Associate Director, Analytical Development & Quality Control

Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company's in-house precision medicine platform, SNÅP, enables the rapid and precise refinement of structural drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA's initial focus is on applying its accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions. TYRA is based in Carlsbad, CA.

Position Overview:

The Associate Director of Analytical Development & QC will lead the development, optimization, and validation of analytical methods— with a particular emphasis on dissolution method development for oral dosage forms. This role requires a strong technical foundation, the ability to work independently in a remote environment, and experience supporting small‑molecule CMC activities. The ideal candidate brings a deep understanding of analytical sciences, quality systems, and outsourced lab management.

This role will work closely with internal team members as well as with external partners.

Responsibilities include, but are not limited to:

Analytical Development

• Lead development, optimization, qualification, and validation of analytical methods for small‑molecule drug substances and drug products, with expertise in dissolution method development.
• Oversee method lifecycle management, including transfer to CMOs.
• Serve as the analytical SME for formulation development, regulatory filings, and CMC strategy.
• Review and interpret analytical data, stability studies, trending, and investigations.
• Author and review method development reports, validation protocols, analytical sections of regulatory submissions (IND, IMPD, NDA, etc.).

Quality Control & Compliance

• Provide oversight of outsourced QC testing activities to ensure compliance with cGMP, ICH, and regulatory expectations.
• Lead OOS/OOT investigations, change control, and deviation resolution.
• Establish and maintain analytical quality standards, specifications, and acceptance criteria.
• Support stability program design and execution.

Cross-Functional Leadership

• Collaborate with Formulation, Quality, Regulatory, and CMC teams to support program deliverables.
• Manage vendor relationships, including CRO/CMO oversight for analytical and QC activities.
• Provide scientific guidance to project teams and senior leadership.
• Facilitate effective and open communications with all stakeholders
• Support other various CMC-related initiatives as needed.

Position Requirements & Experience:

• Advanced degree (MS or PhD) in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related field; BS degree considered with strong experience.
• Minimum 5 years of hands-on laboratory experience in analytical method development for small‑molecules, and/or
• Demonstrated expertise in dissolution method development (USP, in vitro release testing, sink conditions, discriminating methods, etc.).
• Strong understanding of HPLC/UPLC, GC, spectroscopy, compendial methods, and physical characterization.
• Experience with method validation and transfer in accordance with ICH guidelines.
• Working knowledge of GMP, ICH Q2/Q14, and regulatory expectations for small‑molecule products.
• Proven ability to manage CROs/CMOs and oversee outsourced analytical work.
• Experience supporting early through late-stage development programs.
• Familiarity with Quality Systems for small biotech environments.
• Experience contributing to regulatory submissions (IND/NDA).
• Strong data interpretation, problem‑solving, and technical writing skills.
• Experience with cross-functional team roles and responsibilities in pharmaceutical development, with a track record of influencing and problem solving to find creative solutions to technical issues that arise.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Proven ability to manage competing priorities in a fast-paced, rapid-growth environment.
• Ability to work independently and collaboratively adapt as part of a team.
• Strong interpersonal skills, including verbal and written communication.
• Candidates must be authorized to work in the U.S.
• Travel may be required up to 30%.

Pay Range and Benefits:

Base Salary Range: $193,094 - $207,764 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Employees:

· Competitive base, bonus, new hire and ongoing equity packages

· The starting compensation range(s) for this role is for a full-time employee (FTE) basis

· Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment

· Employer -paid Medical, dental, and vision insurance

· Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage

· 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions

· Employee Stock Purchase Plan

· 14 -18 paid holidays, including office closure between December 25th and January 1st

· Flexible vacation

· Sick time

· Fitness Program

· Get Outdoors Program

· Paid parental leave benefit

· Tuition assistance

Job Type: Full-Time

Work authorization: United States (Required) Work Location: Remote flexibility with periodic in-person collaboration

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.