Ventyx Biosciences, Inc. is a clinical-stage, public biopharmaceutical company focused on advancing new therapies for millions of people living with inflammatory diseases and autoimmune disorders. We are developing novel and differentiated therapeutics that target both the innate and adaptive immune system. Our clinical-stage programs include an allosteric TYK2 inhibitor for the treatment of a broad range of autoimmune diseases, an S1P1 receptor modulator for the treatment of ulcerative colitis, and both peripheral and CNS inhibitors of the NLRP3 inflammasome, which is a mediator of multiple inflammatory conditions. Join this team of life science professionals to bring this portfolio of programs to fruition.

The Opportunity: Senior Director, Analytical Development

Reporting to the Executive Vice President, Technical Operations and Quality Assurance, the Director/Senior Director, Analytical Development will lead Ventyx's analytical development team and ensure proper testing and release of drug substance and drug product for Ventyx's small molecule programs at contract service providers (CSPs).

What You Will Contribute:

* Design, build, and lead the Ventyx Analytical Development function
* Develop and oversee strategy for phase-appropriate deployment of analytical methods and testing for early and late phase drug development programs at CSPs including analytical method development, qualification, and validation for drug substance and drug product
* Develop and set specifications for raw materials, intermediates, drug substance, excipients, and drug product
* Design and manage stability programs for non-GMP and cGMP drug substance and drug product batches and provide guidance for shelf-life and expiry dating
* Develop strategies for reference standards programs, coordinate sourcing, ensure inventory, plan and execute testing and retesting activities, and manage shipments of reference standards across Ventyx's CSP network
* Author, review and approve analytical reports in a timely manner to support drug substance and drug product development and manufacturing activities and regulatory filings.
* Support regulatory submissions by drafting and reviewing analytical sections of INDs, IMPDs, and NDAs, and ensure compliance with current regulatory requirements
* Work closely with senior management team to initiate new projects and drive implementation to meet objectives
* Collaborate with Discovery, Tech Ops, Quality Assurance and Regulatory team members to support tech-transfer activities
* Contribute significantly to the development of phase-appropriate method qualification and work with QC to develop validation protocols and test method SOPs for routine performance of these assays
* Effectively communicate results of departmental work to other parts of the organization both verbally and in writing
* Participate in and contribute to developing strategy and budget planning
* Perform work in accordance with relevant regulatory agency guidance (e.g., FDA, ICH, EMA, etc.) as well as Company policies and procedures

What We Seek:

* PhD in analytical chemistry or related discipline with more than 10 years of industry experience or BS/MS degree with more than 15 years industry experience. Experience with late stage clinical and commercial products is preferred
* Broad technical expertise in analytical development for small molecule drug products
* Proven experience in developing and implementing analytical methods used to support product development, characterization, and release testing
* Working knowledge of CMC regulatory requirements for pharmaceutical products in various stages of development as well as practical application of principles of QbD
* Extensive experience working with drug substance and drug product CSPs on analytical projects
* Outstanding at problem-solving and applying creative innovative solutions to multi-faceted problems and issues and a passion for working in a fast-paced and evolving organization
* Experience developing and leading a high-performing team of scientists and associates
* Ability to deliver under tight timelines and adapt to changing project needs
* Ability to work on multiple projects at the same time
* Ability to communicate, organize, and write well

What We Provide to You:

* The opportunity to make a difference in people's lives impacted by autoimmune and inflammatory diseases.
* Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.
* Competitive compensation and a comprehensive benefit package, including stock options.

The anticipated annual base salary range for this role is $220,000 to $265,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, company needs, and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees.

Job candidates should be aware that full vaccination against COVID-19 is required as a condition of employment subject to legally required exceptions. Ventyx is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed.

Notice to Recruiters and Agencies:

The Human Resources team manages the recruitment and employment process for Ventyx Biosciences. To protect the interest of all parties involved, Ventyx Biosciences does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing or recruiting agencies or fee-based referral services. The submission of referrals or resumes by anyone other than a candidate directly to Ventyx Biosciences' employees is strictly prohibited. Unsolicited referrals and resumes sent to Ventyx are deemed gratuitous, and do not obligate Ventyx to pay fees should we hire from those resumes. Recruiters are requested NOT to contact or present candidates directly to our hiring managers or employees. Please direct all inquiries to [ Email address blocked ] - Click here to apply to Senior Director, Analytical Development.