Director, Chemistry, Manufacturing, Controls (CMC)

Location
Irvine, CA
Posted
Oct 12, 2018
Ref
DCMC
Required Education
Bachelors Degree
Position Type
Full time

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.  Urovant is a nimble company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat. 

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 Director, CMC will lead biologics pharmaceutical development for h-Maxi K and manage clinical trial supplies across multiple clinical studies.

Responsible for directing technical aspects of the biologics process development and manufacturing activities at Urovant’s contract manufacturers organizations (CMOs) and consultants including development, scale-up, validation, launch, and on-going manufacturing support and process improvements, including analytical development and analytical and bio-analytical method transfers and validation.  Responsible for coordinating manufacturing, packaging and distribution of clinical trial materials and set up of drug distribution through IVRS/IWRS.

Support the CMC team in writing IND and NDA’s 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 leading and overseeing all aspects of the manufacture of Urovant’s products  at CROs and/or 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 product including but not limited to:  development, scale-up and validation protocols/reports batch records, deviations, process excursions, analytical methods, protocols and reports.  Contributes in setting up specifications for starting materials, intermediates and drug substance and product.  In conjunction with the CMO and other groups adjudicates deviations and leads or conducts a root cause analysis and implement proposed corrective actions at CRO/CMO.

Education and Experience

  • Bachelor’s or Master’s degree in biology, microbiology, pharmaceutical sciences or related field.
  • 10+ years experience in biologics and/or small molecule pharmaceutical development, pilot plant, commercial manufacturing operations for pharmaceutical APIs (drug substances).
  • Demonstrated scientific knowledge relevant to development and manufacture of drug products, biologics and management of clinical trial supplies
  • 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.

Learn more at http://www.urovant.com