Director/Senior Director, Commercial Manufacturing

Location
Irvine, CA
Posted
Jul 02, 2022
Ref
2022-1553
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Improving quality-of-life through innovations in urology.

 

Urovant Sciences, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions and 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, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist approved by the U.S. FDA in December 2020 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.  GEMTESA® is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH).

 

Urovant's second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.

Position Description

Urovant Sciences is currently seeking a Senior Director, Commercial Manufacturing.  Working closely with the VP, Commercial Manufacturing, this role will be responsible for execution of operational plans to ensure reliable and compliant Commercial Manufacturing of key raw materials (RMs), active pharmaceutical ingredients (APIs), drug product (DP) and packaging across Urovant's global CMO manufacturing network.  This position oversees global CMO's and provides operational and technical leadership, strategic direction, risk assessment, and oversight for successful planning and execution across all supporting functions.  The ideal candidate will be a seasoned pharma/biotech Director with a strong record of accomplishment in Late Stage Clinical and Commercial cGMP Manufacturing of small molecule and biologics products using global CMO's.

Key Duties and Responsibilities

  • To ensure compliant and reliable commercial manufacturing of key RMs, API, DP and packaging.
  • Establish Manufacturing Excellence at CMOs for small molecule. Biologics products a plus.
  • Understand and enforces Supply and Quality Agreements.
  • Provide guidance and direction for manufacturing production goals, budgets, and other operational activities to ensure Right First Time (RFT) manufacture and timely delivery of drug substance and drug product materials to meet program and company goals.
  • Ensures manufacturing instructions are technically and operationally well written to ensure compliant and successful execution of all production steps.
  • Manage drug substance and drug product CMOs for manufacturing operations, technology transfers, investigations, and batch documentation reviews and responsible for continuous improvement and operational excellence at CMOs.
  • Collaborate with the global cross functional Team to support company objectives.
  • In collaboration with CMC Regulatory, author regulatory and technical documents for regulatory submissions in support of manufacturing and serve as subject matter expert in regulatory interactions.
  • Maintain a high level of safety, compliance, and efficiency to drive the organization to world-class manufacturing standards.
  • Monitors and identifies key process and business performance indicators for each of the sites and implement improvements as appropriate.
  • In partnership with Quality and Manufacturing Sciences to conduct risk assessments on commercial manufacturing processes and develop risk mitigation plans.
  • Working with project-based CMC teams, directly contribute to and represent Operations in areas of process and product development strategy.
  • Author, review and/or approve deviation and investigation reports, change controls, and corrective/preventative actions (CAPA) when appropriate.

Education and Experience

  • BS in chemical sciences / engineering or related field.
  • 10+ years of technical experience with small molecule API drug substance / drug product development and manufacturing environment. Biologics / gene therapy experience a plus.
  • 7+ years' operational experience directly supporting and/or managing manufacturing or technical operations at external API / DCMO's.
  • Demonstrated scientific knowledge relevant to development and manufacture of drug substance, drug product and management of commercial / clinical trial supplies.
  • Demonstrated experience in successfully bringing development compounds through clinical phases to post commercial launch.
  • Extensive understanding in the areas of manufacturing, validation, tech transfer, quality, supply planning and Tech Ops business systems.
  • Working understanding of cGMP, GLP, GCP and GvP compliance requirements associated with U.S., EU, ICH and other pertinent regulatory agencies.
  • Knowledgeable in LEAN principles and Manufacturing Excellence.

Essential Skills and Abilities

  • Strong leadership and change management skills, including demonstrated ability to lead a global cross-functional team, and to influence at all levels of an organization.
  • Navigate and work collaboratively in a complex and global environment.
  • Ability to manage 3rd party relationships, providing manufacturing oversight of raw materials, API, drug product and packaging.  Ability to assess future needs against current realities, formulate winning strategies, articulate and translate these into effective operational directives / plans.
  • High degree of emotional intelligence and strong listening skills.
  • Must effectively build the team and systems, coach existing staff and contribute “hands on” to the daily required work.
  • Must be systems orientated with demonstrated success on implementing scalable processes.
  • In depth knowledge of commercial manufacturing of small molecule, biologics and gene therapy.
  • An entrepreneurial approach to develop new, innovative ideas that will drive growth within the Manufacturing organization.
  • The ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion.
  • Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
  • Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues to the executive leadership.
  • Develop effective and efficient working relationships with both internal and external partners.
  • Available to travel if/when needed.

 

To ensure the health and safety of our workforce while doing our part to protect those around us, Urovant Sciences is requiring proof of full COVID vaccination for US and Global employees as a condition of employment, subject to legally-recognized accommodations.

 

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