Elmar PhD's Email

Director Quality Unit @ Site Quality Head providing leadership and guidance for the entire Quality organization (QA, QC) Responsible for the oversight to manufacturing, testing and release of biological APIs and Drug Products Member of the Site Management Team Design of overall Quality objectives and long-range goals. Continuous review of Quality Metrics and financial KPIs to ensure meeting strategic and operational objectives Leadership and staff selection, talent and performance management Organization and conduct of authority inspections (main escort), established track record of successful regulatory inspections Quality support for technology transfers Third party management Internal and external auditing Maintenance of permanent inspection readiness on site Primary site contact for FDA Multi-year experience as Qualified Person, Member of the European QP Association From October 2012 to Present (3 years 1 month) UlmQuality Assurance / Qualified Person @ Associate Director Quality Assurance Qualified Person for Biotechnological Products in clinical development (NBEs and Biosimilars) Fields of experience: API manufacture, aseptic filling, packaging and testing of Biopharmaceuticals Validation of biopharmaceutical processes and analytical methods Maintenance and enhancement of quality systems related to development of Biopharmaceuticals in clinical development Preparation and negotiation of Quality Agreements with internal and external partners Preparation and support of inspections by clients and authorities (including several FDA cGMP and Pre-Approval inspections) Certified GMP lead auditor, conduct of global GMP audits as part of BI's supplier qualification program Member of the European QP Association From August 2004 to September 2012 (8 years 2 months) Biberach an der Riss / GermanyHead of Quality Control / Qualified Person @ Lab Manager Quality Control - Testing of Bulk Drug Products and Finished Goods (solid dosage forms, liquids and ointments) Head of Quality Control with overall QC responsibility on site (analytical including microbiological testing of starting and packaging materials, APIs and Drug Products) Management of a team of 80 department personnel Head of liquid dosage form manufacture Qualified Person and Quality Assurance Manager Fields of special experience: Validation of pharmaceutical manufacturing processes for solid, liquid and semi-solid dosage forms (including packaging) and related analytical testing methods Profound understanding of cGMP requirements From October 1990 to July 2004 (13 years 10 months) Illertissen

Doctorate, Pharmaceutical analytical chemistry @ Friedrich-Alexander University Erlangen-NuernbergState examination, Pharmaceutics @ Friedrich-Alexander-University Erlangen-NuernbergPhD, Post Doc appointment @ Friedrich-Alexander-University Erlangen-Nuernberg Elmar PhD is skilled in: Validation, GMP, Biopharmaceuticals, Pharmaceutical Industry, Quality Assurance, Clinical Development, Quality Control, Regulatory Affairs, Manufacturing, GxP, Technology Transfer, Vaccines, Microbiology, CAPA, GLP, Sop, Change Control, Quality System, SOP