Director, Pharmaceutical Manufacturing

Director, Pharmaceutical Manufacturing

Hybrid role in Brisbane, CA

Contract through end of year then will renew

Position Summary:

·        Experienced operations leader to support CMC development and manufacturing of clients drug product formulations for small molecule products that are integrated into multiple product platforms

·        The role requires leadership skills including CMC partnership, manufacturing, and CMO relationship management of various projects

·        This position interacts with several other CMC quality & regulatory functions in client and at CMOs, in addition to supply chain management, translational research, technical development, and clinical teams within the company

Responsibilities:

·        Manage/lead external drug product manufacturing of small molecules in a cGMP environment.

·        Manage/lead production planning, execution, and tracking. Ensure fulfillment of agreed manufacturing services for clinical and commercial supply

·        Manage CMO relationships and foster collaborative partnerships. Lead and/or contribute to CMO selection and onboarding

·        Support and/or lead CMC projects of client´s small molecule portfolio. Author and/or provide inputs to CMC sections in support of global regulatory filings

·        Be an integral part of cross-functional and cross-discipline CMC teams for products that include synthetic components

·        Develop and maintain CMC manufacturing activities, Product Design History File and Quality Risk Management Plan

·        Manage process development and optimization technology transfer as well as production related change controls, deviations, and complaints

·        Drive RFPs, SOWs, MSAs, and other governance documents

·        Promote and implement knowledge management processes for appropriate sharing and storage of documentation

·        Provide representation on global projects and in functional and cross-functional teams

Requirements:

·       Ph.D. or equivalent work experience in Pharmaceutical or Engineering Sciences

·       10 years or more of relevant experience in small and/or large biopharmaceutical companies and working in global organizations

·       Demonstrated experience with participation in and/or leading CMC teams and executing CMC activities

·       Experienced in development and clinical manufacturing of small molecule formulations and manufacturing of drug products. Experience in formulation of multiple dosage forms is preferred

·       Experienced in QbD, DoE, process optimization and qualification/validation, phase-appropriate manufacturing controls, up-to-date with new mfg technologies including PAT, and familiarity with current regulatory landscape for small molecule DPs

·       Working knowledge of quality and regulatory requirements of small molecule products, including ICH guidelines; knowledge of antisense oligonucleotide products would be a plus

·       Experience with analytical development and quality control is an advantage

·       Proven accomplishments and experience in cGMP manufacturing, external manufacturing, and working in a highly matrixed organization

·       Track record with ability to build and sustain effective CMO partnerships

·       Ability and experience to contribute to regulatory filing processes including INDs, IMPDs, NDAs, MAAs, and other regulatory related documents

·       Ability to work with business systems and processes including legal, finance, quality, as well as manufacturing and supply chain operations

·       Experience in continuous improvement, operational and business process excellence projects.

·       Excellent problem-solving skills as well as verbal and written communication skills in English are required. Skills in additional languages such as German are strongly welcomed

·       Travel approximately 25%