QA Specialist for Symphogen
Symphogen A/S is facing an exciting and challenging period of growth, which offers the right job applicants great opportunities to influence job content and develop additional skills. The CMC function at Symphogen is highly dynamic and manages all activities within CMC development, CMC project management, clinical supply and the corporate quality system. We support Symphogen projects in all phases of development from early discovery to process validation and beyond.
To help us reach our mission we are looking for experienced and motivated candidates to the following position:
QA Specialist for Symphogen
Symphogen is currently experiencing an increase in activities within both the early and late stage projects. Furthermore, Symphogen is planning to start phase III clinical trials, and to apply for a license to manufacturing and import (§39).
Symphogen therefore plan to strengthen the QA organization with a QA/QP specialist.
As QA/QP you will be involved in every step of the manufacturing process from generation of cell banks, upstream and downstream processes, final formulation, filling, analysis and release of the final drug product.
The QA Specialist will be the main responsible person from the quality group for our lead project covering process- and analytical validation, PPQ, clinical supply, and eventually marketing application.
Tasks and Responsibilities
The responsibilities include, but are not necessarily limited to:
- Support the evelopment of Symphogen QMS to ensure compliance with EU and FDA GMP and GCP
- Supervision of GMP manufacturing of clinical trial material including review and approval of qualification and validation protocols and reports, master batch records, SOPs, and other documents
- Execution of internal audits in both production, laboratory and IT areas
- Release of drug products for clinical trials in the EU and US, initially for clinical trials, and eventually commercial use
- Audits of suppliers, including supplier of raw materials and CMOs
- Compliance with all relevant GXP guidelines including GLP, GMP, and GCP
- Supervision of internal and external process development activities to ensure compliance with ICH guidelines Q8 and Q9
- Participation in development of the company's lead candidate to prepare for process validation and eventually marketing application
The ideal candidate:
- has a university education in life science (MSc or similar) fulfilling the requirements for Qualified person
- has a minimum of 5, preferably 10 years relevant experience in the biopharmaceuticals industry
- has experience in collaboration with R&D staff and transfer of processes and methods from R&D into GMP
- has extensive and updated GMP and GCP knowledge, including familiarity with the current FDA, EMA, and ICH guidelines
- has experience with GMP manufacturing of biologic drug substances and drug products for clinical trials
- is a trained auditor of GMP and GCP, preferably a lead auditor
- is a strong communicator, who is able to be flexible and cooperative
- has experience with quality oversight of clinical studies
Working in Symphogen
When being a part of Symphogen you will always have a challenging job in a creative, goaloriented, value-based biotech environment with a meaningful mission. You will be a part of a highly engaged organization with a passion of being the worldwide leading recombinant polyclonal antibody company.
You will have good development opportunities, in an organization that is inspiring and growing, with focus on diversity, teamwork, commitment and you as a person.
For further information
For more information please contact CMO, Mads Laustsen at +4529488401 or HR Coordinator, Pia Holm Olesen at +45 4526 5050. Please also see www.symphogen.com for more information about our company.
If you are interested in the position, please mark your application and CV "QA Specialist" and mail it to: firstname.lastname@example.org no later than September 20, 2017. Potential candidates will be invited for interview as they apply and we reserve the right to terminate before the posting expires.
We look forward to hearing from you!
Antibody therapeutics is currently the fastest growing business in the pharmaceutical industry. Following the historical success of monoclonal antibodies, Symphogen is striving to develop and commercialize superior antibody mixtures based on the diversity of the natural human immune system by use of Symphogen's proprietary technology suite. Symphogen A/S has built an innovative oncology pipeline consisting of mAbs and mAb mixtures, and performs activities from early discovery to mid-stage clinical development, which translates into new and challenging opportunities for our organization and employees. Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 110+ people.
Developing symphonies of antibodies require an orchestrated mix of scientific disciplines. Symphogen is fortunate to employ a dynamic team of hardworking, passionate scientists and professionals committed to advancing the frontier of antibody therapeutics.
We offer a professionally challenging working environment to candidates with the right skill set within antibody immunotherapy, molecular biology, antibody discovery, and protein expression. Preferred applicants for scientific positions should hold a minimum of three years post-doctoral research experience within oncology.
Should you possess such skills, we invite you to join a vibrant discovery and development culture that strives for excellence and innovation for pioneering achievements in the world of antibody mixtures.
We encourage qualified candidates to send their CV by e-mail to email@example.com.