Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. 

The Opportunity: Sr. Scientist/Associate Director, Analytical Development:

We are seeking a Sr. Scientist/Associate Director of Analytical Development to join the team at Ventyx Biosciences. This individual will lead all analytical chemistry development activities across our 3 clinical-stage programs, with a fourth to enter the clinic in early 2023. The candidate’s expertise will guide internal and external CMC efforts in all technical and strategic aspects of these programs. The Associate Director of Analytical Development will be responsible for leading all analytical chemistry activities in support of our growing pipeline of clinical development programs. This position will report to the Senior Director & Head, Process Chemistry.

What You Will Contribute:

• Advance technical leadership for all CMC analytical activities, including specification setting, test method development and validation, and outsourced QC testing for drug substance/drug product.
• Drive direction utilizing intimate knowledge of ICH guidelines pertaining to DS/DP quality and patient safety.
• Lead cross-functional collaborations to establish phase-appropriate specifications and analytical control strategies for starting materials, intermediates, drug substance, excipients, and drug product.
• Lead the characterization of starting material, intermediate, drug substance, and drug product-related process impurities and degradation products.
• Provide analytical oversight for solid-state characterization studies of drug substance/drug product.
• Accountable for design, development, and phase-appropriate validation of critical test methodologies, including chiral and achiral HPLC, GC, IC, in-vitro dissolution, and techniques for quantification of potential mutagenic impurities (PMIs).
• Establish and maintain outsourced ICH stability programs for drug substance and drug product.
• Prepare/review request-for-proposals (RFP) and manage day-to-day analytical development and testing activities at CDMOs and contract test labs to assure that projects remain on-track.
• Partner closely with CMC colleagues and QA to (1) write or review test methods, SOPs, analytical data summaries (CoA), protocols, and technical reports, (2)critically review, trend, and interpret analytical testing results, and (3) support investigation of nonconformances (OOS/OOT results, deviations, etc.). 
• Communicate and present analytical data in CMC meetings and other cross-functional settings.
• Author CMC analytical sections in INDs and other regulatory filings and responses to queries from health authorities.
• Collaborate effectively with internal and external stakeholders to deliver on program objectives.
• Additional duties assigned as needed.

What We Seek:

• 7+ years of experience in clinical-stage analytical development or equivalent combination with advanced degree
• PhD degree in analytical chemistry or related field; or 4+ years of highly related experience in lieu of degree required
• Demonstrated expertise in analytical development of small molecule therapeutics covering both drug substance and drug product
• Thorough understanding of regulatory expectations at various stages (IND/IMPD through NDA/MAA) of the drug development process is essential
• Experience in managing analytical method development and validation activities at 3rd party vendors is necessary
• Strong oral & written scientific communications skills
• Excellent organization skills
• Collaboration, teamwork, and passion for excellence
• Motivated to work in a fast-paced, high accountability environment
• Highly effective at both initiation and closure of critical activities.
• Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team
• Ability to travel 5–10% as necessary

 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 $160,000 - $195,000. 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.
Ventyx is an equal opportunity employer and strives to maintain a work environment in which all individuals are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race, age, ethnicity or national origin, color, religion, sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity, sexual orientation, disability or medical condition (including genetic information or characteristics or those of a family member), military service or veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

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 careers@ventyxbio.com.