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Project Manager - GLP Lab

Project Manager - GLP Lab

ID 
2018-1191
Category 
Research
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Project Manager, GLP Lab is responsible for the effective management (planning, budgeting, forecasting, and scheduling) of all aspects of bioanalytical testing programs that supports MacroGenics’ preclinical and clinical drug development studies. He/she will ensure adherence to GLP compliance and regulations, accurate budget management and resource forecasting, timely and flawless execution of projects. He/she is expected to create and foster healthy and collaborative relationships by partnering closely with clinical operations teams, research, lab scientists and Quality Assurance.

 

Responsibilities and Job Duties:

  • Partners with clinical, research, quality assurance and other departments as appropriate; plans and allocates resources to ensure that testing needs for each study are met and handled in an optimal and efficient manner. 
  • Develops budgets for new and existing GLP testing programs by partnering with clinical operations team and research. 
  • Manages GLP lab budget forecasts; develops cost estimates, forecasts GLP testing program budgets and keeps them up-to-date. 
  • Builds realistic program timelines, identify the critical path, ensures that all parties are aware of short-term deadlines and long-term goals, and keeping each testing program on schedule. Proactively raises potential issues and assists with facilitating the resolution of problems. Provides detailed timeline information to assist planning and resource allocation and tracks and monitors timeline performance to assist in future forecasting efforts.
  • Monitors and tracks progress to ensure that all projects are delivered on-time, within budget and within scope. Identifies/anticipates issues and work with stakeholders to determine a resolution.
  • Manages the test scheduling for both clinical and nonclinical studies to ensure timely and flawless execution. 
  • Manages data reconciliation with clinical and research teams.
  • Oversees the GLP laboratory equipment lifecycle; works closely with vendor, facility, validation and quality assurance to ensure all the equipments are qualified for using in GLP studies; 
  • Ensures the compliance of GLP lab’s daily activities, including but not limited to lab records for the all reagents, test samples and lab equipment; works closely with QA Manager to support quality audits, and ensure corrective actions are taken to address any concerns or issues raised from the audits. 
  • Serves as a backup LIMS administrator to support GLP testing. Responsibilities may include maintaining user security, performing system maintenance, configuring new Master Data, troubleshooting, conducting training for new staff etc. 
  • Develops and executes Standard Operating Procedures (SOPs) covering instrument, test sample and reagent management and refines as needed.
  • Collaborates with Clinical Operation, QA and research staff. 

Qualifications

Education & Credentials

  • Bachelor degree in life sciences

Experience

  • Minimum five years of experience in a regulated environment 
  • Minimum four years of experience working in a clinical or biological laboratory 
  • At least two years of project/program management experience

Knowledge, Skills and Abilities

  • Working knowledge of GxP regulations
  • Knowledge and working experiences with LIMS
  • Ability to influence without direct authority
  • Results driven with demonstrated successful outcomes
  • Ability to handle multiple tasks and priorities in a fast-paced environment with awareness of deadlines
  • Ability to coordinate multiple group efforts within the company to achieve objectives
  • Excellent communication and facilitation skills
  • Proficiency with word processing, spreadsheet, database, and presentation software
  • Detail oriented with the ability to work independently

Supervisory Responsibilities

  • Could have up to two direct reports in the future 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.