Provide guidance within the Quality Control Raw Materials function and across JHL Biotech, Inc. as needed in preparation for cGMP/PAI and commercial manufacturing.
This function is responsible for:
1. Supplier-Material Qualification Program
o Qualification and testing of raw materials in compliance with international regulatory standards.
o TSE risk analysis
2. Risk management (Specifications, Quality Systems, general application)
3. Oversight of RM staff and management Contract test Laboratories (CTL’s)
4. Lean Management and continuous improvement
5. Contributing to investigations pertaining to raw materials and evaluating the impact of excursions on product and ongoing operations
6. Active participation in the development and implementation of Laboratory Information Management System (LIMS) supporting analytical, stability, and raw materials
Essential functions include but are not limited to the following:
1. Establishment of Raw Material Specifications
2. Day to day oversight of Raw Materials testing program, including scheduling and coordination of sampling, laboratory testing and data review as well as raw material and in-process solution stability.
3. Demonstrated knowledge of US FDA, HC and EMEA Raw Material sampling and qualification.
4. Identification, transfer, qualification, optimization, validation and routine use of methods for the analysis of raw materials and in-process solutions
o Implement and maintain Material Qualification program for critical and mutli-compendia materials
o Implement non-compendia method validation /qualification
o Raw material stability testing
o Assesses new and evolving regulatory standards and technology to determine how to implement within Cell Genesys and ensure appropriate implementation.
o Assists in selection and validation of new equipment. Ability to recognize, trouble-shoot, and resolve problems with equipment or individual assays.
5. Support Supplier Qualification program as a member of the Supplier Review Board
6. Proficient in investigation and analysis of raw materials analysis and evaluation of impact of excursions on product and ongoing operations.
7. Designs and implements methods to increase efficiency and productivity of analytical testing functions.
8. Ensures test methods are qualified/validated to support release of materials for production of products for commercial or clinical use. Optimizes test procedures to improve efficiency whenever possible.
Job Qualifications (Education, Certifications, Experience)
B.S. Chemistry plus a minimum of 10 years plus experience in pharmaceutical organizations, M.S. and 7 years plus or equivalent preferably in a quality role. Demonstrated capability and ability to effectively plan for short term and long range needs.
1. Thorough knowledge of standard analytical methods including but not limited to – wet chemistry, HPLC, IR, MS, GC.
2. Strong computer system and database skills
3. Ability to investigate and solve problems
4. Ability to effectively commnicate with personnel from multiple disciplines and experience bases across the operations organization.