Senior Project Manager, Technical Operations

RETROPHIN, INC.

SALT LAKE CITY, UT

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JOB DETAILS

SKILLS

Biochemistry, Biology, Biotech and Pharmaceutical, Business Administration, Business Strategy, Calendar Management, Chemical Engineering, Chemistry, Communication Skills, Cross-Functional, Disease, Drug Development, Drug Manufacturing, Drug Products, Forecasting, GMP (Good Manufacturing Practices), Inventory Management, Logistics Management, Manufacturing, Manufacturing Management, Manufacturing Systems, Medical Products, Meeting Minutes, Operational Improvement, Operational Strategy, Product Development, Product Support, Product/Service Launch, Production Schedule, Production Support, Project Planning, Project Tracking, Project/Program Management, Regulations, Risk Analysis, Risk Management, Software Administration, Supply Chain, Team Player, Technical Delivery, Technical Operations, Technical Strategy, Technical Writing, Time Management

LOCATION

SALT LAKE CITY, UT

POSTED

2 days ago

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

About the Company

RETROPHIN, INC.

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