Project Manager; Principal Investigator

Project Manager (Principal Investigator)

Job Category:
Operations

Requisition Number: EXPER
002256

Posted:
December 15, 2025 – Full‑Time

Ewing, NJ – 115 Silvia Street
West Trenton, NJ 08628, USA

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre‑clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, and perform the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA‑regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories.

Smithers PDS is seeking an experienced Project Manager (Principal Investigator) who will be the client’s primary point of contact and will oversee the overall conduct of the study. The Project Manager ensures deliverables are met on‑time, within scope, and within established quality standards. This position is salaried, classified as exempt, and typically requires 40+ hours to adequately perform responsibilities. Extended work hours may be necessary to support client deliverable commitments.

The role is generally eligible for a hybrid work schedule with at least three days on‑site once all training requirements have been met and consistent performance is demonstrated.

Salary range: $105,000 – $120,000 per year, commensurate with experience and qualifications. Benefits include a comprehensive health insurance package (three medical plans, dental, vision), 401(k) retirement plan, and PTO.

• Serve as the client’s primary point of contact and manage study conduct.
• Interpret, analyze, and report data for bioanalytical method development and validation.
• Manage pre‑clinical and clinical sample analysis using bioanalytical methods.
• Apply expertise in ligand‑binding assays (e.g., ELISA, MSD) and molecular biology assays (e.g., ddPCR, qPCR) for PK, biomarker, immunogenicity, and biodistribution studies.
• Integrate CRO business objectives into daily activities.
• Maintain knowledge of regulatory and GLP requirements, FDA guidelines, and industry standards for method validation and sample analysis.
• Mentor, train, or supervise new or less experienced team members.
• Participate in business initiatives such as process improvement, quality, and culture.
• Perform operational duties within appropriate experience and training.

• B.S./B.A. in Biology or related field and a minimum of 10 years of relevant CRO industry experience; or an advanced degree with at least 5 years of relevant experience.
• Knowledge of GLP regulations and regulatory guidelines.
• Excellent oral and written communication skills.
• Strong leadership and organizational skills.
• Proficient with MS Word and Excel.
• Ability to multi‑task and maintain quality under strict deadlines.
• Time‑management and resource‑planning proficiency.
• Self‑development initiative and decision‑making capability with minimal guidance.
• Proficiency with Watson LIMS preferred.
• Effective interaction at all organization levels, including clients and regulatory personnel.

Smithers PDS does not accept unsolicited third‑party candidate introductions, referrals, or resumes. In the event a third‑party recruiter submits a resume or refers a candidate without a previously signed vendor agreement, Smithers PDS reserves the right to pursue and hire the candidate(s) without financial liability to such recruiter.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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