Supervisor, QC Chemistry

About the role

The Supervisor, QC Chemistry, first shift is responsible for day-to-day supervision, audit readiness, and planning activities for the Chemistry laboratory.

Responsibilities

• Provide supervision and manage scheduling of the QC Chemistry team to ensure testing timelines are achieved.
• Ensure analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations.
• Perform, review, and provide expertise in physical and chemical analytical testing methods, including chromatography (HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis, ELSD), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, peptide mapping, and physical appearance per Standard Operating Procedures (SOPs) and test methods.
• Act as primary point of contact for the team and first-line escalation.
• Lead the team to meet project deliverables.
• Set up and maintain operations of a QC testing laboratory.
• Review and approve SOPs, protocols, reports, change controls, TrackWise deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Chemistry team, as needed.
• Assist senior management with resource planning and budget-related tasks.
• Gather recommendations for enhancements and gaps; collaborate with leadership to prioritize and implement solutions.
• Liaise with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results, as needed.
• Participate in cross-functional collaborations with other QC Departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Allocate and plan adequate resources for laboratory testing activities and QA support; provide technical guidance to the team.
• Lead cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based, right-sized approach.
• Lead or guide laboratory staff in investigating deviations/excursions and implementing CAPAs as needed.
• Serve as SME in audits and inspections; prepare and guide the laboratory team to ensure audit readiness.
• Collaborate with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements.
• Establish and maintain internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.
• Provide training, coaching, and mentorship; identify areas for improvement, reduce blind spots, and create growth opportunities aligned to career objectives.
• Perform other duties, as assigned.

Requirements

• Bachelor’s in Chemistry, Biochemistry, Biological Sciences, or related science field with 5+ years of experience; OR, Master’s in Chemistry, Biochemistry, Biological Sciences, or related science field with 3+ years of experience.
• 2+ years of team management experience.
• Analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO).
• 3+ years of experience working in a regulated GMP environment.
• Ability to guide and influence teams in a laboratory setting.
• Excellent oral and written communication skills.
• Experience in large pharma/biotech operations or projects.
• Knowledge and experience of physical and chemical analytical testing methods for biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LCMS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, peptide mapping, and physical appearance.
• Proven ability to lead teams.

Qualifications

• Experience managing complex projects.
• Experience with customer relationship management.
• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system).
• Working knowledge of LIMS, Smartsheet, TrackWise, and/or Kneat validation software.
• Experience and high-level familiarity/understanding of laboratory equipment, utilities qualification, environmental monitoring qualification, quality systems, automation, IT systems, and/or method validation.
• Experience in and thorough understanding of Data Integrity and application of regulatory requirements for QC assays.

Physical Requirements

• On a regular basis, the employee is required to discern audible cues.
• To stand for prolonged periods of time up to 240 minutes.
• To sit for prolonged periods of time up to 240 minutes.
• To conduct activities using repetitive motions that include wrist, hands and/or fingers.
• To conduct work that includes moving objects up to 10 pounds.
• To bend, push or pull, and reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• To work in warm/cold environments.
• To work in small and/or enclosed spaces.