Project Manager; Principal Investigator

Project Manager (Principal Investigator)

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.

This position is salaried and classified as exempt. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting 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 proficient performance is consistently demonstrated.

Salary range: $105,000 – $120,000 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of three medical plans, dental insurance, vision insurance, a 401(k) retirement plan, and PTO.

• Serve as the client’s primary point of contact and oversee the overall conduct of the study.
• Interpret data, analyze results, and prepare reports for bioanalytical method development and validation.
• Manage pre‑clinical and clinical sample analysis using bioanalytical methods.
• Apply knowledge of ligand‑binding assays (e.g., ELISA/ MSD) and molecular biology assays (e.g., ddPCR, qPCR) for Pharmacokinetic, Biomarker, Immunogenicity, and biodistribution studies.
• Integrate bioanalytical contract research organization (CRO) business objectives into daily activities.
• Maintain knowledge of regulatory and GLP requirements, FDA guidelines, and industry standards for bioanalytical method validation and sample analysis.
• Mentor, train, or supervise new or less experienced team members as needed.
• Contribute to business initiatives such as process improvement, quality, and culture.
• Perform operational duties in areas of appropriate experience and training.

• B.S./B.A. in Biology (or related field) with a minimum of 10 years of relevant CRO industry experience; or an advanced degree in Biology (or related field) 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.
• Advanced proficiency in basic computer applications such as MS Word and Excel.
• Ability to multi‑task and deliver quality analysis under strict deadlines.
• Proficiency in time management and resource planning.
• Initiative to pursue self‑development efforts.
• Knowledge of Watson LIMS is preferred.
• Effective interaction at all levels of the organization, with clients and regulatory personnel.
• Decision‑making capability and ability to complete assignments with minimal guidance.
• Ability to establish work priorities and manage shifting priorities.

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 third‑party recruiter.