Associate Principle Scientist

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Job description

Yoh is seeking an Associate Principle Scientist to support our Biopharmaceutical client in the San Francisco Bay Area. In this position you will be responsible for aspects of development, characterization, scale up, and transfer of the manufacturing process for a localized delivery technology platform. Reporting to the Director of Process Development, this position requires an independent and creative thinker able to work with internal and external groups in support of process development and manufacturing objectives.

Key Responsibilities

• Oversees the design, scale-up and implementation of manufacturing processes, instruments, and equipment from the laboratory through pilot and manufacturing scales
• Manage efforts at CMOs for GMP manufacture of development products, including polymer-based hydrogels, drug conjugates, and drug product
• Support drug product activities, such as freeze thawing, filling, lyophilization, inspection and packaging/shipment
• Oversee activities contributing to process characterization and validation efforts
• Work with analytical team to assist in the development and optimization of hydrogel and drug substance processes. Collaborate with drug product experts on formulation and lyophilization parameters, selection of primary containers, and other activities relevant to the end-to-end manufacturing process
• Design and execute experiments to optimize and characterize key process operations, and develop in-process controls for products under development using our novel delivery platform
• Assist in the authoring and support of CMC regulatory filings and health authority interactions
• Foster collaborations across sites
• Work on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods and techniques
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
• Other responsibilities as required according to corporate strategy or group needs

Knowledge, Skills and Experience

• Minimum Bachelor's degree (Master's degree preferred) in Chemical Engineering, Chemistry, Biochemistry, or related field.
• Minimum of 8 years of experience in the Biotech or Pharmaceutical Industry, preferably in Process Development / Manufacturing Science and Technology / Formulation or Analytical Development at leading pharmaceutical or biotech companies
• Experience in some of the following areas is desired: purification processes, conjugation/ADC, aseptic processing, polymer handling, hydrogels, handling of highly potent substances
• Strong hands-on expertise in process optimization, characterization and development, from early to commercial stage
• Expertise in cGMP, regulatory and quality requirements of drug substance and/or parenteral drug manufacturing
• Experience in equipment design preferred (tanks, fittings, custom assemblies, disposables, typical biotechnology processing equipment)
• Expertise in complex technology transfers
• Prior experience working with CMOs preferred
• Pro-active, collaborator and communicator, with a solid understanding of drug development and an ability to plan and conduct work with little guidance
• Strong team player with an open mindset, that thrives in global collaborations

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