Director / Senior Director, Pharmaceutical Development
Antiva Biosciences, Inc. is a privately held San Francisco Bay Area-based biopharmaceutical company focused on the development of antiviral therapies. The company is using a new medicinal chemistry platform to develop antiviral therapies, focusing first on HPV. Antiva has additional molecules that target HIV, the herpes virus, cytomegalovirus and others. Antiva’s lead compound,
Specific Responsibilities Include But Not Limited To:
- Participate in the planning and execution of pharmaceutical development activities as well as manage contract manufacturers, integrate drug product development with drug substance and analytical methods development etc., and work with cross-functional team members supporting corporate goals.
- Support the development of project strategy, goals, budgets and other pharmaceutical development operational activities. Acts as senior technical leader for the CMC Team, integrating internal and external team members’ activities into the pharmaceutical development plan.
- Support senior management in long-term strategy, preparation for Board meetings and Due Diligence activities, and development and implementation of policies consistent with current industry practices.
- Integrate CMC development and clinical supplies manufacturing efforts at contract manufacturers (CMOs), efficiently managing budgets and timelines, and negotiating resources to achieve project goals reliably delivering quality product. Work closely with other CMC Team members, planning and managing stage-appropriate development for drug substance, drug product and analytical development.
- Partner with pharmaceutical development team and head of project management in developing and updating project work-plan (time, resource and cost estimate), setup contracts and agreements, CDAs, MSAs etc. for all Pharmaceutical Development materials and services.
- Define topical dosage formulation and process development criteria, perform risk analysis, oversee scale-up incorporating QbD aspects into development, develop long-term plans for process validation and bridging for commercial products development. Develop stage-appropriate solutions for complex challenges, impacting other functions across the company, managing near-term and long-term plans.
- Collaborate with internal and external (CMOs) 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.
- Prepare CMC reports and Regulatory documents. Assist in maintaining CMC documentation systems and coordinate writing of CMC sections for Regulatory submissions.
- Bachelors’ degree with a minimum of 10-12 years of relevant experience in the pharmaceutical industry doing formulations development is required. PhD or an advanced degree in Pharmaceutics or related discipline, and topical dosage forms development experience are highly preferred.
- Strong track record as technical lead with experience in manufacturing of cGMP materials for 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 substance and analytical methods development, and clinical supplies management is desired.
- Work in fast paced environment with multiple priorities. Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment.
- 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
6000 Shoreline Ct. Ste 203
South San Francisco, CA 94080
Antiva is an equal opportunity employer.