Associate Project Manager or Project Manager

Smithers Careers•Gaithersburg, MD

9d•Hybrid

About The Position

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 Associate Project Manager or Project Manager who will be responsible for being the client's primary point of contact and for the overall conduct of the study. The role ensures deliverables are met on-time, within scope, and within established quality standards. This position is classified as exempt and paid on a salary basis. 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.

Requirements

Experience and knowledge of Ligand-binding assays (ELISA / MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies is required.
Must understand contract immunoanalytical business objectives and is expected to be familiar with regulatory, and GLP requirements, FDA guidelines and industry standards for bioanalytical method validation.
B.S. / B.A. degree in Biology or related field and a minimum of 5 years of relevant experience in the CRO industry; or, advanced degree in Biology or related field and at least 2 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 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.
Ability to effectively interact with clients and regulatory personnel.
Ability to make decisions and complete assignments with minimal supervision.
Ability to self-direct work priorities.

Nice To Haves

Knowledge of Watson LIMS a plus.

Responsibilities

Responsible for client interaction and the conduct of studies.
Serve as Principal Investigator for GLP studies
Responsible for data interpretation, analysis, and reporting of results for validation and sample analysis of biopharmaceutical products.
Support business development activities.
Provide technical advice to scientific staff.
Forecast of revenue, preparing and revising SOPs.