Director CMC Operations

Job not on LinkedIn

March 28

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🔴 Lead

⚙️ Operations

🦅 H1B Visa Sponsor

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Alira Health

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Healthcare Insurance • Consulting

Alira Health is a global consulting firm that partners with life sciences companies to develop innovative solutions in healthcare. The company specializes in a wide range of services including research and clinical development, regulatory compliance, and management consulting. Alira Health focuses on patient engagement, market access, and providing real-world solutions to improve patient outcomes. They are committed to environmental sustainability and actively participate in community involvement and ESG initiatives. Alira Health also provides technology solutions with a focus on improving life sciences research through empathy and scientific excellence.

501 - 1000 employees

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

📋 Description

• Join our global team dedicated to innovation and initiative • Help guide and manage the CMC group • Serve on interdisciplinary client project teams • Collaborate to develop strategies and workflows for bioprocessing • Lead identification of CRO and CDMO partners • Compile, analyze and report results to clients • Perform due diligence on assets for acquisition by clients • Conduct market assessments and portfolio reviews • Draft CMC sections of regulatory submissions • Manage consulting groups and staff • Support sourcing of potential new clients

🎯 Requirements

• BS/MS/PhD in molecular and cell biology, biochemistry or biochemical engineering • 10+ years’ experience in CMC related biologics development and manufacturing roles • Specific, in-depth expertise in manufacturing strategy and operations • Knowledge of biologic manufacturing expression systems • Experience managing CRO/CDMO relationships • Good understanding of FDA, EU, and ICH cGMP guidelines • Experience in successful consulting • Good manager of people • Sound judgment, analytical, problem-solving and decision-making skills • Ability to handle multiple assignments and changing priorities • Demonstrated planning, project management, negotiation, facilitation and presentation skills • Excellent verbal and written communication skills • Proficiency with Microsoft Word, Excel and PowerPoint required

🏖️ Benefits

• salary • bonus • 401k • health benefits • equity in the company