Director, Analytical Development

Piper Companies is seeking a Director, Analytical Development to join an innovative biotechnology organization focused on advancing therapies for patients with significant unmet medical needs for a fully remote, permanent position. The Director, Analytical Development will serve as the analytical and CMC lead for a high-priority development program, overseeing analytical strategy, external partners, and cross-functional collaboration while helping accelerate complex pharmaceutical programs through key development milestones.

Responsibilities of the Director, Analytical Development include:

· Lead analytical development activities for drug substance and drug product programs, including method development, validation, stability, release testing, and technology transfer initiatives.

· Act as the primary analytical and CMC representative on cross-functional project teams, partnering closely with formulation, regulatory, quality, clinical, and program leadership stakeholders.

· Manage CROs, contract laboratories, and manufacturing partners to ensure timely execution of analytical development objectives and deliverables.

· Provide technical leadership during investigations involving deviations, OOS/OOT results, and analytical challenges while driving practical, science-based solutions.

· Guide analytical strategy, data review, regulatory submission support, and lifecycle planning in a fast-paced environment with evolving priorities and timelines.

Qualifications for the Director, Analytical Development include:

· MS degree in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related scientific discipline.

· 7+ years of pharmaceutical, biotechnology, or contract research experience with expertise in analytical development, CMC activities, and drug development programs.

· Strong knowledge of analytical techniques including HPLC, dissolution testing, impurity profiling, physicochemical characterization, and method development.

· Experience managing CROs, external laboratories, and technical vendors while influencing cross-functional teams and stakeholders.

· Working knowledge of cGMP requirements, USP/EP/JP standards, and FDA, EMA, and ICH regulatory guidelines with strong communication and leadership skills.

Compensation for the Director, Analytical Development:

Salary Range: $140,000-$170,000/year (USD)

Comprehensive Benefits: Medical, Dental, Vision, 401(k), bonus opportunity, equity participation, paid time off, and additional company-sponsored benefits.

This job opens for applications on 9/9/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: analytical development, CMC, chemistry manufacturing and controls, pharmaceutical development, biotechnology, HPLC, dissolution testing, impurity analysis, analytical methods, method validation, method transfer, stability studies, drug substance, drug product, formulation development, regulatory submissions, FDA, EMA, ICH, USP, cGMP, quality assurance, quality control, CRO management, vendor management, technology transfer, analytical strategy, lifecycle management, pharmaceutical sciences, investigational products, clinical development, project leadership, cross-functional collaboration, pharmaceutical manufacturing, data analysis, stability programs, deviation investigations, OOS, OOT, validation protocols, technical operations, leadership, stakeholder management.

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