Note: The job is a remote job and is open to candidates in USA. Travere Therapeutics is a biopharmaceutical company focused on developing life-changing therapies for rare diseases. The Senior Project Manager, Technical Operations will drive the execution of strategies supporting product development and lifecycle management, collaborating closely with various departments to ensure project success.
Responsibilities
- Execute CMC strategies aligned with corporate objectives for biologics program(s)
- Develop and maintain integrated project plans, timelines, and resource forecasts
- Ensure effective communication of project status, risks, and opportunities; improve operational efficiency
- Facilitate team meetings, prepare agenda, publish meeting minutes, and ensure accountability for deliverables
- Monitor project progress and proactively identify, assess, and mitigate risks
- Coordinate CMC initiatives and activities, and partner with cross-functional teams to ensure readiness and timely delivery of technical documentation and regulatory commitments, and other CMC deliverables
- Align with internal and external stakeholders to support production schedules, supply planning, and inventory management to ensure uninterrupted product availability
- Additional duties assigned as needed
Skills
- Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, or a related discipline required. Equivalent combination of education and applicable job experience may be considered
- 7+ years of relevant experience in biotechnology, pharmaceutical development, manufacturing, or technical operations
- 4+ years of project management experience supporting CMC, Technical Operations, Manufacturing, or Product Development programs
- Direct experience supporting biologic drug products, including CMC development, manufacturing, and lifecycle management activities
- Demonstrated experience managing complex cross-functional projects through clinical development and commercialization
- Familiarity with GMP regulations, quality systems, and biologics manufacturing operations
- Knowledge of process validation, technology transfer, and commercial manufacturing operations for biologics
- Exceptional project planning, risk management, and stakeholder management skills
- Excellent communication and executive presentation abilities
- Proficiency with project management tools (e.g., Smartsheet, MS Project)
- Successful record of creating and managing complex project plans, timelines, 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
- MS, MBA, PhD, PharmD, or other advanced degree in a related discipline
- Experience supporting Biologics License Application (BLA) submissions and post-approval commitments
- PMP (Project Management Professional) certification
Benefits
- 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
- Generous paid time off
- Short-term incentive (cash compensation)
- Long-term incentive compensation (company stock)
Company Overview
Company H1B Sponsorship