GLP Biologics Bioanalytical SME
Salary: 150000 - 190000
Location: Rockville, MD
Posted: December 02 2024
Minimum Degree:
Relocation Assistance: Available
GLP Biologics Bioanalytical SME
~ Onsite in Rockville, MD ~
You will oversee a growing bioanalytical team and ensure GLP and GCP compliance.
You will serve as an SME and offer guidance in both operations and strategy.
You will direct projects and ensure compliance and satisfaction.
Key Responsibilities:
1. Lead complex bioanalytical projects under GLP/GCLP regulations, managing method validation studies while ensuring compliance and proper documentation.
2. Provide technical oversight and mentorship to laboratory staff, including training, performance management, and guidance on analytical procedures.
3. Interface with internal and external clients to define project scope and requirements while serving as primary point of contact for deliverables and timelines.
4. Drive continuous improvement through process optimization and implementation of departmental strategies.
5. Review and approve analytical data and technical reports while ensuring data integrity and maintaining quality standards.
Experience:
· 10+ years of progressive experience in bioanalytical testing, including hands-on work with immunoassays and ligand-binding assays in a regulated environment.
· 4+ years of supervisory experience demonstrating effective team leadership and performance management.
· Proven track record in high-complexity, high-throughput laboratory operations.
· Demonstrated experience in GLP/GCLP regulated environments.
Qualifications:
· PhD in Biology, Chemistry, or related scientific discipline.
· Advanced knowledge of bioanalytical laboratory principles, including expertise in technical troubleshooting and complex problem-solving.
· Strong project management skills with demonstrated ability to work independently and lead multiple concurrent studies.
· Exceptional communication and interpersonal skills, including technical writing and cross-functional collaboration abilities.
Additional Points:
-- This is a full-time position at the Principal Scientist level.
-- Competitive compensation package includes base salary plus annual bonus.
-- This role is based in Maryland, with a comprehensive relocation package available.