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Director, Sr. Director, Drug Substance Manufacturing

Company: Anthera Pharmaceuticals, Inc.
Location: Hayward
Posted on: February 13, 2018

Job Description:

Anthera Pharmaceuticals is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. The company has two product candidates in development. Anthera is searching for a Director/Senior Director, Drug Substance Manufacturing. This role will report to the Senior Vice President of Manufacturing. Job Description Project and Process Management: Develop robust production processes, implement quality principles, achieve product cost targets and manage diverse teams. Run and document appropriate meetings, manage procurement and payment of invoices, and insure timely communication between the contract sites and Anthera management. Work in close collaboration with Anthera's cross-functional teams as well as third party suppliers to develop processes, execute production plans and measure performance against plans. Foster a high-performance environment. Build and maintain a team to meet quality and regulatory goals, as well as commercial goals relating to Cost of Goods Sold, manufacturing yield and overall performance. Manage a diverse organization that may include both internal and external resources and be distributed over a wide geographic area. Budgetary responsibility is considerable, and emphasis is placed on achieving specific budget targets. Responsible for operating all activities in a manner that complies with appropriate safety, regulatory and legal requirements. Technical Oversight: Represent Anthera in a technical capacity to contract manufacturers and other partners, vendors, and subcontractors involved in the manufacturing of Anthera products. Provide appropriate summaries of these interactions to Anthera management. Conduct unbiased, timely, and economical comparisons of possible partners during competitive bidding processes and requests for proposals. Responsible for the production of Anthera's drug substance. Assure the supply and production of a drug substance meets Anthera's quality requirements, production schedules and cost targets. This will involve working with third party suppliers and vendors. Assure quality requirements are met throughout the manufacturing supply chain and production and cost goals are met. Identify and drive process improvements throughout the supply chain. May include process development activities. Provide oversight and guidance to contract manufacturers regarding process development, manufacture, and testing of Anthera products. Perform reviews on a range of technical documents (e.g., technology transfer packages, validation plans and protocols, technical specifications, and master batch records) for manufacturing and analysis of drug substance. Insure that there are good documentation practices at each step of a project. Provide vision concerning drug substance production methods, equipment, process validation requirements (IQ, OQ, PQ), CMC testing and supply chain management tools. Significant liaison activity is required with potential and actual suppliers, as well as business partners. Create an environment where FDA and EMA quality systems are effectively used to deliver products that consistently meet product specifications. Create data packages supporting initial and follow on regulatory agency submissions. Prepare relevant sections of regulatory documents. Business Support: Provide guidance and updates to Anthera management regarding project costs throughout the lifetime of a project. Ensure budget meets corporate objectives. Manage Cost of Goods Sold and drive cost reductions. Provide guidance and updates to Anthera management regarding project timeline throughout the lifetime of a project. Ensure schedule meets corporate objectives. Gain consensus and approval from stakeholders regarding project strategy and execution. Other Responsibilites: Development and execution of clinical and commercial drug substance manufacturing. Assure quality, development and commercialization goals are fully executed according to predefined schedules. Ensure Anthera's policies and procedures are followed and all facilities comply with GMP requirements. Provide leadership for a diverse array of cross functional teams addressing quality, technical, clinical, commercial and organizational issues. Work cooperatively with a wide variety of stakeholders including third party commercial manufacturing suppliers, internal departments and partners. Manage diverse array of projects at multiple vendors to achieve specific strategic and operational goals. Coordinate transition of new products to clinical and commercial operations. Support validation activity and regulatory filings (initial and annual). Ensure information is effectively communicated and managed. Present technical, quality and commercially focused information to diverse audiences in a clear and consistent manner. Provide troubleshooting for a variety of technical, quality, regulatory and commercial issues. Support junior members of the organization by providing mentoring services as requested. Ability to travel nationally and internationally (approximately 20% of the time). Requirements Education: BS/BA degree in related discipline and at least seventeen years of related experience. MS/MA degree in related discipline and fifteen years of related experience. Advanced degree in an engineering, technical or operations discipline a plus. Experience: Typically requires a minimum of fifteen years of related experience and/or combination of experience and education/training. Experience taking a product from Phase 3 to market. Extensive experience in clinical and commercial drug substance manufacturing, with preference given for biologics and enzyme experience. Experience working with outsourced supply chains. Thorough understanding of drug substance manufacturing processes through final packaging. Experience producing clinical and commercial drug substance manufacturing. Experience with increasingly responsible technical management positions in a clinical to commercial drug/device manufacturing environment. In depth experience with FDA, EMA and industry and international regulatory and safety guidelines (21 CFR part 11, GMP, ISO, etc.). Experience with the development of new products, including NDA/IMPD writing. Focus of regulatory related work shall be CMC and validation. Knowledge/Skills/Abilities: Proven track record of success meeting pharmaceutical quality and production schedule goals for multiple products. Experience with biologics and enzyme manufacturing preferred. Process development experience a plus. Demonstrated ability to successfully operate and direct third party vendors supplying products and services. Excellent communication, interpersonal and people management skills. Ability to prioritize competing activities and effectively present prioritized actions for others to execute. Demonstrated ability to multi-task in high pressure, changing conditions in a global development and manufacturing environment. Excellent computer user skills working with MS Office.

Keywords: Anthera Pharmaceuticals, Inc., San Francisco, Director, Sr. Director, Drug Substance Manufacturing, Executive, Hayward, California

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