Executive Director, Bioanalytical Development (Rochester)

Executive Director, Bioanalytical Development

About the Company

Innovative biotech company developing life-transforming therapeutics for genetically driven diseases.

Industry

Biotechnology

Type

Public Company

Founded

2018

Employees

51-200

Categories

• Biotechnology
• Academic Research
• Genomics
• Health Care
• Pharmaceuticals
• Clinical Care
• Laboratory Services

About the Role

The Company is seeking an Executive Director, Head of Bioanalytical Development to lead the bioanalytical capabilities for the advancement of therapeutics targeting genetically driven neuromuscular diseases. The successful candidate will be responsible for the development, validation, and implementation of robust PK and immunogenicity assays to support the transition from bench to clinic, covering the entire development process from discovery through IND, late-stage clinical development, and licensure. This role involves building and leading a high-performing team, overseeing assay development for PK and ADA, and ensuring compliance with global regulatory standards. The Executive Director will also be the primary scientific interface with external partners, driving strategic initiatives, and championing the adoption of cutting-edge technologies in bioanalysis.

Applicants for this role at the company should have a Ph.D. or equivalent in biochemistry, pharmacology, or a related field, with a minimum of 10-12 years' experience in bioanalytical sciences within the biopharmaceutical industry. The ideal candidate will have a proven track record of leadership, deep expertise in bioanalytical assay development for both biologics and small molecules, and a strong understanding of regulatory requirements. Experience in a fast-paced biotech environment, a history of innovation in bioanalysis, and excellent communication, organizational, and project management skills are essential. The role requires the ability to influence cross-functional teams, drive strategic initiatives, and ensure the highest quality and regulatory compliance in all bioanalytical operations.

Hiring Manager Title

head of Translational Biomarkers

Travel Percent

Less than 10%

Functions