QC Supervisor – Analytical Chemistry
Location: Horsham, PA - Onsite
About the Opportunity
Join a highly respected pharmaceutical contract development and manufacturing organization (CDMO) located in the Horsham, Pennsylvania area.
This privately held organization has more than three decades of success supporting leading global pharmaceutical companies and is recognized for its exceptional quality standards, strong regulatory history, and investment in advanced laboratory technology. The company offers a collaborative, science-driven environment where scientists work directly with clients on innovative drug development programs spanning early-stage development through commercial manufacturing.
Position Summary
The QC Supervisor – Analytical Chemistry will provide technical and day-to-day leadership within the Quality Control laboratory while remaining actively engaged in analytical testing and laboratory activities.
This is a hands-on leadership role for an experienced analytical chemist who enjoys both technical problem-solving and developing people. The Supervisor will oversee laboratory activities, provide guidance and mentorship to QC analysts, review analytical data and documentation, support method development and validation, and help ensure testing is completed accurately, efficiently, and in accordance with cGMP and regulatory requirements.
The ideal candidate brings strong pharmaceutical analytical experience, a solid understanding of laboratory compliance, and the ability to serve as a technical resource for complex analytical challenges. This individual will also work closely with Quality, Manufacturing, Development, Project Management, and clients to support project timelines and successful product development and release.
Key Responsibilities
Laboratory & Technical Leadership
- Provide day-to-day technical leadership and oversight of QC analytical laboratory activities.
- Lead, mentor, and develop QC chemists and analysts, providing technical guidance, coaching, and performance feedback.
- Plan and prioritize laboratory workload to ensure analytical testing and project activities are completed accurately and within established timelines.
- Serve as a technical resource for complex analytical issues, investigations, troubleshooting, and laboratory problem-solving.
- Maintain a hands-on role in analytical testing and laboratory activities as needed.
Analytical Testing & Method Development
- Perform and oversee analytical testing of raw materials, in-process samples, stability samples, and finished pharmaceutical products.
- Execute and provide technical oversight for method development, method transfer, validation, and analytical troubleshooting activities.
- Review analytical methods, protocols, reports, and laboratory documentation for technical accuracy and compliance.
- Support stability programs, equipment qualification/calibration activities, and routine laboratory maintenance.
- Evaluate analytical results and assist with investigations involving atypical results, deviations, OOS/OOT results, and other laboratory events.
- Provide technical support for assay, impurities, dissolution, content uniformity, and other pharmaceutical analytical testing.
Instrumentation
Maintain strong hands-on knowledge and provide technical oversight of analytical instrumentation, including:
- HPLC/UHPLC
- Dissolution systems
- ICP-MS
- UV/Vis Spectrophotometers
- Gas Chromatography (GC)
- Karl Fischer
- Malvern particle size analyzers
- Other laboratory instrumentation and analytical technologies
Quality & Compliance
- Ensure laboratory activities are performed in accordance with cGMP, FDA, USP, ICH, and applicable regulatory requirements.
- Perform and oversee second-person review of analytical data to ensure accuracy, completeness, and data integrity.
- Review laboratory records, analytical data, protocols, reports, and other controlled documentation.
- Support regulatory inspections, client audits, internal audits, and quality initiatives.
- Promote a culture of data integrity, right-first-time execution, and continuous improvement.
- Identify opportunities to improve laboratory processes, workflows, methods, and overall operational efficiency.
Cross-Functional & Client Support
- Collaborate with Quality Assurance, Manufacturing, Analytical Development, Project Management, and other cross-functional teams.
- Partner with project teams to prioritize laboratory activities and meet client and project timelines.
- Interact directly with clients as a technical representative when appropriate, providing analytical updates and addressing technical questions.
- Participate in client meetings, technical discussions, and project planning activities.
- Contribute to continuous improvement initiatives with a focus on prevention, Quality by Design (QbD), and operational excellence.
Systems & Documentation
- Utilize electronic laboratory systems, including LIMS and electronic laboratory notebooks.
- Ensure laboratory documentation is complete, accurate, and maintained in accordance with established procedures.
- Support development and implementation of laboratory SOPs, procedures, and best practices.
- Maintain appropriate laboratory records and ensure timely completion of required documentation.
Qualifications
- Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline; Master's degree preferred.
- 7+ years of pharmaceutical analytical laboratory experience, with progressively increasing responsibility; 10+ years preferred.
- Previous experience providing technical leadership, mentoring, project leadership, or direct supervision within a QC or pharmaceutical laboratory environment.
- Strong hands-on experience in a cGMP pharmaceutical laboratory.
- Demonstrated expertise with HPLC/UHPLC, dissolution testing, and other analytical instrumentation.
- Proven experience with analytical method development, method validation, method transfer, and analytical troubleshooting.
- Strong understanding of FDA, USP, ICH, 21 CFR, and applicable cGMP requirements.
- Experience with laboratory investigations, including OOS/OOT results, deviations, and root-cause analysis.
- Experience performing or overseeing second-person analytical data review.
- Experience supporting regulatory inspections and/or client audits strongly preferred.
- Strong written and verbal communication skills with the ability to work effectively across technical and cross-functional teams.
- Demonstrated ability to prioritize multiple projects and laboratory activities in a fast-paced CDMO environment.
- Strong leadership, mentoring, problem-solving, and organizational skills.
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