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Senior Project Manager, Technical Operations

RETROPHIN, INC.

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At a glance

Compensation
No compensation found
Location
Remote · US
Work Authorization
Not specified

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Job overview

The Senior Project Manager, Technical Operations (CMC) drives Technical Operations strategies supporting product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management. The role partners with Quality, Regulatory Affairs, Supply Chain, and Clinical Supply to align work, manage risks, and achieve program milestones. The successful candidate will have substantial experience supporting biologic development programs and drive CMC strategy for a late-stage development asset.

Skills & qualifications

RequiredNice to have

Skills

CMC StrategyBiologic Drug ProductsCMC DevelopmentBiologics ManufacturingLifecycle ManagementCross-Functional Project ManagementBLA SubmissionsGMP RegulationsQuality Systems

Qualifications

Bachelor's in Life Sciences or RelatedAdvanced Related Degree7+ Years Relevant Experience4+ Years CMC Project Management

Full job description

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 regulati ons, quality systems, and biologics manufacturing... For full info follow application link. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer

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