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Executive Director, Product Development & Manufacturing Technical Operations

Company: ChemoCentryx Inc
Location: San Carlos
Posted on: May 16, 2022

Job Description:

Job Description ChemoCentryx is searching for an Executive Director, Product Development and Manufacturing Technical Operations. The Executive Director is responsible for providing strategic direction, technical leadership and operational execution for ensuring successful CMC development activities and clinical manufacturing for all small molecule programs at ChemoCentryx. They are responsible for all phases of drug product development and will support the successful transfer into commercial manufacturing. This Executive Director partners with technical functions, Vifor and global CMO's partners to provide leadership, strategic direction, risk management, and oversight for successful planning and execution across all supporting functions. They will report to the Senior Vice President of Technical Operations and will work out of our corporate facility in San Carlos, CA. The Executive Director will have a strong background in drug substance development, validation and commercial scale manufacturing as well as broad experience in solid oral dosage form development and manufacturing. They will ensure that all development and manufacturing activities are conducted in a manner consistent with multi-territorial (e.g., US, EU, JP) regulatory requirements while integrating quality by design and quality risk management principles into the development and manufacturing processes. A critical aspect of the role is in the identification, selection, qualification and management of Contract Manufacturing Organizations (CMOs). These assessments will necessarily require close collaboration with ChemoCentryx's QA functions (e.g., via quality questionnaire response assessments, qualification audits and quality agreement negotiations). The candidate must also collaborate with internal Analytical subject matter experts to enable the development, qualification and validation of stage-appropriate analytical methods. Essential duties and responsibilities include: Provide strategic direction and technical leadership for CMC development and clinical manufacturing for pipeline programs at ChemoCentryx Oversee and provide technical leadership, strategic direction, risk assessment and oversight for translation of the corporate strategy into supportive strategies for manufacturing, process development, technology transfer and validation for both small molecule drug substance and drug products. Act as a subject matter expert in development activities and risk management. Support Tech Transfer and Life Cycle Management (LCM) projects. Ensure clinical candidates are developed to meet agreed upon Target Product Profiles. Provide oversight of Development Agreements. Manage and oversee CMC development activities at external CROs/CMOs. Working with integrated cross-functional program teams develop budgets and project updates to achieve pre-clinical and clinical development goals and timelines. Ensures spending is in alignment with agreed targets. Provide strategic leadership, technical expertise, and knowledge in drug product formulations supporting commercial and development stage drug products. Rapidly establish and execute programs to develop identified product opportunities. Build relationships and partner with counterparts across the DSP & Sumitovant network to support the advancement of ChemoCentryx programs and initiatives. Directly supervise the drug substance and drug product development function. Responsible for project budget, employee development, project coordination and long range planning. Provide strategic advice and oversight in support of pre-formulation, formulation development, assay development, manufacturing process development, and troubleshooting. Responsible for understanding and applying data generated to modify/optimize formulations and product presentation. Collaborate with the Regulatory, Quality, Clinical, and Analytical Development functions to assure well-defined regulatory submission planning supporting clinical development programs through marketing applications. Author and review or approve CMC development reports, batch records, and other technical documents to support the advancement of CMC development activities. Author and review of CMC sections for regulatory filings. Provide support and contribute to development, manufacturing, and cross-functional goals. Contribute to the development and prosecution of the company's patent portfolio. Travel requirements (at least 30%) Requirements An advanced degree, PhD or MS with 10 years of experience, in Pharmaceutical Chemistry, Organic Chemistry, Process Chemistry, Chemical Engineering at either a Sponsor company or an API CMO is a must for the Sr. Director role. A successful history of accomplishment in the CGMP manufacturing of small molecule New Chemical Entities (NCE's) Solid understanding of all facets and phases of CMC drug development Expertise in synthetic organic chemistry and process development / optimization / validation is highly desired Expertise in API development and CGMP regulations required for the manufacturing of finished product for human clinical studies is highly desired Demonstrated ability to negotiate and manage CRO and CMO contracts and activities Demonstrated technical and project management capabilities for multiple / simultaneous projects with timely and accurate outputs Knowledge of manufacturing processes and methods for cost-control, quality improvements, yield improvements and manufacturing efficiency Adept at creating and communicating a clear vision among direct reports and vendor relationships, effectively developing strategy, aligning resources, and overseeing implementation to achieve program goals Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills Substantial experience managing US and International CRO/CMOs for the manufacture of GMP APIs ChemoCentryx is a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives. At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry. All our employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts. ChemoCentryx employees enjoy a comprehensive benefits package including medical, dental and vision coverage as well as life insurance, and short and long-term disability insurance. Effective September 1, 2021, ChemoCentryx requires all employees to be vaccinated against COVID-19. In accordance with ChemoCentryx's duty to provide and maintain a workplace that is free of known hazards, we adopted this requirement to safeguard the health and safety of our team members, candidates, contractors, and vendors. Any and all job offers will be contingent upon proof of vaccination or an approved exemption from the requirement due to medical or religious reasons. As an equal opportunity employer, ChemoCentryx, Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance. ChemoCentryx, Inc. is enrolled in E-Verify-- and participates in E-Verify-- in addition to our Form I-9 process. . To all recruitment agencies: ChemoCentryx, Inc. does not accept unsolicited agency resumes and will not be responsible for the payment of placement fees related to unsolicited resumes submitted to open positions, job aliases, or to our employees.

Keywords: ChemoCentryx Inc, San Francisco , Executive Director, Product Development & Manufacturing Technical Operations, IT / Software / Systems , San Carlos, California

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