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Director, Bioanalytical Laboratory (Medtech)
14 508 - 22 675$
Job description
Text:
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
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.