POSITION FILLED
Lytix Biopharma is hiring a CMC manager
POSITION FILLED
For one of the most exciting biotechnology companies in Norway, we are looking for an experienced CMC professional.
Lytix Biopharma is a Norwegian biotech company developing novel oncolytic molecules to fight cancer. Lytix is currently running a Phase II study with its lead compound, LTX-315, for treatment of advanced melanoma in US and EU. Another Phase II study in US is conducted by Lytix` license partner Verrica for treatment of basal cell carcinoma (BCC). LTX-401, a second-generation compound, is in development for entry into human clinical studies for patients with deep-seated lesions.
To follow-up the CMC work (chemistry, manufacture, control) of these and other drug candidates in the research phase, Lytix is seeking an experienced CMC professional to expand and strengthen the team. You will have broad variability in the tasks and extended responsibilities. You will be offered the opportunity to work with a highly dedicated and skilled team which is willing to walk the extra mile.
Main Responsibilities include, but are not limited to:
Formulation and development activities, manufacture, quality control and release of Drug Substance and Drug Product for use in pre-clinical and clinical studies
Issuing development reports, CMC documentation etc.
Selection, qualification and follow-ups of CRO's, CDMO's and Consultants as appropriate
Preparation of regulatory documentation for clinical trial applications
Development and manufacture that are conducted in accordance with regulatory requirements (EMA/FDA, GMP, ISO, lCH etc) and clinical trial applications (IMPD, IND)
Who are you?
Msc or PhD in Pharmaceutical Technology, Chemistry, Analytics, Biotechnology or similar
More than 5 years’ experience from CMC in pharmaceutical or biotech industry
Good understanding of quality and regulatory requirements
Experience in managing subcontractors (CDMOs, CROs, consultants) is preferred
Team player
Fluent in English, both written and oral
Highly motivated and results-oriented
Organized and ability to work independently
The ideal candidate will be a highly motivated individual with experience from, and interest in, working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Additional info:
The position will be based at Lytix Biopharma´s offices in Nydalen, Oslo, Norway.
This position reports to Chief Technical Officer, Gry Stensrud.
Contact information:
The recruitment process is carried out in collaboration with the consulting company Borka Consulting AS.
If you have any questions regarding Lytix Biopharma or the position, feel free to contact our recruitment advisor in Borka Consulting; Cecilie Borka at +47 928 55 352 or email to cecilie@borka.no.
Søknad: STILLINGEN ER BESATT
