Associate Project Manager or Project Manager

Smithers Group; Gaithersburg, Northern (MD, KY); Hybrid; USD 88,000 - 130,000; Full time

Job summary

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.

Qualifications

• BS/BA in Biology or related field; 5+ years CRO experience.
• Advanced degree in Biology or related field with 2+ years CRO exp.
• Familiar with GLP regulations and FDA guidelines.
• Strong communication and leadership abilities.

Responsibilities

• Interact with clients and oversee study conduct.
• Serve as Principal Investigator for GLP studies.
• Interpret data, analyze and report results for validation.
• Provide technical advice to scientific staff.
• Experience with ELISA/MSD in PK, Biomarker, or Immunogenicity studies.
• Understand regulatory, GLP, FDA guidelines; know Watson LIMS is a plus.
• Forecast revenue and assist with SOP development.

Skills

Communication skills

Leadership

Organizational skills

Multi-tasking

Education

BS/BA in Biology or related field

Advanced degree in Biology or related field

Tools

MS Word

Excel

Watson LIMS (plus)

Job description

Associate Project Manager or Project Manager

Job Category : Operations

Requisition Number : ASSOC002389

• Posted : September 3, 2026
• Full-Time
• Hybrid

Locations

Showing 1 location

Gaithersburg, MD 20878, USA

Description

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.

The annualized salary range for an Associate Project Manager or Project Manager position is $87,500 -112,500 or $105,000 - $130,000, respectively. Experience and qualifications will determine salary and job level. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO.

• 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.
• Provide technical advice to scientific staff.
• 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.
• Knowledge of Watson LIMS a plus.
• Additional responsibilities include forecast of revenue, preparing and revising SOPs.

Minimum Qualifications

• 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.

Additional Position Requirements

• 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.

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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