QA Director 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 Director for Symphogen
The position as Director of QA offers a unique possibility to take part in Symphogen's development into a mature company with its lead project in pivotal testing.
The Director (based at Symphogens headquarters in Ballerup) will be responsible for Symphogens quality function constituted of two QA Specialists in Ballerup and one GCP Manager based in US, NJ. You will be part of Symphogens CMC Directors team covering Project Management, Analysis, Process Development and Supply.
Tasks and Responsibilities
The responsibilities include all Symphogens quality regulated matters related to Good Manufacturing Practices, "Good Scientific Practices", pre-clinical and clinical supply, Good Clinical Practices, vendor and supplier qualification, process- and analytical validation, BLA filing, as well as further development of the quality function and systems, incl. establishment of an internal QP function.
Symphogen use CMO's and CRO's for GMP and GLP related supplies and clinical trial management, why qualification and quality control of Symphogens key partners is essential to the success of the company.
The responsibilities of the quality function include
- Development 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 product portfolio incl. IND and BLA filing
The ideal candidate:
- has a university degree in life science (MSc or similar) fulfilling the requirements for Qualified Person
- has a minimum of 5 years relevant line manager experience in a QA function
- has a strategic mindset
- is a strong communicator, who is able to be flexible and cooperative
- has been quality responsible for phase III and commercial biologics projects, incl. experience with IND, CTA, MAA and BLA filing
- has experience with quality oversight of clinical studies
- 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
- is a trained auditor of GMP and GCP, preferably a lead auditor
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 +45 2948 8401 or HR-Director, Lisbet Løschenkohl 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 Director" and mail it to: email@example.com no later than September 30, 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 firstname.lastname@example.org.