Director/Senior Director, CMC

Summary of Position:

This position is responsible for leading the activities involved in all aspects of biological drug substance development and manufacturing from preclinical to clinical trial material production and ultimately to global product approval and commercialization. The candidate will provide technical expertise to manage multiple contract manufacturing organizations and third-party organizations as well as to internal stakeholders. The successful candidate needs to have expertise in global clinical supply management, including packaging and labeling and procurement of combination therapies and will be responsible for monitoring the CMC budget closely in collaboration with the finance team.

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Job Title:  Director/Senior Director, CMC

Reports to:  Chief Executive Officer

Employment Type:  Full-Time

Location:  United States

FLSA Status:  Exempt

Date:  TBD

Key Essential Functions:

  • Establish, manage, and lead the CMC development plan for drug substances and drug products from pre-clinical through commercial development
  • Coordinates timelines and deliverables through Program Management and other functions, as appropriate; Participate in product development project teams as CMC functional area representative
  • Direct/oversee contract manufacturing, analytical testing, packaging and labeling operations for the company’s drug substances and drug products. Act as primary liaison with contractor(s) on assigned projects. Guide external operations through tech transfer, process and method development, optimization, qualification, and validation of the activities related to all manufacturing operations
  • Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required
  • Develop production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet corporate objectives
  • Provides comprehensive project analysis to senior management as required in the form of reports or presentations as needed
  • Provides and writes relevant documentation for regulatory submissions for global registration of product to ensure successful and timely approval
  • Works with Technical Operations/Quality and Regulatory Affairs to assure compliance to GLP, GMP and GCP requirements; develop SOPs and guidelines related to the production, planning, disposition and management, materials, etc
  • Maintain knowledge of current best practices of biological manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate
  • Coordinates with Technical Operations/Quality the review and audit vendors
  • Select third-party manufacturers working with Quality and Regulatory, negotiate effective supply/technical agreements. Identify contract analytical laboratory sites required to guide and support third party manufacturing relationships. Other duties and responsibilities as assigned
  • Position requires some travel

Required Skills & Abilities:

  • MS or PhD in biological sciences or engineering or BS degree in scientific field plus at least 10 years of experience
  • Experience in leading or being part of a team through the successful approval of a new drug in the US and/or Europe and/or Japan
  • Experience in leading meetings, teams, contract manufacturing organizations
  • Demonstrated management experience including employee development and leadership
  • In-depth experience with issues related to drug substance manufacturing is required
  • Involvement in regulatory interactions / filings involving biologics as well as combination products (drug/device)
  • Knowledge of current requirements for GLP, cGMP, and GCP is also required
  • Direct experience with regulatory submissions
  • Forward-thinking and creative with high ethical standards
  • Team player with leadership skills with ability to influence others to achieve successful regulatory filings and meetings.
  • Well organized and self-directed
  • Strong interpersonal skills with an ability to communicate to people at all levels of an organization

Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.

Company Overview: Aravive, Inc. is focused on treatments for cancer. The company is based in Houston, Texas, and has a satellite office in the Research Triangle Park area in NC. For more information, please visit our website at http://www.aravive.com.

Please send resumes and cover letters to info@aravive.com