Position Summary:
The Senior Project Manager, Technical Operations (CMC) is responsible for driving the execution of Technical Operations strategies that support product development, clinical manufacturing, commercial launch planning, logistic, and lifecycle management.
This individual partners closely with Quality, Regulatory Affairs, Supply Chain, and Clinical Supply to ensure alignment, risk management, and successful achievement of program milestones. The successful candidate will have substantial experience supporting biologic development programs and drive CMC strategy for a late stage development asset.
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.
Education/Experience Requirements:
- 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
- MS, MBA, PhD, PharmD, or other advanced degree in a related discipline preferred
- 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
- Experience supporting Biologics License Application (BLA) submissions and post-approval commitments is preferred
- Familiarity with GMP regulations, quality systems, and biologics manufacturing operations
- Knowledge of process validation, technology transfer, and commercial manufacturing operations for biologics
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
- 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)
- PMP (Project Management Professional) certification preferred
- 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
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:**
$132,000.00 - $172,000.00
*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 accommodations@travere.com. 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.
