Senior Project Manager, Technical Operations

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $132k - $172k / year

⏰ Full Time

🟠 Senior

🤓 Technical Project Manager

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Travere Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Travere Therapeutics is a biopharmaceutical company committed to identifying, developing, and delivering life-changing therapies for people living with rare diseases, particularly those related to rare kidney and metabolic disorders. The company has a strong focus on advancing science in these fields, with a pipeline that includes treatments for conditions such as IgA nephropathy and focal segmental glomerulosclerosis. With the full U. S. FDA approval of its non-immunosuppressive treatment for IgA nephropathy, Travere Therapeutics continues to set new standards of care. The company collaborates with the rare kidney disease community, including patient advocacy organizations and clinical trial investigators, to bring hope to patients with these serious conditions.

📋 Description

• 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.

🎯 Requirements

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

🏖️ Benefits

• premium health • financial offerings • work-life and well-being offerings for eligible employees and dependents • wellness and employee support programs • life insurance • disability • retirement plans with employer match • generous paid time off