Laboratory Operations Manager
POSITION TITLE: Laboratory Operations Manager / Exempt
LOCATION: Baltimore, MD
REPORTS TO: Vice President of Research
PRIMARY OBJECTIVES: Manage the daily scientific operation, schedule and function of the laboratory in the Personalized Oncology Services (POS), Translational Oncology Services (TOS), banking and research and development departments. Lead the audits for regulatory and sponsor audits of the facility and studies.
.DUTIES AND RESPONSIBILITIES
- Manage the day – to – day scientific operations of the laboratory; arrange for adequate staffing at all times; monitor daily operations to ensure all SOP’s are being followed.
- Monitor in vivo studies for the Company.
- Review the design of POS, TOS and TOS R&D study protocols in collaboration with the Project Managers.
- Understand and ensure staff follow all SOP’s and Quality Assurance Standards.
- Create, maintain, and review laboratory-related SOPs to ensure they reflect current work practices.
- Lead the audits for regulatory and sponsor audits of the facility and studies.
- Assist with the operational supervision of the propagation and maintenance of TumorGraft banks.
- Supervise Dose Formulation Technicians and Research Associates within the lab.
- Ensure the proper training and competency of laboratory staff.
- Provide input into hiring and firing decisions; conduct performance appraisals and provide counseling when needed.
- Assist with other tasks/duties as need in a small company environment
KNOWLEDGE, SKILLS AND ABILITIES
- Experience in preclinical in vivo pharmacology studies in the mouse: efficacy studies, MTD, MOA, and PK/PD studies. Experience with oncology studies preferred
- Scientific oversight and project management experience.
- Knowledge of and experience in animal welfare and state and federal regulations regarding preclinical studies (AALAC and CLIA).
- Demonstrated ability to work effectively and productively in a team-oriented environment while maintaining a strong sense of integrity and confidentiality.
- Possess creative problem solving skills and the ability to exercise sound and accurate judgment in making timely decisions.
- Possess superior planning, organizational, computer, written and verbal communication skills and the ability to network and negotiate effectively.
- Ability to be flexible and assist with other tasks/duties as needed in a small company environment.
- Demonstrated accountability and responsibility for own work.
- Ability to observe safety and security procedures.
EDUCATION AND EXPERIENCE
- BS degree in biology, pharmacology or related field. MS or Ph.D. preferred.
- Knowledge and understanding of the working of a contract research organization.
- Experience in project management.
- Experience with Laboratory Information Management Systems (LIMS) software. Experience with Provantis a plus.
- Minimum 4 years of experience in contract research animal facility devoted to preclinical and/or oncology drug testing with advancement to supervisor and/or manager preferred.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Must be able to sit and use hands to finger, handle and feel
- Must be able to lift and move packages weighing up to 50 pounds.
- Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility.
- Some activities require repetitive motion and reaching, pulling or pushing.
- In carrying out the duties of the job there will be frequent exposure to fumes and chemical hazards.
- Duties performed routinely require exposure to blood, body fluid and tissue.
This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.
- Competitive compensation and benefits
- Committed team environment
- Daily interaction with the world’s leading experts in cancer treatment