Senior Manager, QCApply Now
Location: Silver Spring, Maryland 20910
Employment Type: Direct Hire
Job Summary: This person will provide oversight and guidance on day-to-day activities of chemists and biochemists in the Silver Spring QC laboratory, define, propose and drive solutions for technical problems within their scope of work, and serve as an internal technical expert in physical, chemical, and biochemical testing activities.
- Provide management oversight of QC laboratory operations for all defined QC testing activities including incoming materials, in-process samples, drug substance and drug product testing. This can include oversight of product development (R&D) testing, project testing and contract laboratory testing.
- Oversee departmental training including generation, review, and approval of training plans, delivery of hands-on training as needed, monitoring for departmental training compliance, development of new training requirements as needed, and retraining needs and frequency
- Lead QC continuous improvement initiatives related to compliance/quality requirements, introduction of new products/processes, and technical operations. This includes evaluating emerging technologies as well as emerging Regulatory requirements, new instrumentation, and alternate methodologies and recommending implementation, as appropriate.
- Conduct or provide management oversight for QC-specific investigations and deviations related to testing or other QC processes. Identify adverse trends and develop and implement appropriate CAPA to address.
- Bachelor’s Degree in chemistry or related scientific field
- 10+ years of experience in a GMP pharmaceutical QC laboratory with a Bachelor's Degree and
- 7+ years of experience in a people management role in a GMP pharmaceutical QC laboratory
- Scheduling/prioritization of all assigned testing activities related to commercial manufacturing operations including incoming sampling and testing, in-process testing, finished drug substance or drug product testing, and registration and annual stability programs
- Knowledgeable of FDA cGMP requirements and USP testing requirements for pharmaceutical drug substance and product
- Excellent computer application skills required with expertise in MicroSoft Suite applications as well as chromatography application programs and LIMS systems
Rob works on the Contract team. His goal as a recruiter is to continue to establish long-term professional and personal relationships with top-performing HR professionals throughout the Greater Boston area.