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Partner with CMC and Quality teams to bolster cGMP manufacturing. A Biopharmaceutical company is looking to hire a Director of Formulation to help lead a team focused on developing innovative dosages forms and delivery systems.
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Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development, and Manufacturing. You will provide expertise for the scale-up, tech transfer, and validation of upstream cell culture and viral vector unit operations in support of clinical/commercial manufacturing.
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Supervise formulation scientists and technicians and ensure their activities comply with company, departmental and cGMP regulations. Serve as a technical representative and the lead formulation scientist on cross-functional project teams.
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5-10 years' experience leading and managing cGMP manufacturing (aspetic clean rooms including formulation, filling, and inspection and packaging) and materials management (warehouse & shipping.
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The Manufacturing Supervisor uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.
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Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Technician I. The Manufacturing Technician I will be responsible for conducting cGMP manufacturing of solid oral and liquid oral pharmaceutical dosage forms for Phase I and Phase II clinical trials.
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Working knowledge of cGMP and USDA requirements for Vaccine Manufacturing. Working knowledge of cGMP and USDA requirements for Vaccine Manufacturing. Preferred Biology Degree or related field from an accredited institution, two years or more (2+) of laboratory experience and/or manufacturing experience.
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Ensuring that processes are suitable for controlling the quality of API as required by cGMP, ICH and FDA regulations as well as the attributes conducive to successful formulation development.
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Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design.
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As an Analytical Chemistry Scientist II Reagent Development Services – Analytical Method Development and Transfer Group, you will work in a dynamic, team-oriented environment, collaborating with internal and external partners to develop, validate and, transfer analytical methods to support formulation development, stability testing, and quality control testing of raw materials, intermediates, and final products in accordance with project timelines.
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As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry.
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Adhere to cGMP, SOP, and site safety procedures in order to operate, assemble, disassemble, and clean essential pharmaceutical manufacturing and testing equipment. Formulation Process Operator.
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The Principal/Sr. Scientist leads the development of Controlled Release Dosage Forms, from pre-formulation to formulation, aligning with scientific standards and IP strategies. Utilize statistical analysis for data interpretation; manage cGMP production oversight.
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This position is responsible for the performance of pharmaceutical formulation process development activities; authors supporting process documentation (URS, SOPs, Change Control, EAF, ETOP, etc.
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Perform and train other employees in various manufacturing tasks, including, but not limited to: Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability, and Sterile Filling.
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