Senior Project Manager, Technical Operations
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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
Benefits
Additional Information
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 . 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.
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