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

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Senior Manager/Associate Director, Pharmaceutical SciencesTechnical Operations | South San Francisco, CA, United StatesSummary:The Senior Manager, Pharmaceutical Sciences (PS) - Oral Drug Product group will provide hands on experience, strategy and vision to lead and direct Onyx&rsquo;s oral drug delivery, process and formulation development from proof of concept to commercialization. This position will also be responsible for clinical manufacture of Phase 2/3 supplies for Onyx&rsquo;s oral candidate portfolio. This entails design and execution of formulation/process development through internal/external collaborations and coordination of activities between Pharmaceutical Sciences and third party vendors to ensure tech transfer of formulation and process know how in support of Phase 3 production and validation, leading into commercial launch. In addition experience in preparing CMC sections for regulatory submissions globally is required.Key Responsibilities:* Lead the Drug Product Development Team responsible for the oral formulation/process development with associated analytical activities and clinical manufacture in support of advancing Onyx&rsquo;s late stage development candidates.* Create a center of excellence in oral dosage form process and scale-up development.* Lead the screening of a broad range of oral drug delivery systems allowing strategic selection of a platform technology most suitable for development of candidates. (i.e., controlled release delivery systems, novel technologies such as extrusions, solid dispersions etc.). This also includes a regular assessment of externally available technologies and devices that may be used as either development tools or applied to commercial products.* Serve as the subject matter expert to Marketing/Business Development to introduce viable life cycle management product options and/or provide due diligence services.* Ensure development and execution of integrated project plans including milestones, timelines, resources and budgets.* Ensure availability of clinical supplies, timely completion of drug product CMC sections in support of regulatory.* Review, audit and recommend external partners for drug product process development and manufacturing.* Review manufacturing batch records and prepare product development report and other development-related documents.* Create and maintain seamless interaction with other departments including Pharmaceutics, Chemical Process Development, Nonclinical Development, Quality, Regulatory, Clinical, Technical Operations and with external partners. As appropriate, lead multidisciplinary CMC team for designated projects.* Evolve and maintain Onyx knowledge to future industry standards, for example responsible for the design and execution of high quality experimentation leading to the generation of QbD data or enhancing process understanding via the use of process modeling.Minimum Basic Qualifications:* PhD in Pharmaceutics, drug delivery, Chemical engineering or related field.* At least 10 years pharmaceutical industry experience.* Proven ability to execute projects under aggressive timelines.* Responsible for coordinating activities with CRO/CMO management related to Onyx''s development programs.* Possess strong and complex project management experiences.* Strong communicator <<

KEY REQUIREMENTS:

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Not stated