Oncopeptides is a global biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The U.S. Food and Drug Administration has recently granted PEPAXTO (melphalan flufenamide, also known as melflufen), accelerated approval in relapsed or refractory multiple myeloma. Melphalan flufenamide is the first drug originated from the Company´s proprietary PDC-platform and is evaluated in a comprehensive clinical study program, including the ongoing phase 3 OCEAN study. Melphalan flufenamide is the first anticancer peptide-drug conjugate for patients with relapsed or refractory multiple myeloma. The drug uses innovative technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound. Due to its high lipophilicity, it is distributed into the cells. Melphalan flufenamide is designed to leverage aminopeptidases, enzymes which are overexpressed in myeloma cells and cause the release of the cytotoxic agents in the cells.
Oncopeptides’ global Headquarters is based in Stockholm, Sweden and the U.S. Headquarters is situated in Boston, Mass. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. Today the company consists of 250+ co-workers in Europe and USA.
We are looking for a highly motivated CMC Project Manager who will be given opportunity to make a difference in a fast-growing biopharma company. You will be joining our CMC team, currently consisting of 4 people. The position is a full-time employment, and you will report to the CMC Director. The role is located in Stockholm.
As a Chemistry Manufacturing and Controls (CMC) Project Manager you will drive and coordinate the CMC activities in assigned projects from preclinical development through supplies for clinical phases. This also includes acting as main point of contact for Contract Development Manufacturing Organisations (CDMOs) and other external collaborators as appropriate. You will work closely together with the rest of the CMC team as well as cross-disciplinary with other functions such as R&D, Non-clinical, Regulatory Affairs, QA and Supply.
Manage CMC-related activities performed by CDMOs such as process development, scale up, analytical method development and GMP manufacture of drug substance and drug product for clinical supplies.
Collaborate with the preclinical and development project teams to guide on CMC needs.
Review/approve CMC-related documentation such as master batch records, R&D reports, reports and protocols for analytical method development and validation, stability studies, process development and investigations.
Write and review CMC parts of regulatory submissions.
Required Background, Skills, and Knowledge
An advanced degree Organic Chemistry, Pharmaceutical Chemistry or related scientific discipline. PhD or MSc is an advantage.
Understanding in process development, scale-up, GMP production and analytical method development.
Experience in formulation development is an advantage.
Experience in collaboration with external vendors and subcontractors.
Strong attention to details.
Focus on accountability and ownership.
Flexible and independent.
Customer-oriented approach and ability to effectively work in cross-functional teams.
Excellent verbal and written communication skills (English and Swedish).
Please send your CV and cover letter to SE.email@example.com and write CMC Project Manager in the subject line. We handle screening and selection continuously and therefore encourage you to apply as soon as possible, but no later than April 6. Start-date will be according to agreement. All enquiries are treated confidentially and will be handled in accordance with GDPR.