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
For the position we offer at least an annual gross salary of EUR 65.000,-. The actual remuneration package will be based on your professional experience, qualification and skills. Increased pay is possible.
Please send your cover letter and resume to email@example.com
We look forward to receiving your application!