Senior Project Manager, Technical Operations
San Diego, CA - USA
Job Summary
Department:
106800 Technical OperationsLocation:
San Diego USA- RemoteBe 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 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:
- Bachelors 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 Traveres 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:
$132000.00 - $172000.00*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 candidates 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 . 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.
Required Experience:
Senior IC
About Company
Travere Therapeutics is a biopharmaceutical company whose mission is to identify, develop and deliver life-changing therapies to people living with rare disease.