QA Associate Director (m/f) QA Associate Director Prima BioMed seeks a QA Associate Director to support the manufacture of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) to ensure that Prima’s product are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. The position involves quality oversight of CMOs and liaison of quality related issues with Chemistry, Manufacturing and Control (CMC) Team and functional management. The scope of the position encompasses oversight of all aspects of drug manufacture through clinical development and into commercial phase. Job Location: Leipzig, Germany Responsibilities: The successful incumbent will be the QA Representative on CMC Teams responsible for drug manufacture. The position will require regular interaction with QA management at both the CMO and prima Biomed on matters concerning the product quality and CMO GMP compliance. This may include, but is not limited to: Establishing Quality Agreements with CMO’s Master Batch Record (MBR) review and approval as compliant with good manufacturing practice regulations, regulatory filings and quality agreements. Review of executed batch records, Certificates of Analysis and other documents to enable drug substance and final drug product release certifying batches as GMP compliant. Reviewing and communicating deviations at CMOs to PBM CMC Teams and functional management. Obtaining and communicating PBM deviation investigation requirements to CMOs and working with CMOs to investigate deviations until resolved. Review equipment qualification protocols and reports. Communication of changes between PBM and CMOs. Monitoring documentation and implementation of changes until completed successfully. Performance of contractor quality system reviews and gap analysis as part of CMO selection and maintenance. Review and approval of contractor documentation necessary for the manufacture and testing, as well as approval of technology transfer protocols, discrepancies, deviations and reports. Conduct GMP compliance audits of contractors and suppliers. Provide support in the preparation for and during governmental regulatory agency inspections of PBM contractors. Job Requirements: Bachelor’s degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with experience in QA oversight of pharmaceutical development and manufacturing. Knowledge of cell culture and purification processing and associated batch record review of biologic manufacturing is helpful. Practical knowledge of cGMPs and an ability to apply sound judgment and decision making skills (risk based and appropriate for the phase of clinical development) in order to evaluate product release. Working knowledge of US and EU cGMP regulations and guidelines Experience in auditing suppliers and CMO’s Strong planning and time management skills and ability to prioritize own work. Leadership experience is strongly preferred Excellent communication skills and flexibility will be essential for working in a dynamic start-up company. Due to our company’s international orientation we require excellent English as well as good German skills Ability to work with Microsoft office suite (Word, Excel, PowerPoint minimally needed, Access a plus). We offer a competitive salary in an international environment as well as excellent opportunities for professional and personal development. If your background and personal experience fits this profile, please send your complete application via e-mail to [email protected] Our Webpage: www.primabiomed.com.au
(im Bereich Forschung & Entwicklung, Qualitätssicherung/-management) mehr...
30.03.2013Prima Biomed GmbHLeipzig50044 Scientist (m/f) immunological and biochemical methods and cell culture Prima BioMed GmbH based in Leipzig is an affiliate of Prima BioMed Ltd., a globally active Australian biotechnology company engaged in cancer research with the focus to develop new therapies to treat unmet medical needs based on the emerging technology of immunotherapy. Our lead program CVac™ is in late stage clinical development. Scientist Location: Leipzig Responsibilities: As a Scientist in optimisation manufacturing at Prima BioMed GmbH you will be responsible for the optimisation of the manufacturing process as well as for validation of the analytical methods according to ICH Q2(R1) guidelines. You design project plans, guide technical staff and organize laboratory tasks. Furthermore you will be responsible for the documentation, regular reporting and presentation of your projects as well as writing final project reports. Reporting: Job Description Manage a team of 3-4 people (technicians and scientists) for the optimisation of manufacturing and validation of the analytical methods Guide and plan the different stages of manufacturing optimisation as well as ICH compliant validation of the analytical methods Design and perform GMP compliant validation of the optimised manufacturing steps Maintain laboratory infrastructure/equipment Interface with other scientists and oversee ongoing research projects Present the projects and results in global team meetings Document the progress of the projects in final reports Develop and coach your team Qualifications: Successfully completed your university studies of pharmacy, bio-technology, bio-physics, bio-chemistry or a similar education (preferably PhD; possibly MSc) Hands-on experience with immunological and biochemical methods, and cell culture is required Experience in flow cytometry and cell processing equipment would be strongly preferred Basic knowledge of ICH Q2, Q5 and Q7 is preferred Pharmaceutical or biotechnology industry experience and good manufacturing practice (GMP and / or GLP) are required Key skill sets are to have adaptive and critical problem solver, able to translate new ideas towards project plans and execution Leadership experience is strongly preferred Excellent communication skills and flexibility will be essential for working in a dynamic start-up company. Due to our company’s international orientation we require excellent English as well as good German skills Ability to work with Microsoft office suite (Word, Excel, PowerPoint minimally needed, Access a plus). We offer a competitive salary in an international environment as well as excellent opportunities for professional and personal development. If your background and personal experience fits this profile, please send your complete application to [email protected] Our Webpage: www.primabiomed.com.au
(im Bereich Forschung & Entwicklung, Klinische Forschung, Wissenschaftl. MitarbeiterIn) mehr...
30.03.2013Prima Biomed GmbHLeipzig50045 Biotechnologist (m/f) immunological and biochemical methods Prima BioMed GmbH based in Leipzig is an affiliate of Prima BioMed Ltd., a globally active Australian biotechnology company engaged in cancer research with the focus to develop new therapies to treat unmet medical needs based on the emerging technology of immunotherapy. Our lead program CVac™ is in late stage clinical development.
So, unless they are saving 500k plus, NF leaving is not financial.
Anyone leaving a company but staying on as a consultant usually equals big bucks for the consulatant - anyone disagreeing has no idea about modern business.
NF has not said why he left - everyone has just assumed it was for savings.
Employing 3 new staff negates that theory
Even if true, the CMO leaving is never a good sign no matter what spin is placed on it.
All the chickens are flying the coop.
PRR Price at posting:
8.1¢ Sentiment: None Disclosure: Not Held
(20min delay)