Hybrid Associate Project Manager - GLP Study Lead

Smithers - Medical Device Testing; Gaithersburg (MD); Hybrid; USD 88,000 - 130,000; Full time

Job summary

Smithers PDS LLC (Pharmaceutical Development Services) seeks an Associate Project Manager or Project Manager to be the client’s primary contact and oversee studies. The role ensures on-time, within-scope deliverables and maintains established quality standards, with exempt status and a hybrid schedule requiring on-site work three days per week after training.

Responsibilities include acting as PI for GLP studies, data interpretation and reporting, supporting business development, and providing

Qualifications

• B.S./B.A. degree in Biology or related field with 5+ years CRO experience; or advanced degree with 2+ years
• Knowledge of GLP regulations and regulatory guidelines
• Excellent communication skills, both oral and written; strong leadership
• Proficient in MS Word and Excel

Responsibilities

• Client interaction and conduct of studies.
• Serve as Principal Investigator for GLP studies.
• Data interpretation, analysis, and reporting of results for validation and sample analysis.
• Support business development activities.
• Provide technical advice to scientific staff.
• Experience with ligand-binding assays (ELISA/MSD) for PK, biomarker, and immunogenicity studies.
• Familiarity with regulatory and GLP requirements, FDA guidelines and industry standards for bioanalytical method validation.
• Knowledge of Watson LIMS a plus.
• Forecast revenue and assist in revising SOPs.

Skills

Client interaction

Communication

Leadership

Education

B.S./B.A. in Biology or related field

Advanced degree in Biology or related field

Tools

MS Word

Excel

Job description

Smithers PDS LLC (Pharmaceutical Development Services) seeks an Associate Project Manager or Project Manager to be the client’s primary contact and oversee studies. The role ensures on-time, within-scope deliverables and maintains established quality standards, with exempt status and a hybrid schedule requiring on-site work three days per week after training.

Responsibilities include acting as PI for GLP studies, data interpretation and reporting, supporting business development, and providing