Director of Quality @ Eric currently oversees operational Quality teams in Incoming QA, Supplier Quality, Plant QA, and Quality Systems. He successfully completed his role as Quality lead for the Amgen Dun Laoghaire expansion program which added facilities, utilities, and equipment for a new syringe filler isolator, a new packaging hall, and a new cold chain warehouse.
Director of Quality @ Eric currently oversees operational Quality teams in Incoming QA, Supplier Quality, Plant QA, and Quality Systems. He successfully completed his role as Quality lead for the Amgen Dun Laoghaire expansion program which added facilities, utilities, and equipment for a new syringe filler isolator, a new packaging hall, and a new cold chain warehouse. From May 2011 to Present (4 years 8 months) Director of Supplier Quality @ Eric led Amgen's globally based corporate SQM team to ensure that suppliers reliably provided the quality materials necessary for Amgen to manufacture vital medicines for patients worldwide. In this role, Eric drove the transformation and maturation of the core systems and processes that support supplier management at Amgen.
Also during this time, with mentoring and support from Martin VanTrieste, Eric co-founded and co-led the industry wide Supplier Quality discussion group. This group became highly valued by industry and regulators for its relevent cross-company benchmarking and focus on supply chain security. The member companies of this group became the nucleus of Rx-360. Eric served as co-chair and moderator for numerous conferences and presented on the subjects of Supplier Quality and Supply Chain Security on behalf of Amgen and Rx-360 at over 20 conferences and events held by DCAT, IPEC, PDA, USP, and other industry groups to audiences from 50 to 700 people in Asia, Europe, and North America. From May 2005 to May 2011 (6 years 1 month) Project Manager / Sr. Project Manager @ Over the span of nearly 7 years, Eric worked as a project and program manager within Operations with primary focus on Quality initiatives.
1 year as leader of Quality Project Management Office.
3 years in staff position for VP of Worldwide Quality. Duties included development and ongoing management of web communications, monthly newsletter, coordination and management of all-staff meetings, presentation development, and special projects. Served as facilitator and meeting manager for senior management leadership team meetings and offsite work sessions.
1 year as project manager for Product Disposition Alignment Initiative. Led design, testing and implementation of commercial product disposition requirements at sites in California, Colorado, Puerto Rico, and the Netherlands.
2 years as project manager for GMP document project. Implemented approach for authoring object based GMP manufacturing procedures. Project scope was multi-plant and multi-site. Personell management included internal staff and external consultants. Established post-project sustainable business process and ownership. From October 1998 to May 2005 (6 years 8 months) Manufacturing Associate / Supervisor @ Contributed to start-up and operations for 3 GMP facilities. Duties included hands on manufacturing operations, personnel management, production and disposition oversight, production scheduling, and generation of GMP procedures and production records. GMP production experience included 20+ clinical products and 400+ production batches. Direct experience with microbial fermentation, protein purification, and formulation unit operations. From October 1992 to October 1998 (6 years 1 month)
Bachelor of Science (B.Sc.), Biology @ California Lutheran University From 1989 to 1992 Eric Berg is skilled in: GMP, Biopharmaceuticals, Biotechnology, CAPA, FDA, Pharmaceutical Industry, Aseptic Processing, Validation, Change Control, Quality System, 21 CFR Part 11, LIMS, Manufacturing, Quality Management, Cleaning Validation