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Job Field: Office Jobs
Location: South San Francisco, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Scientist I, Pharmaceutical SciencesTechnical Operations | South San Francisco, CA, United StatesSummary: The candidate must have the knowhow and the experience in process development and lyophilization cycle development for parenteral drug products. The position will monitor manufacturing processes and analyze the trend of the manufacturing process parameters for operations carried out a CMO. The candidate will conduct study design by DOE and/or develop process models in order to facilitate tech transfer and optimize manufacturing processes. The candidate is expected to be proficient in the use of lab instruments and equipment for HPLC, Karl Fisher determination, freeze drying microscopy, DSC, pilot scale mixing and pilot scale lyophilization. The position requires preparing oral presentations, written protocols and reports.Essential/Primary Duties, Functions and Responsibilities: Under the supervision of a Senior Scientist* Developing lyophilization cycles and preparing research stability batches.* Developing processes and designing pilot scale equipment for compounding poorly soluble compounds* Utilizing DOE and/or other process models to design full scale operations* Working with contract organizations to monitor the manufacturing process, manage deviations and investigations, analyze the trend of the manufacturing process, and trouble-shoot technical operations.* Presenting results at the internal team meetings.* Investigating new technologies and innovating operations for novel drug formatsRequirementsWork Experience:* BS/MS with 8-12 years or PhD with 0-2 year experience in pharmaceutical industry, or related fields.Management of Staff:* Could manage Research Associate* Could manage CMOFunctional/Technical Knowledge & Skills: * Knowledgeable in operation of HPLC, Karl-Fischer and other related analytical instruments.* Experience in operating, programing, and maintaining pilot scale lyophilizer. * It is desirable to have some knowledge of GMP and hands-on GMP experience.* Ability to draft scientific reports.* Strong and independent problem-solving and troubleshooting abilities.* Experience in conducting DoE for process development, scale up and tech transfer. Customer & Industry Knowledge:* Some experience in pharmaceutical manufacturing and operations. Familiar with cGMP and GLP principles.Education/Training:* BA/BS/MS with 8-12 years experience in pharmaceutical sciences, chemical engineering, or related education.* PhD with 0-2 year experience in pharmaceutical sciences, or pharmaceutics.Other Requirements: * Good team player that is able to work well within and across teams to achieve common goals.* Proficient in presenting data and results in group setting. * Flexible and can accommodate demanding work schedule as required. * Has the ability to prioritize multiple tasks. * Experienced in writing scientific reports.* Excellent oral and written communication skillsCompetencies:* Familiar with PC and associated productivity suite of software (Microsoft Word, Excel, PowerPoint etc).<<

KEY REQUIREMENTS:

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Not stated