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, as well as performing 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 responsible for being the client's primary point of contact and for 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 and is classified as an exempt position. 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. Position is generally eligible for a hybrid work schedule with at least three days on-site once all training requirements have been adequately met and proficient performance is consistently demonstrated.

Salary range for this position is $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 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO.

Essential Position Responsibilities:

• Responsible for client interaction and the conduct of studies.
• Responsible for data interpretation, analysis, and reporting of results for bioanalytical method development and validation.
• Responsible for the management of preclinical and clinical sample analysis using bioanalytical methods.
• Maintains and applies experience and knowledge of ligand-binding assays (e.g. ELISA / MSD) or molecular biology assays (e.g. ddPCR, qPCR) applicable to Pharmacokinetic, Biomarker, Immunogenicity, biodistribution studies to support existing and new client studies.
• Integrates bioanalytical contract research organization (CRO) business objectives in daily activities.
• Maintains knowledge and applies regulatory and GLP requirements, FDA guidelines, and industry standards for bioanalytical method validation and sample analysis.
• May mentor, train, or supervise new or less experienced team members.
• Participates in or contributes to business initiatives, such as process improvement, quality, culture, etc.
• May perform operational duties in areas of appropriate experience and training.

Minimum Qualifications:

• B.S. / B.A. degree in Biology or related field and a minimum of 10 years of relevant experience in the CRO industry; or, advanced degree in Biology or related field and at least 5 years of relevant experience in the CRO industry.
• Knowledge of GLP regulations and regulatory guidelines.
• Excellent communication skills, both oral and written.
• Strong leadership and organizational skills.
• Excellent organizational skills.
• Proficient in the use of basic computer applications such as MS Word and Excel.
• Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.
• Proficient in time management and resource planning.
• Ability to initiate and implement self-development efforts.
• Knowledge of Watson LIMS preferred.
• Ability to effectively interact at all levels of the organization in addition to with clients and regulatory personnel
• Ability to make decisions and complete assignments with minimal guidance.
• Ability to establish work priorities and manage shifting priorities.

Smither 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.

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