QC Chemistry Manager

We are seeking a Quality Control Chemistry Manager that has a passion for leading people, and is familiar with transformational, situational, and servant leadership concepts. The Manager will support continuous personal and professional development of QC chemistry staff through meaningful goal setting, performance management, and career development plans. 
 
The Quality Control Chemistry Manager will work closely with the Director of Quality Control and will lead strategy and direction of the Quality Control Chemistry group to partner cross-functionally to identify analytical needs, solve complex problems, and deliver solutions for various routine and non-routine processes. The Manager will be influential in championing and developing our Quality Mindset through ingrained quality with skills including attention to detail, on time delivery, and efficiency into the Quality Control organization you will help build. 
 
Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The Manager will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners. The manager will thrive in a team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the manager will possess a demonstrated ability to influence positive outcome without direct reporting authority. Essential Job Functions:

• Lead, build, and foster a diverse team to establish and maintain the GMP QC Chemistry laboratory. 
• Train, support, and maintain an engaged work force competent in both theory and application of analytical, separation, and physical sciences to support a state-of-the-art aseptic drug product manufacturing facility. 
• Lead through coaching, mentoring, and maintaining at-the-bench presence in the laboratory to ensure rigorous scientific and quality work standards. 
• Lead development of a world-class QC chemistry platform by leveraging expertise to establish and launch instrumentation and laboratory workflows that adhere to procedures and regulatory requirements for the evaluation of chemical and physical properties of drug products, excipients, and process materials. This minimally includes tests for HPLC, GC, UV-VIS, TOC, particulate matter, FTIR, wet chemistry (e.g. pH, conductivity, osmometry, etc.), drug product lot release testing, stability testing, analytical method transfer, and analytical method validation. 
• Train QC chemistry team members on laboratory equipment, analytical techniques, laboratory computer systems, and workflows. 
• Prioritize and coordinate resources for QC Chemistry testing to balance client needs and production timelines with development work. 
• Serve as a site subject matter expert on analytical and physical chemistry testing, laboratory instruments, laboratory and testing compliance, current Good Laboratory Practices (cGLPs), and current Good Manufacturing Practices (cGMPs). Use knowledge of quality principles, cGLPs, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness in the QC Chemistry laboratories, and act as a key point-of-contact for regulatory agencies during inspections and audits. 
• Spearhead and leverage robust regulatory intelligence on the evolving regulatory landscape and industry trends by participating in continuous education, networking, literature, trade organizations, etc. 
• Use a positive approach to communicate safety expectations, assess safety behaviors, exercise proactive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. 
• Lead laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events. 
• Utilize various paper and automated systems (QMS, LIMS, etc.) to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring. 
• Use applied statistics to analyze test results to identify sources of error in laboratory and manufacturing processes. Use data trends to apply a systematic approach to continuous improvement. 
• As the QC chemistry laboratory owner, partner with program owners to develop PM and calibration plans to coordinate upkeep, conformity and IQ/PQ/OQ of instruments and laboratory environment. 

Special Job Requirements:

• B.S. in Biochemistry or Chemistry.
• Minimum of 5+ years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control testing in a