Senior Manager, Quality Control

Description

Senior Manager, Quality Control at Boehringer Ingelheim Fremont, Inc. in Fremont, CA (Telecommuting permitted : work may be performed within normal commuting distance from this office 20% of the time)

Job Duties : Directly lead a team of 7 people responsible for all In Process Control (IPC) testing within the site. Serve as the site's Quality Control's single point of contact into manufacturing to ensure collaboration and adherence to turn-around-times and compliance.

Responsible for implementation of corporate standards within the newly created area. Responsible for development, validation, and implementation of analytical methods for new biopharmaceutical products.

Drive innovation and digitalization (especially establishment of Process Analytical Technology (PAT)) within Quality Control according to the company's vision.

Initiate and sponsor continuous improvement projects. Serve as equipment owner and process owner for all equipment within the IPC lab.

Telecommuting permitted : work may be performed within normal commuting distance from the Boehringer Ingelheim Fremont, Inc.

office in Fremont, CA 20% of the time.

Work Schedule : 40 hours per week (8 : 00am to 5 : 00pm)

Job Requirements : Master's degree (U.S. or foreign equivalent) in Chemistry, Biology, Biochemistry, or a related field and eight (8) years of experience in the job offered or in a related role OR Bachelor's degree (U.

S. or foreign equivalent) in Chemistry, Biology, Biochemistry, or a related field and ten (10) years of experience in the job offered or in a related role.

Must have eight (8) years of experience applying knowledge of lab processes, including sample processes, reagent inventory management, data integrity, good documentation practice, or similar process.

• Must have five (5) years of experience with : analytical technologies and equipment, including High Performance Liquid Chromatography (HPLC), Total Organic Carbon (TOC), and Conductivity;
• working with current Good Manufacturing Practices (cGMP); method validation, verification, and transfer according to ICH (International Council for Harmonization) and FDA (Food and Drug Administration) guidelines;

and, applying knowledge of corporate business processes and Standard Operating Procedures, including training, non-conformance management, change control, or similar process / procedure.

• Must have three (3) years of experience with : handling Out-of-Specification results (OOS) and lab deviations; applying knowledge of Biotechnology products and purification processes;
• and leading a team to meet tight deadlines. Must have two (2) years of experience with : interacting with Health Authorities, including FDA or EMA (European Medicines Agency), during inspections;
• working with Regulatory Filing documentation, including BLA (Biologics License Application) or NDA (New Drug Application);

and Project Management. *10% domestic and international travel required.

Salary : $178,379 - $193,000 per year

PDN-9d24c3a2-56a2-4e3d-9022-995b40ca0b0c