Responsibilities:
- Oversee analytical team/s to ensure effective, timely, efficient operations and compliance with GLP/cGMP requirements.
- Lead a culture of teamwork and operational excellence; embed company values.
- Develop and report KPIs for Lab Operations performance; drive continuous improvement using operational excellence tools.
- Hire, mentor, and develop team members; provide coaching and developmental feedback.
- Approve investigations and create meaningful CAPA to improve lab performance.
- Foster collaboration/communication across shifts and with Technical Operations team members.
- Perform other tasks as required to support analytical laboratories.
Qualifications:
- Bachelorβs degree (or equivalent), preferably in science; Advanced Degree preferred.
- 10+ years relevant laboratory work experience, preferably in regulated environments.
- Experience with bioanalytical techniques: cell-based assays, ELISA, qPCR, flow cytometry (and related equipment).
- 4+ years leadership experience managing direct reports.
- Knowledge of LIMS, ELN, and laboratory data analysis systems (preferred).
- Strong analytical, problem-solving, and critical thinking skills; data handling and applied statistics.
- Experience with Quality Management Systems (Deviations, CAPAs, Change Management).
Preferred Qualifications:
- Manufacturing and quality testing experience for cell therapies and/or product life cycle management.
- Experience managing direct technical staff.
Compensation (range): $135,770β$164,522 (Summit West, NJ, US).