Night Shift Supervisor, SQC In-Process

The Syracuse Quality Control (SQC) Laboratories support the onsite small scale commercial manufacturing facility, as well as network and third party manufacturing facilities. The SQC Supervisor provides operational and technical support to the QC laboratory by enabling continued daily laboratory operations to meet customer needs.

This position is responsible for providing technical leadership in an area of expertise in a functional area to the night shift SQC In-Process teams. The expertise may include Bioseparations or In-Process testing for in-process, release and/or stability testing. A variety of duties are performed relating to the lean and effective functioning of SQC laboratories. This role is responsible for leading, driving and providing both operational and technical oversight of laboratory testing, technical projects and studies in a compliant manner. In addition, this role will communicate with internal and external customers.

Duties/Responsibilities:

• Assist with management of the day to day activities and prioritization of work.
• Develop/maintain processes in SQC laboratories to support cGMP compliant testing.
• Accurately document laboratory work and instruct other less experienced on good documentation practices.
• Perform routine data analysis and author investigation reports, and perform data trending analyses.
• Recognize anomalous trends or results within realm of experience and training.
• Mentor junior staff.
• Facilitate technical transfer and co-validation activities for test methods.
• Review or write technical protocols and reports.
• Perform basic troubleshooting of lab instrumentation. Have ability to recognize instrumentation issues and resolve them based on prior experience.
• Drive communication to ensure employees know what is required from shift to shift.
• Modify SOPs as required.
• Demonstrate on-going proficiency in the performance and theoretical understanding of a broad range of assays.
• Review assay data based on demonstrated proficiency in assay within realm of experience and training.
• Able to recognize atypical results and trends within the realm of experience and training and follow-up as needed.
• Be recognized by peers as an in-house expert for assays in area of expertise.
• Collaborate with appropriate laboratory and manufacturing personnel to ensure needs and requirements are accurate.
• Review method/specification changes and work with staff to communicate updates.
• Ensure staff training is current.
• Train users and less experienced team members on use of QC systems.
• Provide ad hoc customer support.
• Maintain up to date knowledge on current SQC lab software applications.
• Become a qualified trainer for area of expertise.
• Develop job function training.
• Ensure Lean practices within lab for continuous improvements to efficiency.
• Partner with Quality Assurance to perform laboratory investigations, determine root cause for laboratory errors, and identify appropriate corrective/preventive actions for laboratory errors.
• Lead/Participate on teams in support of business process improvements/operational excellence.
• Facilitate positive culture change with implementation of new processes.
• Provide leadership to staff through demonstration of a quality culture and scientific excellence.
• Present information at group/department meetings.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc.:

• Previous hands-on training and GMP experience within the laboratory setting
• Expert level applied knowledge and in depth understanding of analytical techniques preferred.
• Demonstrated leadership ability.
• Self-directed with a high degree of professional integrity, very organized, and detail-oriented.
• Excellent problem solving ability, attention to detail, and analytical/critical thinking skills.
• Ability to prioritize objectives from multiple project, adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
• Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
• Proficient with Microsoft Office Applications (Excel, Project, PowerPoint, Word) and/or other relevant software programs.
• Demonstrated ability to effectively train and assist other less experienced individuals.

Education/Experience/Licenses/Certifications:

Minimum B.S. degree in a scientific area with 8 to 10 years' experience, M.S. degree with 4 years' experience. Experience is required working in a cGMP laboratory.

Work Environment:

This position is a lab-based position which requires appropriate levels of personal protective equipment (PPE).

This role will require:

• Contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics.
• Powdered materials and high temperature liquids and solids may also need to be handled.
• Use of instrumentation that includes lasers may be required.
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching is required.
• This role also requires frequent unassisted lifting (not to exceed 50 lbs).
• Repetitive use of arms/hands/wrists and grasping is also required.
• Depending on the work demands, office-based work requires sitting.
• This position is based indoors and primarily requires working with others, but also independent/alone work at times.
• This position is a team-based position that requires shift work, weekends, and holidays.

Travel:

This position may require minimal travel for trainings and/or meetings.

Supervisory Responsibilities:

The position will to support the night shift teams and will provide coverage for supervisory functions on an as needed basis. These functions include, but are not limited to, running the team huddle meetings, scheduling team activities and providing direction/support to team members.