Director - Phase 1 Manufacturing
SRI International - Menlo Park, CA

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Job Description

SRI International is seeking a Director of Pharmaceutical Development to lead its growing cGMP clinical dosage program. SRI's pharmaceutical formulation facility is designed for manufacture of Phase I/II investigational drug products including capsules, tablets, semisolids, and parenterals. The successful candidate will develop, plan, and implement dosage preparation and packaging processes and technical operations. Manufacturing processes will be transferred from internal formulation R&D and GLP studies, and sponsors or arise from self-designed pilot studies. This is a unique opportunity to contribute at the interface of formulation development and first-in-man studies.

The successful candidate will ensure the pharmaceutical development team meets client technical, quality, financial, and timeline specifications. This individual will direct manufacturing technicians; coordinate with other internal team members in formulations, quality control, and quality assurance; and keep project management and clients apprised of progress and issues. The Director will prepare/oversee the preparation of SOPs, protocols/reports, and batch records and will manage the calibration and maintenance of the facility and associated equipment. The Director will contribute to strategic planning and business development activities.

Requirements:
Ph.D. in pharmaceutics, chemistry, chemical engineering, PharmD, or a related field with minimum of 10 years relevant, progressively responsible experience in the pharmaceutical industry, including at least 5 years of cGMP regulated activities. Exceptional M.S. candidates with demonstrated capabilities may be considered.

Strong scientific knowledge of solid dosage form processes such as granulation, milling, tableting, and coating. Excellent oral and written communication skills required. Previous contract organization or GLP experience desirable.

Other Information

A post-offer, pre-laboratory physical examination will be required.

About This Division

SRI International is a leader in the development of new products for the treatment and diagnosis of disease, primarily in the areas of cancer, infectious disease, neuroscience, and immunology. SRI's Biosciences Division works in several ways, conducting basic research like an academic institution, performing drug discovery and biologic development like a biotechnology company, and carrying out preclinical development and pharmaceutical services like a contract research organization - from "Idea to IND" (tm).

The Biosciences Division works with partners and clients on a broad range of preclinical discovery and development projects, utilizing its expertise in medicinal chemistry, custom organic synthesis, efficacy pharmacology and safety evaluation, pharmacokinetics and metabolism studies, analytical chemistry, formulation design, drug product manufacturing, project management and regulatory affairs. Many studies are conducted under FDA's GLP and GMP regulations. SRI currently has several drugs on the market, several more in clinical trials, half a dozen in preclinical development, and has assisted in the development of more than 130 other products that made it to clinical trials or reached the market.

Abbreviations: IND, investigational new drug application. FDA, Food and Drug Administration. GLP, good laboratory practices. GMP, good manufacturing practices. R&D, research and development.

For additional information, please visit the Biosciences Division website: http://www.sri.com/biosciences

SRI International is seeking a Director of Pharmaceutical Development to lead its growing cGMP clinical dosage program. SRI's pharmaceutical formulation facility is designed for manufacture of Phase I/II investigational drug products including capsules, tablets, semisolids, and parenterals. The successful candidate will develop, plan, and implement dosage preparation and packaging processes and technical operations. Manufacturing processes will be transferred from internal formulation R&D and GLP studies, and sponsors or arise from self-designed pilot studies. This is a unique opportunity to contribute at the interface of formulation development and first-in-man studies.

The successful candidate will ensure the pharmaceutical development team meets client technical, quality, financial, and timeline specifications. This individual will direct manufacturing technicians; coordinate with other internal team members in formulations, quality control, and quality assurance; and keep project management and clients apprised of progress and issues. The Director will prepare/oversee the preparation of SOPs, protocols/reports, and batch records and will manage the calibration and maintenance of the facility and associated equipment. The Director will contribute to strategic planning and business development activities.

Requirements:
Ph.D. in pharmaceutics, chemistry, chemical engineering, PharmD, or a related field with minimum of 10 years relevant, progressively responsible experience in the pharmaceutical industry, including at least 5 years of cGMP regulated activities. Exceptional M.S. candidates with demonstrated capabilities may be considered.

Strong scientific knowledge of solid dosage form processes such as granulation, milling, tableting, and coating. Excellent oral and written communication skills required. Previous contract organization or GLP experience desirable.

Other Information

A post-offer, pre-laboratory physical examination will be required.

About This Division

SRI International is a leader in the development of new products for the treatment and diagnosis of disease, primarily in the areas of cancer, infectious disease, neuroscience, and immunology. SRI's Biosciences Division works in several ways, conducting basic research like an academic institution, performing drug discovery and biologic development like a biotechnology company, and carrying out preclinical development and pharmaceutical services like a contract research organization - from "Idea to IND" (tm).

The Biosciences Division works with partners and clients on a broad range of preclinical discovery and development projects, utilizing its expertise in medicinal chemistry, custom organic synthesis, efficacy pharmacology and safety evaluation, pharmacokinetics and metabolism studies, analytical chemistry, formulation design, drug product manufacturing, project management and regulatory affairs. Many studies are conducted under FDA's GLP and GMP regulations. SRI currently has several drugs on the market, several more in clinical trials, half a dozen in preclinical development, and has assisted in the development of more than 130 other products that made it to clinical trials or reached the market.

Abbreviations: IND, investigational new drug application. FDA, Food and Drug Administration. GLP, good laboratory practices. GMP, good manufacturing practices. R&D, research and development.

For additional information, please visit the Biosciences Division website: http://www.sri.com/biosciences

SRI International - 3 years ago - save job - block
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