Smithers PDS LLC (Pharmaceutical Development Services) assists in the development of new medicines by providing bioanalytical services for all phases of drug development from discovery through approval and post market surveillance. PDS works with customers to develop new methods, validate existing methods, and perform the assays necessary to analyze samples from patients on more than 100 clinical trials. PDS is seeking a Laboratory Supervisor to join our Gaithersburg, MD team. The successful candidate is able to apply prior experience and knowledge to successfully perform in a laboratory environment under regulated conditions.

SCOPE OF POSITION:

This position is responsible for supervising a team of technical employees providing bioanalytical laboratory support services. Supervision responsibilities include scheduling tasks, providing direct oversight and daily work instructions, monitoring technical capacity, identifying training needs, providing training, approving timesheets, writing and conducting employee performance reviews, compiling performance metrics to senior management and upholding all safety and regulatory standards.  

The supervisor will work closely with the department manager/director and human resources to properly address any employee performance issues.  The incumbent will develop a highly efficient, profitable, and quality oriented team, while providing subordinates with opportunities for professional growth.   

ESSENTIAL RESPONSIBILTIES:

• Work with other supervisors to schedule resources to meet client deliverables.
• Attend study meetings and consult with project managers to ensure project requirements are understood and are communicated to staff.
• Ensure schedules are prepared and disseminated to staff and work is adequately executed.
• Build a team of technical resources able to flex between various service lines as needed.
• Identify and addresses training needs throughout the team.
• Review and verify data and documentation generated by other staff as assigned.
• Upholds all safety and regulatory standards.
• Monitor capacity (people and equipment) within the team and works across teams as necessary to supplement capacity gaps.
• Contributor in the execution of project work when necessary.
• Create culture that values teamwork and holds people accountable.
• May be asked to serve on internal ad hoc committees.
• Works with Department and HR leader to address team talent needs including hiring, training, advancing, appraising, motivating, disciplining, and assuring healthy and safe working conditions of staff members.
• Responsible for ensuring the appropriateness of time and materials charged to projects.
• Implements and observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) requirements, study protocols, and analytical plans.
• Serves on Site Safety Committee, implements and observes appropriate safety and health practices including personal protective equipment (PPE) and safe laboratory practices.
• Performs work under regulated conditions (GLP, GCP, CLIA) as required.
• Perform other duties as may be required.

SUCCESS ATTRIBUTES:

• Actively seeks out and participates in both formal and informal training opportunities to continuously develop interpersonal, technical, and professional skills
• Takes on new challenges and responsibilities to achieve functional, organizational, and personal goals, all while modeling the Smithers Ethics, Mission, Employees, Me (EMEM) values
• Communicates with team members at all levels effectively and appropriately
• Exhibits a demeanor conducive to good relations with multiple stakeholders; must be able to effectively collaborate with internal teams
• Actively seeks guidance where appropriate and when assistance is required; solicits input/feedback

 EDUCATION & EXPERIENCE REQUIREMENTS: 

• BA/BS in biological or physical Sciences and at least 7 years of relevant experience; or,
• MS in biological or physical sciences and at least 5 years of relevant experience.
• Must have prior experience as a direct supervisor.
• Must have at least 3 years prior experience working in a GLP environment.
• Experience and knowledge of Ligand-binding assays (e.g. ELISA/MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies is required.
• Ability to work safely with potentially hazardous substances and exercise universal precautions.
• Work requires some standing and sitting for long periods of time, including working within a laboratory hood or at a laboratory bench.
• Expert pipetting skills.
• Knowledge of Watson LIMS a plus.

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