Stellenausschreibung IR-0007 oncoAdmin 2020-10-19T17:31:50+02:00
Senior Manager – CMC Biologics (m/f/d)
OncoOne is a biotech startup dedicated to developing innovative therapeutics to treat patients with solid tumors. OncoOne is an equal opportunity employer that maintains a diverse and inclusive work culture.
We are seeking a highly motivated and creative CMC Biologics Senior Manager to lead manufacturing, analytics and quality control efforts and to assist in the development of antibody-based cancer therapeutics at our offices and laboratories at Karl Farkas-Gasse 22, Vienna.
Duties & Responsibilities
Transfer manufacturing of novel therapeutics from research grade to GLP/GMP, working closely with a team of scientists and research associates as well as external vendors and CROs/CMOs
Technical oversight of cell line development, cell banking, upstream process development, protein purification, formulation and bioanalytical and quality control
Maintain effective working relationship with CRO/CMO partners
Development and establishment of release assays for drug substance and drug product
In-depth characterization of mammalian proteins including antibodies, antibody fragments, and novel protein constructs
Assay development to support preclinical studies and clinical trials, oversee assay transfer, validation and sample analysis at CRO
Contribute to filing documents by writing and approving technical reports and CMC sections
Write grant applications, patent applications and scientific publications
Present data reports and results to management, Scientific Advisory Board, investors, and other stakeholders
PhD in life science with strong background in biochemistry, biotechnology and protein engineering
Five or more years of professional experience in biotech or pharmaceutical industry mandatory
Proven experience in dealing with regulatory requirements and in preparation and coordination of regulatory strategy plans
Strong experience using various protein expression platforms (mammalian and bacterial cells) and protein purification systems (affinity chromatography, HIC, IEX, SEC, etc.)
Highly skilled in protein and antibody analytics, including state of the art technologies (e.g. HPLC, LC-MS/MS, DLS, SPR, CD)
Proactive management skills and ability to work with research organization, preclinical team, project management and CROs/CMOs
Well-organized and self-reliant
Excellent team spirit, communication, and presentation skills
Fluency in English
Relevant computer skills
We offer a competitive salary based on professional and personal skills as well as professional experience. The base pay for this position, according to the Austrian collective agreement, is € 47.995,- gross per year (full-time).
Please send your cover letter and resume to email@example.com
We look forward to receiving your application!
Innovation for Patients
OncoOne Research & Development GmbH
Höhenstraße 19/2 | 3400 Klosterneuburg | Austria | firstname.lastname@example.org
Quelle : OncoOne Research & Development GmbH