Supervisor, QC Chemistry

Fujifilm•Holly Springs, NC

4d•Onsite

About The Position

The Supervisor, QC Chemistry, first shift is responsible for day-to-day supervision, audit readiness, and planning activities for the Chemistry laboratory. This Supervisor will lead a team responsible for performing routine testing of QC analytical chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, peptide mapping, and physical appearance.

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.

Nice To Haves

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.

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.