Associate Director, Commercial Manufacturing & Packaging
Travere Therapeutics
Summary
The Associate Director, Commercial Manufacturing is accountable for the strategy, oversight, and execution of commercial drug product manufacturing and packaging activities across Travere's external manufacturing network. This role leads manufacturing planning, CMO governance, process validation, technology transfer, operational performance, and supply-risk management to ensure a reliable, compliant, and uninterrupted supply of commercial products. The Associate Director partners with Supply Chain, Quality, Regulatory Affairs, Technical Operations, and Commercial stakeholders to translate business forecasts and product strategies into executable manufacturing plans and to provide senior management with recommendations regarding capacity, resources, risk, and external manufacturing strategy.
Job description
Responsibilities
- Direct and coordinate manufacturing activities at CMOs for commercial drug products to ensure uninterrupted market supply.
- Establish and maintain manufacturing schedules based on internal sales forecasts and Sales & Operations Planning meeting decisions; assess capacity, inventory, and supply risks and lead the development of mitigation and contingency plans.
- Verify suitability, qualification and validation of processes at Contract Manufacturing Organizations (CMO) for drug product.
- Provide manufacturing support, troubleshooting, on internal and external project teams.
- Maintains up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical drug product manufacturing and packaging.
- Represent commercial manufacturing for technical due diligence, CMO selection, qualification, contracting support, and manufacturing-network strategy.
- Author/edit technical reports on a variety of manufacturing-related subjects as needed.
- Assist management during regulatory inspections and internal, and external audits.
- Assist with the development of CMC sections of regulatory submissions.
- Additional duties assigned as needed.
Education/Experience Requirements
- Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline required. Equivalent combination of education and applicable job experience may be considered.
- 8+ years of progressive experience directly leading pharmaceutical manufacturing and packaging shop floor activities including process troubleshooting and optimization activities required.
- Manufacturing experience with multiple dosage forms desired, including oral solid dosage forms.
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.
- Expert knowledge in process validation and technology transfer procedures.
- Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
- Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills.
- 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.
Requirements
- Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline required
- 8+ years of progressive experience directly leading pharmaceutical manufacturing and packaging shop floor activities including process troubleshooting and optimization activities required
- Manufacturing experience with multiple dosage forms desired, including oral solid dosage forms
- Expert knowledge in process validation and technology transfer procedures
- Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills
- Excellent decision-making and collaboration skills with strong attention to detail
- Ability to travel 10% domestically and internationally
Benefits
- Health insurance
- Life insurance
- Disability insurance
- Retirement plans
- Employer match
- Paid time off
- Wellness programs
- Employee support programs
Company overview
Travere Therapeutics is a biopharmaceutical company headquartered in San Diego, California, dedicated to identifying, developing, and delivering life-changing therapies for people living with rare kidney and metabolic diseases. Founded in 2011 as Retrophin and rebranded as Travere Therapeutics in 2020, the company has established itself as a leader in rare disease therapeutics with a focused pipeline targeting conditions with significant unmet medical needs. Their flagship product, FILSPARI® (sparsentan), received full FDA approval in September 2024 to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk for disease progression. The company also has a Phase 3 clinical program for pegtibatinase (TVT-058) targeting classical homocystinuria (HCU), a rare genetic metabolic disorder. Travere maintains a commercial portfolio including Thiola EC® and Thiola® for cystinuria, demonstrating their commitment to serving rare disease communities through comprehensive therapeutic solutions. With a global presence and strategic partnerships, Travere Therapeutics continues to advance innovative treatments while supporting patient access and education initiatives for rare disease populations.