POSITION OBJECTIVE: Manage Quality Control Chemistry personnel and laboratories. Manage Incoming Quality Control personnel and areas. Oversee Quality Control (Chemistry and IQC) Metrics, Investigations, Product Development Activities as related with QC, Product Release and Continuous Improvement.
Essential Job Functions/Responsibilities
Oversee Quality Control Chemistry testing for In-Process/Bulk, Finished Product, Raw Materials, and Stability at multiple sites.
Oversee Incoming Quality Control personnel and areas at multiple sites.
Provide cGMP guidance and training to laboratory personnel regarding FDA guidelines, USP and other compendia, GXP, ICH, and EMEA.
Setup and maintain efficient laboratory systems and processes for increasing manufacturing output and additional sites/locations.
Ensure QC laboratories are in state of compliance and are inspection ready.
Ensure a safe work environment for laboratory personnel with compliance to OSHA requirements.
Provide review and approval of laboratory data, specifications, performance verifications, certificate of analysis, and no-test forms.
Conduct laboratory investigations, discrepancy investigations, environmental excursions, out of calibration reports, and CAPA in a timely manner.
Manage personnel, support departmental budget planning, develop, and maintain Quality Control testing schedules, and instrumentation vendor services.
Promote and implement staff training, motivation, and personnel development.
Complete staff assessments and performance reviews as required ensuring competencies are maintained.
Participate in personnel development programs to further enhance skills and knowledge relevant to the position.
Provide input into continuous improvement and metric development and maintenance.
Serve as SME and provide guidance for method transfers, method qualifications and ICH guidelines, validation activities for UHPLC and GC, and compendial testing.
Interacts with other function groups for projects planning and QC requirements.
Review and approve analytical procedures, specifications, and method development.
Provide a fair assessment and execute processes in hiring new staff members.
Provide support for customer and manufacturing related needs while maintaining a high level of professionalism.
Support analytical needs that occur on off-shift hours and multiple sites.
Review and approve new equipment protocols and method validation, qualification, and transfer protocols.
Interface with all regulatory agencies and customer audit representatives.
Prepare quotes and budgets for the QC department as needed.
Serve as QC SME during regulatory inspections, internal audits, and customer audits.
Required Education & Qualifications
B.S. or advanced degree in an applicable life-science with a minimum of 5 years of experience in the pharmaceutical manufacturing industry or an Associate degree in an applicable life science with a minimum of 10 years of experience in the pharmaceutical manufacturing industry.
Proven capabilities in reviewing and approving analytical procedures, specifications, analytical method transfer reports, and method development reports.
Strong leadership with experience in managing, supervising, and developing employees and teams.
Excellent verbal and written communication skills.
Ability to effectively communicate and collaborate with multiple levels within the organization to achieve measurable results.
Strong focus on quality and safety in a laboratory environment.
In depth knowledge and experience with cGMP 21 CFR 210/211/820 Quality Systems.
Working knowledge of laboratory information management systems (LIMS) and experience in leading LIMS implementation and optimization.
Advanced knowledge and implementation of data integrity principles.
Advanced organizational and time management skills.
Experience and involvement with regulatory inspections as well as internal and external audits.
Additional Salary Information: Salary commensurate with experience
Athenex is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer. Our mission is to become a global leader in bringing innovative cancer treatments to the market and improve health outcomes. To achieve this, we have assembled an experienced leadership team and have established global operations across the pharmaceutical value chain.
We have internalized our commercial infrastructure and supply chain, which we believe will enable us to capture greater shareholder value and minimize supply chain risk for our proprietary oncology drugs. Our US-based commercial sales and marketing team continues to grow as we prepare for the commercial launch of our oncology products, and we believe that our high potency oncology manufacturing facilities will create value by minimizing supply chain disruptions.
Our leadership team was carefully assembled to capture the global commercial market opportunities in novel drug development. Our executive officers are seasoned leaders with complementary skill sets across global pharmaceutical R&D, operations, supply chain and manufacturing, capital markets, and mer...gers and acquisitions. We believe we will be able to utilize this strength to create long term value for cancer patients, our employees and our shareholders. Our team is driven by the prospect of creating new paradigms in the treatment of cancer.