Associate Director Process Chemistry
Improving quality-of-life through innovations in urology.
Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.
Every employee at Urovant plays an integral role to our success. We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve. Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.
Urovant’s lead product candidate, vibegron, is a β3-adrenergic agonist being developed for an oral, once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
Urovant’s second investigational product candidate, hMaxi-K, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Associate Director Process Chemistry will lead development of small molecule active pharmaceutical ingredients (API) from a development stage to commercialization and support all aspects of supply chain requirements for API.
The position could be based at Urovant’s site in Durham, NC or Irvine, CA and reports to the Vice President, CMC.
Responsible for directing and overseeing all aspects of the manufacture of small molecules API’s at Urovant’s contract manufacturers organizations (CMOs) including small molecule process development, scale-up, technology transfer, validation, launch, and on-going manufacturing support and process improvements. Responsible for API supply chain development and coordinating manufacturing to ensure adequate supplies to support clinical and/or commercial demand.
Support the CMC team in writing IND and NDA’s drug substance Quality sections, and also provide support of business development activities and due diligences.
- The employee must conduct their work activities in compliance with all Urovant Sciences, Inc. internal requirements, per ICH GMP/ Good manufacturing and ISO requirements and with all applicable regulatory requirements. Urovant Sciences, Inc. internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
- Responsible for establishing and/or managing supply chain for drug substance and leading and overseeing all aspects of process development and manufacture of Urovant’s API’s at CMOs around the world and ensures adherence to project timelines to support clinical and/or commercial supply in line with business objectives.
- Reviews and provides oversight of all documentation related to the production of the API including but not limited to: development, scale-up, technology transfer and validation protocols/reports batch records, deviations, process excursions, protocols and reports. Contributes in setting up specifications for starting materials, intermediates and drug substance. In conjunction with the CMO and other groups adjudicates deviations and leads or conducts a root cause analysis and implement proposed corrective actions at CMOs.
- Collaborates closely with Regulatory Affairs to support CMC activities including writing, reviewing and managing all drug substance sections for any regulatory submission, and ensuring that documents are prepared in accordance with regulatory guidelines, internal standards and SOPs.
Education and Experience
- Master’s or PhD degree in organic or process chemistry, chemical engineering or related field.
- 5 to 10 years experience in the pharmaceutical industry working in development/pilot plant/commercial manufacturing operations for pharmaceutical APIs (drug substances).
- Demonstrated scientific knowledge relevant to development and manufacture of drug substance.
- Must have demonstrated experience in managing and influencing diverse project activities with third party manufacturing facilities at different geographical locations.
- Strong project management experience with cross-functional team leadership and participation skills.
- Requires strong understanding of technology transfer; cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions.
Essential Skills and Abilities
- Self-starter who can work independently and can prioritize tasks.
- Strong communication skills, (both written and oral) including presentations to senior management and external audiences and experts.
- Strong understanding and working knowledge of cGMPs for biologics pharmaceutical development and commercial operations.
- Leadership capabilities for cross functional teams.
- Ability to work across locations and time zones; must be able to travel.