Commercial Quality Control Chemist II

Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking an industry-experienced Commercial Quality Control Chemist to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications. Once the facility is underway, The Commercial QC Chemist II supports the Quality Control laboratory’s ongoing commercial product testing activities in support of cGMP practices, product quality, regulatory compliance, and customer satisfaction.

This position performs and provides technical expertise for commercial pharmaceutical testing, including finished facility testing, product release, stability, in-process control, raw material, and other analytical testing as assigned. The Commercial QC Chemist II serves as a technical resource for assigned analytical instrumentation, methods, and laboratory processes. The role supports analytical data integrity, laboratory investigations, method implementation, equipment qualification, and continuous improvement initiatives.

• May supervise QC laboratory staff continually or on a project basis.
• May assist with recruiting, interviewing, hiring, onboarding, and training new staff.
• May oversee the daily workflow, testing priorities, and execution of assigned commercial QC activities.
• May provide technical guidance, coaching, and support to QC Chemists I and other laboratory personnel.
• May assist QC management with workload planning, resource allocation, and meeting commercial testing timelines.

• Perform routine and non-routine analytical testing of commercial pharmaceutical products, including facility testing, finished product release, stability, in-process control, raw material, and other QC testing as assigned.
• Demonstrate intermediate expertise with applicable analytical equipment and techniques, including HPLC, GC, dissolution, Karl Fischer, XRPD, mDSC, UV-vis, FTIR, and other laboratory technologies as qualified.
• Execute approved analytical methods, compendial procedures, and laboratory SOPs in accordance with cGMP requirements, specifications, and established testing timelines.
• Ensure analytical data, calculations, laboratory records, and supporting documentation comply with Good Documentation Practices (GDocP), data integrity principles, and applicable regulatory expectations.
• Technical Data Review:
  Perform technical review of analytical data, calculations, and supporting documentation for commercial testing, as assigned and within established qualification and authorization.
• Serve as a technical resource for laboratory investigations, including OOS, OOT, deviations, incidents, and unexpected analytical results, in collaboration with QC management and Quality Assurance.
• Assist with root cause analysis, corrective and preventive actions, and implementation of improvements resulting from laboratory investigations.
• Support the transfer, implementation, verification, and optimization of analytical methods for commercial products, as assigned.
• Assist QC management with daily laboratory workflow, testing priorities, resource coordination, and timely completion of commercial testing deliverables.
• Interface with clients and internal stakeholders on technical analytical matters, testing status, data inquiries, and laboratory concerns, as requested by QC management.
• Assist with the development, revision, and technical review of SOPs, specifications, protocols, reports, and other controlled documents.
• Support the training, mentoring, and qualification of QC laboratory personnel on analytical methods, instrumentation, procedures, and GMP practices.
• Maintain compliance with cGMP, GDocP, data integrity, laboratory safety, and applicable regulatory requirements while promoting a culture of quality and accountability.
• Identify and support opportunities to improve laboratory efficiency, testing accuracy, turnaround times, equipment utilization, and right-first-time execution.
• Assist with internal and external audits, regulatory inspections, and preparation of supporting laboratory documentation and records.

• Demonstrates intermediate expertise with analytical equipment and techniques applicable to commercial pharmaceutical testing, including HPLC, GC, dissolution, Karl Fischer, XRPD, mDSC, UV-vis, FTIR, or other relevant technologies.
• Strong understanding of cGMP laboratory practices, Good Documentation Practices (GDocP), data integrity, and applicable…