Senior Project Manager, Technical Operations

Travere Therapeutics; San Diego (CA); Sur place; USD 132 000 - 172 000; Plein temps

Résumé du poste

Travere Therapeutics seeks a Senior Project Manager in Technical Operations to drive CMC strategy for biologics programs, ensuring alignment with product development, clinical manufacturing, and lifecycle management. You will partner across Quality, Regulatory, Supply Chain, and Clinical Supply to reach milestones.

The role requires 7+ years in biotech/pharma, with 4+ years in PM for CMC/Manufacturing, and familiarity with GMP and process validation.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, or a related discipline required.

Responsabilités

• 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.

Connaissances

Project planning

Risk management

Stakeholder management

Communication skills

Leadership

Biologics/CMC knowledge

Formation

Bachelor's in Life Sciences

Advanced degree (MS/PhD/MBA/PharmD)

Outils

Smartsheet

MS Project

PMP certification

Description du poste

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.

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 [e-mail]. 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.

At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com.