Job Description

Senior Director / Vice President, Technical Operations

Position Summary

Antiva Biosciences, Inc. a well-funded venture-backed clinical stage biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions and infections caused by HPV, is seeking a Senior Director / Vice President, Technical Operations leader to join its team. Reporting to the SVP, Pharmaceutical Development and Manufacturing, the Sr. Director / Vice President, Technical Operations will be responsible for providing strategic direction, technical leadership and operational execution for ensuring successful CMC development activities in support of Antiva’s clinical programs. This position will partner with CMC, Quality and Clinical functions as well as global CMO partners to provide technical leadership and direction to Antiva’s drug manufacturing efforts. The successful leader will partner with senior management in developing strategy and driving the technical activities for Antiva’s pharmaceutical development, innovation and technology development activities. This hands-on role will be responsible for collaboratively planning and executing phase appropriate development and manufacturing activities for drug-device combination products, managing contract manufacturers, integrating drug substance, drug product and analytical methods development, and partnering with cross-functional team members in supporting corporate goals.

Specific Responsibilities Include (but not limited to):

  • Provide technical leadership to the CMC team in the development of drug-device combination products. Support project goals and strategy for stage-appropriate development, efficiently manage budgets and resources (both internal and external), and ensure timely delivery of drug substance, drug product, and clinical supplies in alignment with project objectives. Partner with senior management in long-term strategy and policies development, and implementation consistent with current industry practices, preparation for Board meetings and partnering activities.
  • Develop stage-appropriate solutions for complex challenges, including cross-functional activities, and manage near-term and long-term plans. Define process development criteria, perform risk analysis and oversee scale-up incorporating QbD aspects into development. 
  • Build long-term strategic partnerships with contract organizations, collaborate with internal and external team members (consultants and contract vendors) in developing/authoring protocols and reports.  Lead or support manufacturing records, method protocols and reports development, data analysis including trend analysis, deviations, out-of-trend and out-of-specification investigations and efficient closure of the investigations etc.
  • Effectively communicate cross-functionally with Toxicology, Quality Assurance, Regulatory Affairs, Clinical Operations, and Project Management, build consensus and ensure that corporate strategic objectives are accomplished.
  • Prepare CMC reports and Regulatory documents. Assist in maintaining CMC documentation systems, coordinate writing of CMC sections for Regulatory submissions.

Requirements

  • BA or BS degree with a minimum of 20 years of relevant experience in the pharmaceutical industry is required. PhD or an advanced degree in related discipline, is highly preferred.
  • Proven track record of strategic leadership and management with at least 10 years in a leadership/management role.
  • Demonstrated strong project and cross-functional team leadership, as well as people management and mentoring skills.
  • Thorough understanding and working experience in drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
  • Strong problem-solving skills with strategic and sound technically driven decision-making ability.
  • Strong track record as technical lead with experience in manufacturing of cGMP materials to support global drug product supply.
  • Management of CMOs, CMC teams, excellent oral and written communication, organizational and interpersonal skills, building positive relationships across functional teams are required.
  • Understanding of drug-device, drug substance, drug product, analytical methods development, and clinical supplies management is desired.
  • Strong track record of collaborative working relationship with external vendors (i.e. CDMOs) which has led to successful outcomes for the business.
  • Ability to collaboratively work within a team environment, report on projects and drive them to conclusion.
  • Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines, and able to manage/mentor junior level colleagues as needed.
  • Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment.
  • Ability to proactively identify challenges, possess strategic foresight and implement appropriate course of action.
  • Excellent organizational, oral/written communication and time management skills are required.
  • Must be able to innovate, analyze and solve problems with minimal supervision and strong attention to detail.
  • Travel to CMOs as needed to support project need.

How to Apply

To apply, please mail or email your CV and cover letter to:

Antiva BioSciences, Inc.
Attn: Human Resources
555 Twin Dolphin Drive, Suite 620
Redwood City, CA 94065
Email:

Antiva is an equal opportunity employer.

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