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Job Details

Vice President CMC Development

Location
East Irvine, CA, United States

Posted on
Feb 28, 2022

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Improving quality-of-life through innovations in urology.

 

**MEMBERS ONLY**SIGN UP NOW***.. 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.

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nnnnPosition Descriptionnnn

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Reporting to the SVP, CMC Development and Technical Operations, the Vice President, CMC Development, will be responsible for providing strategic direction, technical leadership and operational execution for ensuring successful CMC development activities and clinical manufacturing for all small molecule and biologics programs at Urovant.  Responsible for all phases of drug product development and will support the successful transfer into commercial manufacturing.  This position partners with Urovant CMC / Technical functions and global CMO's partners to provide technical leadership, strategic direction, risk management, and oversight for successful planning and execution across all supporting functions.  We are looking for an experienced leader who will help us build an organization fit for growth to successfully deliver innovative therapies to the patients we serve. This person will also build relationships and partner with counterparts at our parent companies, Sumitomo Dainippon Pharma Company, LTD. and Sumitovant Biopharma LTD, to establish a strong collaborative culture that leverages operational synergies and expertise effectively from each other when appropriate. They will also provide guidance to product and business development teams during review of potential new drug product candidates and partnerships.

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nnnnKey Duties and Responsibilitiesnnn

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  • Provide strategic direction and technical leadership for CMC development and clinical manufacturing for small molecule and biologics at Urovant's global CMO / CRO network.
  • Oversee and provide technical leadership, strategic direction, risk assessment and oversight for translation of the corporate strategy into supportive strategies for manufacturing, quality control, process development, analytical development, technology transfer and validation.
  • Act as a subject matter expert in development activities and risk management.
  • Support Tech Transfer and Life Cycle Management (LCM) projects.
  • Ensure clinical candidates are developed to meet agreed upon Target Product Profiles.
  • Provide oversight of Development Agreements.
  • Manage and oversee CMC development activities at external CROs/CMOs.
  • Ensures Phase 1 Lifecycle Validation studies and knowledge are being completed as a part of CMC development activities.
  • Prepares and monitors cost budgets for CMC development projects. Ensures spending is in alignment with agreed targets.
  • Provide strategic leadership, technical expertise, and knowledge in drug product formulations supporting commercial and development stage drug products. Rapidly establish and execute programs to develop identified product opportunities.
  • Build relationships and partner with counterparts across the DSP & Sumitovant network to support the advancement of Urovant or Sumitovant / DSP programs and initiatives.
  • Directly supervise the CMC Development function. Responsible for project budget, employee development, project coordination and long range planning.
  • Provide strategic advice and oversight in support of pre-formulation, formulation development, assay development, manufacturing process development, and troubleshooting. Responsible for understanding and applying data generated to modify/optimize formulations and product presentation.
  • Contribute to developing global regulatory filings strategies and serve as SME for areas of responsibility in meeting with regulatory authorities.
  • Collaborate with the Regulatory, Quality, Clinical, and Translational Sciences functions to assure well-defined regulatory submission planning supporting clinical development programs through marketing applications.
  • Author and review in collaboration with CMC Regulatory appropriate CMC sections of global regulatory submissions to support regulatory filings.
  • Review protocols, investigator brochures, to support clinical activities.
  • Author and review or approve CMC development reports, batch records, and other technical documents to support the advancement of CMC development activities.
  • Provide scientific review/recommendations regarding potential business development opportunities as requested.
  • Provide support and contribute to development, manufacturing, and cross-functional goals.
  • Contribute to the development and prosecution of the company's patent portfolio.
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nnnnEducation and Experiencennn

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  • PhD or master's degree in chemical or biological sciences.
  • 15 years of biopharmaceutical industry experience with no less than 12 years of that experience focusing on small molecule and biologics manufacturing CMC development.
  • Minimum of 12 years of experience in a leadership position in CMC/Product Development.
  • Demonstrated experience in successfully bringing development compounds through clinical phases to post commercial launch.
  • Significant experience working with external CROs/CMOs.
  • Extensive development experience with Upstream/Downstream Process Development, Formulation/Drug Product Process Development, and Analytical Operations.
  • Extensive development experience with API chemical synthesis, solid dosage and parenteral drug products.
  • Demonstrated scientific knowledge relevant to development and manufacture of drug products and management of clinical trial supplies.
  • 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.
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nnnnEssential Skills and Abilitiesnnn

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  • Strong leadership skills, including demonstrated ability to lead a cross-functional technical team made up of internal and external resources, and to influence at all levels of an organization.
  • Successful track record of developing collaborative, productive relationships across all functions and levels both internally and externally and the ability to manage and gain support of multiple stakeholders.
  • Navigate and work collaboratively in a complex and global environment.
  • Ability to manage 3rd party relationships, providing technical oversight of the CMC Development and clinical manufacturing activities.
  • 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 the CMC development stages, required regulatory CMC studies, manufacturing processes of small molecule, biologics and gene therapy products.
  • Requires strong understanding of development, scale-up, validation and technology transfer; cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions.
  • 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 to the extent permissible under federal and state laws and subject to legally-recognized accommodations.

 

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