Director, Bioanalytical Laboratory (Medtech)

TL;DR

Director, Bioanalytical Laboratory (Medtech): Planning and directing the resources of a bioanalytical laboratory performing assay validations and sample analysis with an accent on GLP/GCLP compliance and continuous quality improvement. Focus on overseeing biomarker, immunogenicity, and pharmacokinetic assays while managing staff and operational budgets.

Location: Onsite in Gaithersburg, MD, USA

Salary: $174,100 – $272,100 per year

Company

hirify.global is a provider of specialized bioanalytical technology and services for the life sciences industry.

What you will do

• Direct the operations of the Bioanalytical Laboratory (BAL), ensuring full compliance with local, state, and federal regulations.
• Serve as the subject matter expert for biomarker, immunogenicity (IG), and pharmacokinetic (PK) assays.
• Establish and maintain GLP and GCLP compliant procedures, documentation, and information systems.
• Manage laboratory budgets, including staffing, operating expenses, materials, and capital equipment.
• Lead and evaluate staff performance, coordinate training plans, and identify high performers for succession planning.
• Oversee daily laboratory operations, including testing schedules, quality control, and safety requirements.

Requirements

• Ph.D. in Biology, Chemistry, or related scientific discipline (Master’s degree may be substituted with additional relevant experience).
• Minimum 10 years of experience in immunoassay development (industrial) or bioanalytical sample testing in a GLP/GCLP environment.
• Minimum 6 years of experience leading biomarker development or bioanalytical sample testing projects.
• Minimum 4 years of supervisory experience.
• Training and experience with GLP/GCLP is required.
• Must be based in or able to work onsite in Gaithersburg, MD, USA.

Nice to have

• Expertise in pharmacokinetic (PK) and immunogenicity assays.
• Experience implementing continuous quality improvement (CQI) activities.
• Proficiency in managing complex laboratory information systems.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with prescription benefits.
• 401(k) plan with company matching and flexible spending accounts.
• Paid vacation, sick leave, holidays, and parental leave.
• Company-paid short- and long-term disability and group life insurance.
• Perks including fitness club membership contribution, pet insurance, and identity theft protection.