QC Laboratory Supervisor

Overview: The QC Laboratory Supervisor for Radiopharmaceutical Contract Manufacturing at NJ5 is responsible for

supervising the Quality Control laboratory and chemist team and ensuring timely analysis of therapeutic

radiopharmaceuticals under 21 CFR 211 and Eudralex Volume 4. Following SOFIE''''s QA program and cGMP guidelines,

they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements. The Laboratory

Supervisor will typically oversee a designated shift of chemists.

Compensation Range | $115,000 - $125,000

Essential Duties and Responsibilities

Lead laboratory and team with agility and empowerment prioritizing Safety, Quality, and Right First Time for

product release. Serve as a laboratory trainer to train new hires and existing teams on testing methods,

techniques and instruments to make them independent in performing laboratory testing.

Conduct routine 1:1 and annual performance review for the direct reports. Serve as a mentor and coach team as

necessary for growth and career progression. Support QC leadership to set annual goals as necessary for the

direct reports.

Proactively work with production management and project management to get daily, weekly and monthly priorities

and timeline for completion. Schedule routine and non-routine laboratory work based on priority and required

timelines, resource and equipment availability and utilization across the trained and qualified team. Communicate

effectively, the ongoing status, both internally and cross functionally through email, meetings, and or Tier

meetings as scheduled.

Acting as a working (hands-on) supervisor, conduct required Quality Control analytical tests and performs batch

record review for QC releases of regular production of radiopharmaceuticals for preclinical or clinical use

according to cGMP standards. Partner with clients to serve as a project lead where necessary.

As a working supervisor, participate in analytical method validation activities.

Collaborate with production radiochemists as required to ensure successful protocol development and

radiopharmaceutical production.

Supervise and lead the RCM QC laboratory chemist team in the analysis of radiopharmaceuticals for

development, clinical trials, or commercial manufacturing. Support troubleshooting and problem-solving activities

as required during the analysis.

Enable teams of chemists to work efficiently increasing laboratory productivity and organizing workspace using 5S

and Waste Elimination technique. Identify improvement projects and lead projects through completion.

Participate and lead internal, customer and regulatory audits. Ensure that laboratory and team are always Audit

Ready.

Assist laboratory management for tracking and driving daily Laboratory Metrics. Assist with evaluation of Key

Performance Indicator for laboratory performance and enhancement of Quality, Safety and Deliverables within the

scope of Quality Control department.

Contribute to the generation of regulatory documentation required for new radiopharmaceuticals, including

Standard Operating Procedures (SOPs), and QC Records.

Lead laboratory Change Control and CAPA process from initiation and following through completion of all actions

to ensure on time closure as required per SOFIE's change control procedure.

Lead laboratory Out of Specification, and Deviation process from initiation and following through on timely

closure. Perform root cause analysis and as necessary utilize FMEA, Fishbone Diagram and 5 Whys technique

during the investigation process. Collaborate with cross-functional team, Clients and Vendors for resolution per

SOFIE's as required.

Write clear Standard Operating Procedures (SOPs).

Lead Laboratory for existing and upcoming QMS projects to implement LIMS, Trackwise, etc., as necessary.

Provide oversight into the material acceptance process for critical raw materials, including developing

specifications, coordinating outsourced testing, material acceptance for use, etc.

Lead and oversee the installation, qualification, and maintenance of laboratory equipment on site. Coordinate with

metrology and engineering and vendor to ensure on time conformation status of each QC equipment.

Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and

pharmaceutical regulations.

Maintain accurate radiopharmaceutical production records and test/validation results.

Write reports, presentations, and other documentation summarizing data.

Coordinate with the Radiopharmaceutical Contract Manufacturing team''''s activities to reach defined objectives.

Liaise with our contract partners (e.g., biotech and pharma).

Serve as a deputy to laboratory manager and or existing laboratory leadership.

Perform other duties as assigned.

Qualifications

Bachelor's degree in chemistry or natural science required with 8+ years of experience in analytical chemistry and

instrumentation (qualification, troubleshooting and maintenance) required; a Master's degree with 6+ years of

experience is preferred. 2-4 years of staff supervision or management experience is required Experience as a

team or process lead will be considered as part of leadership experience.

Experience in a GMP manufacturing environment is highly preferred.

Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC,

HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.)

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and

procedure manuals required.

Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification

required.

Some knowledge of pharmaceutical microbiology is preferred.

Efficient in the use of MS Office Suite required.

Excellent organizational skills required.

Experience or knowledge of Lean Six Sigma Methodologies is preferred.

Ability to work assigned and potentially varying shifts and weekends required