Head, GMP Quality Management
CBT Pharmaceuticals, Inc. is an innovative biopharmaceutical company committed to becoming a global leader in the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to tame cancer. The company’s existing pipeline of five development-stage assets include three novel humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and two targeted therapies against uncontrolled growth signaling pathways.
The company was founded in 2016 with locations in Pleasanton, California, USA, Hangzhou, P.R. China and Australia. For additional information, visit www.cbtpharma.com.
Site Head of GMP Quality Management of CBT Hangzhou Manufacturing
Location: Hangzhou, P.R.C.
CBT plans to build a biologic manufacturing facility fit-for-purpose to support current and future programs. The Site Head of GMP Quality Management will be responsible for establishing the quality systems on site to support the manufacture and release of CBT’s clinical and future commercial products. The Site Head of GMP Quality Management will be responsible for overseeing all GMP aspects of product quality and supply chain for all programs at the CBT Hangzhou site, reporting to the General Manager of the CBT China Site with a dotted line reporting to the Global Head of Quality CBT Pharma. The Site Head of GMP Manufacturing Quality Management will interpret external regulatory standards and expectations into appropriate quality standards and provide guidance to project teams or functions to ensure overall compliance. S/he will also closely work with our global external partners to ensure that the CBT-manufactured product quality meets global standards.
This role will spend a majority of their time in Hangzhou, P.R. China.
Specific responsibilities include, but not limited to:
- Establish a QMS at CBT’s planned GMP biologic manufactured site at Hangzhou, such as lead efforts to establish, document, implement and maintain relevant Quality Control Standards and Operation Protocols for the company’s drug substance and drug product biomanufacturing facilities.
- Oversee Quality Control functions to develop, transfer and validate analytical testing methods, performing QC testing including Microbiology testing for sterility assurance, environmental monitoring programs, raw material controls, reference standard/critical reagents, and quality control testing for in-process, lot release and stability per established specifications or acceptance criteria for Biologics manufactured by CBT.
- Oversee deviation and Out of Specification investigations and closure,CAPA management and change control.
- Establish a document control function for documentation and data management.
- Coordinate external Regulatory Authority (China, US & EU Regulations) GMP inspections and support implementation of agreed global standards for manufacture.
- Define and implement phase appropriate Quality by Design (QbD) and Quality Management strategies for GMP manufacture of CBTs products.
- Work with external consultants and vendors on assignments that are important to advance company’s and its partner’s manufacturing capabilities.
- Develop metrics and initiatives to improve quality and productivity through combination of talent, processes and technology.
- As a part of core leadership team, participate in formulating and shaping strategies that affect the growth, operations and plans of the CMC functions at CBT.
- Prior QMS leadership experience at a Biologic GMP manufacturing site is required.
- Advanced degree in a scientific discipline or qualified professional in quality and compliance.
- Effective leader with minimum of 15 years of industrial experience associated with GMP Quality Management for development and manufacturing of biopharmaceuticals and small molecule drugs. Experience with GMP compliance and monoclonal antibody biologics is required; experience with small molecule drugs is a plus.
- Demonstrated skills with the development, management and evaluation of strategies, standards, risk assessment and management in accordance with the overall strategic objectives and applicable regulatory requirements. Specifically, owning Quality outcomes, as defined by Core Measures and Risk Management.
- Experience with overseeing quality management activities with CMOs/CDMOs.
- Knowledge of the quality regulations and guidelines applicable to the design, build and commissioning of facilities for biologic GMP manufacturing including manufacturing of Drug Substances and Drug Products.
- Motivated to work in a fast-paced, high accountability, small company environment. A “can do” and collegial professional who leads through influence and interpersonal skills.
- Good interpersonal communication skills and effective people manager, excellent oral and written English; Speaks Mandarin and is able to read Chinese.
CBT Pharmaceuticals offers medical, dental, and vision insurance, PTO days, and 401K plan that includes a company match.