Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and making sure our food is safe. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Information

Clinical Diagnostics Division in Middletown, VA. This position is for the 2nd shift, which typically starts between 2:00 and 3:00pm.

We are looking for an experienced Team Lead to oversee laboratory technicians, perform quality control testing, and manage team activities.

Major Responsibilities:

Team Leadership & Management:

Take on a leadership role within the team, laboratory protocols, and team leadership development to support business operations and quality outcomes.Guarantee that new employees undergo vital orientation and training following established procedures, aiding in their assimilation and triumph.Educate laboratory staff on laboratory protocols and equipment functionality, transferring expertise to improve team skills.Lead learning and education initiatives on Quality Assurance systems and Standard Operating Procedures (SOPs) to maintain compliance.Monitor, track, and provide feedback on employee performance through PMD process, supporting professional development.Provide coaching and corrective actions when needed to maintain performance standards and support team member growth.Supervise employee timekeeping and attendance following company guidelines, guaranteeing sufficient staffing and operational effectiveness.

Technical Operations:

Complete intricate analytical testing and review data with advanced proficiency, upholding the highest standards of scientific excellence.Lead OOS investigations and NCR/CAPA root cause analysis initiatives, driving continuous improvement in laboratory processes.Serve as subject matter expert on multiple analytical areas and instruments, providing technical guidance and support.Arrange QC laboratory testing schedules on a daily/weekly basis and distribute resources accordingly to meet departmental and plant requirements.Complete departmental data review for all sample types, ensuring compliance with specifications and procedures.

Quality Assurance & Process Improvement:

Identify issues, resource needs, and improvement opportunities within the laboratory to enhance efficiency and quality.Offer suggestions for resolution and process improvements, contributing to operational excellence initiatives.Monitor work area for unsafe conditions and take immediate action to correct unsafe conditions, maintaining a safe working environment.Ensure all laboratory activities align with cGMP, GLP, and ISO requirements to support regulatory compliance objectives.Complete spreadsheet validation training and oversee validation activities to maintain data integrity.Lead quality assurance initiatives and continuous improvement projects, driving innovation and efficiency.

Training & Development:

Provide advanced training and mentorship to laboratory employees, supporting professional growth and development.Devise and carry out training programs for laboratory practices and instruments, securing competence and adherence.Assess training needs and coordinate specialized training as required to maintain technical expertise.Assist team members in planning their career development, nurturing a culture of progress and promotion.Stay updated on industry guidelines and regulatory requirements, sharing insights with the team.

Administrative Responsibilities:

Supervise daily work tasks and priorities for team members to improve workflow and productivity.Arrange staff schedules to ensure ample coverage for meeting operational commitments.Participate in performance evaluations and development planning, supporting team member success and retention.Uphold documentation and records in alignment with regulatory standards and GMP requirements.Assist in budget planning and determining resource allocations to enhance the efficiency of laboratory operations.

Minimum Requirements/Qualifications:

Bachelor's degree or equivalent experience in Biology, Chemistry, Medical Technology, or a related scientific field.5-7 years of laboratory experience within the pharmaceutical/biotechnology industry preferred.2-3 years of supervisory or team leadership experience in a laboratory setting preferred.Proficient in analytical testing methods with excellent problem-solving skills.Familiarity with regulatory conformity (cGMP, GLP, FDA, ISO) within the pharmaceutical/biotechnology sector.Experience in training, coaching, and developing laboratory personnel.

Knowledge, Skills, AbilitiesFamiliarity with clinical laboratory equipment alongside adept problem-solving abilities.Demonstrate proficiency in analytical testing methods and have strong problem-solving skills.Ability to organize and prioritize team workload and manage multiple projects simultaneously.Familiarity with cGMP and ISO standards, coupled with a background in regulatory settings.Knowledge of network and Microsoft Office computer applications, including advanced Excel skills.Ability to handle multiple team responsibilities with competing priorities and stay well organized.Ability to work extra hours or modify schedules as necessary to accommodate operational requirements.Excellent oral and written communication skills for effective team leadership.Ability to collaborate with all departments and external collaborators as team representative.Physical Requirements / Work EnvironmentNormal laboratory/office environment.Position may require frequent communication and walking to other areas in which designated PPE will be required.Position will require sitting and standing for extended periods.Employee may occasionally lift and/or move up to 45 pounds.