)

Department –Technical Operations

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 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