Associate Director, Chemical, Manufacturing and Controls (CMC)

Summary of Position:

The Associate Director, CMC is an in-house position located in our Morrisville, NC office. The successful candidate will be responsible for managing development activities from pre-IND stage through scale‑up, BLA filing, product approval, and post-approval filings.  Responsibilities also include high level integration of production and logistical support to Clinical Operations, such as managing labelling and packaging operations and shipments (e.g., domestic and import/export) of clinical trial material (CTM).  This position includes responsibility for providing technical expertise and guidance to manage multiple contract manufacturing organizations and third-party organizations, as well as to internal stakeholders.  This position is responsible for monitoring the CMC budget of the programs and providing supporting information to senior management and the Aravive Board of Directors as needed.

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Job Title:  Associate Director, CMC

Reports to:  Executive Director, CMC

Employment Type:  Full-Time

Location:  Morrisville, NC

FLSA Status:  Exempt

Date:  Spring, 2021

Key Essential Functions:

  • Direct CMC development plans with key deliverables at stage-appropriate milestones in the development program to meet nonclinical, clinical, and regulatory requirements for phase-appropriate clinical studies or scale up and validation for BLA filing;
  • Manage and direct 3rd-party vendors, suppliers, and contract manufacturers for timely delivery of drug substance production, drug product manufacturing, packaging and labelling operations, logistical support (import/export and domestic shipments);
  • Provide project management timelines and updates to teams to accurately integrate CMC deliverables to meet clinical and regulatory milestones;
  • Communicate (in team meetings, emails, or memos) to other departments underlying rationale for CMC deliverables and timing, as well as costs and any impacts on their programs;
  • Assist in preparing budget projections or forecasts based on quotes from vendors and suppliers;
  • Review and approve master batch records from all manufacturing activities; analytical release testing, stability protocols and data, and manufacturing deviations or investigations, as required;
  • Coordinate with Quality Assurance on any manufacturing deviations and or investigations;
  • Coordinate import/export of CTM from China-based CMO and shipments to other clinical depots or sites worldwide;
  • 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;
  • Provide comprehensive project analysis to senior management as required in the form of reports or presentations as needed;
  • Provide and write relevant documentation for regulatory submissions for global registration of product to ensure successful and timely approval;
  • Work with Clinical Operations, QA, 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;
  • Coordinate with QA for review and audit of critical suppliers and other vendors;
  • Participate in the selection process and/or evaluation of 3rd-party suppliers in conjunction with QA and Regulatory, as well as assist in drafting supply/technical agreements;
  • Assist with managing contract analytical laboratories that provide characterization testing, method development, or clinical sample analysis;
  • Interfaces with Aravive corporate partners to coordinate CMC and Technical Operations to support their activities as required;
  • Participate in due diligence evaluations of potential programs; and
  • Travel as required to support the responsibilities noted above.

Qualifications:

  • MS or PhD in biological sciences or engineering and at least 10 years of pharmaceutical development with a minimum of 5 years in biologics development or a BS degree in a scientific field with at least 20 years of experience in pharma/biologics development;
  • Biologics development experience that includes direct interaction or development team experience spanning the entire spectrum of activities from cell culture process development through scale up and process validation;
  • Experience with regulatory submissions and FDA meetings, as well as preparation of documents;
  • Knowledgeable of regulatory requirements for biologics approval in the US and EU such as having worked on BLA filings in either region;
  • Expert knowledge of GLP and cGMP compliance (QA audit experience a plus);
  • Extensive project management experience with ability to multi‑task;
  • Demonstrated experience in drafting written technical summaries, reports, or other memos of CMC activities to team leaders in Aravive and vendors or CMOs; and
  • Strong interpersonal skills with an ability to communicate to people at all levels of an organization.

Knowledge, Skills and Abilities:  Expert knowledge of biologics development  Expert knowledge of cGMP and FDA regulations and guidelines for CMC-related areas  Knowledge of global CMC-related regulatory requirements and guidelines an advantage  Excellent leadership, managerial and communications skills in a cross-functional environment  Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions  Prepare and manage preparation of CMC regulatory filings

Benefits:

  • Medical, Dental, Vision, 401(k)

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 developing treatments designed to halt progression of life-threatening diseases, including cancer. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.

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