Associate Project Manager or Project Manager

Smithers Careers•Gaithersburg, MD

14h•Hybrid

About The Position

Smithers PDS LLC (Pharmaceutical Development Services) provides pre-clinical and clinical services across all phases of drug development. 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, ensuring deliverables are completed on time, within scope, and to established quality standards. The position may serve as Principal Investigator for GLP studies and involves interpreting, analyzing, and reporting results for biopharmaceutical product validation and sample analysis. The role also supports business development, advises scientific staff, forecasts revenue, and prepares and revises SOPs. The position is classified as exempt and paid on a salary basis. Exempt employees typically work 40 hours or more to fulfill their responsibilities, and extended hours may be necessary to meet client commitments. The position is generally eligible for a hybrid schedule, with at least three days on-site after training requirements are met and proficient performance is consistently demonstrated. The 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’s 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.
Understanding of contract immunoanalytical business objectives.
Familiarity with regulatory and GLP requirements, FDA guidelines, and industry standards for bioanalytical method validation.
Knowledge of GLP regulations and regulatory guidelines.
Excellent oral and written communication skills.
Strong leadership and organizational skills.
Proficiency with basic computer applications, including 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.
Ensure study deliverables are completed on time, within scope, and within established quality standards.
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.