Associate Project Manager or Project Manager

Smithers•Gaithersburg, MD

1d•$87,500 - $130,000•Hybrid

About The Position

Smithers PDS LLC (Pharmaceutical Development Services) provides pre-clinical and clinical services across all phases of drug development, including large-molecule bioanalysis, assay development, validation, and sample analysis in GLP-, GCP-, and CLIA-compliant laboratories. The Associate Project Manager or Project Manager serves as the client's primary point of contact and is responsible for the overall conduct of studies. The position ensures deliverables are completed on time, within scope, and to established quality standards. The position is classified as exempt and paid on a salary basis. Exempt employees typically work 40 hours or more as needed to fulfill their responsibilities, and extended hours may be necessary to meet client deliverables. A hybrid schedule is generally available after training requirements are met and consistently proficient performance is demonstrated; it requires at least three days on-site. The stated annualized salary range is $87,500–$112,500 for an Associate Project Manager or $105,000–$130,000 for a Project Manager. Experience and qualifications determine salary and job level.

Requirements

Bachelor of Science or Bachelor of Arts degree in Biology or a related field and at least 5 years of relevant CRO industry experience, or an advanced degree in Biology or a related field and at least 2 years of relevant CRO industry experience.
Experience and knowledge of ligand-binding assays (ELISA/MSD) applicable to pharmacokinetic, biomarker, and immunogenicity studies.
Knowledge of GLP regulations and regulatory guidelines.
Understanding of contract immunoanalytical business objectives and familiarity with regulatory and GLP requirements, FDA guidelines, and industry standards for bioanalytical method validation.
Excellent oral and written communication skills.
Strong leadership and organizational skills.
Proficiency with basic computer applications, such as MS Word and Excel.
Ability to multitask and produce quality analysis under strict deadlines.
Proficiency in time management and resource planning.
Ability to initiate and implement self-development efforts.
Ability to interact effectively 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.

Responsibilities

Serve as the client's primary point of contact and oversee the conduct of studies.
Serve as Principal Investigator for GLP studies.
Interpret and analyze data, and report results for validation and sample analysis of biopharmaceutical products.
Support business development activities.
Provide technical advice to scientific staff.
Forecast revenue.
Prepare and revise SOPs.
Ensure study deliverables are completed on time, within scope, and within established quality standards.