The CMC Project Manager will play a pivotal role within the CMC team, by working closely together with the CTO and shoulder-to-shoulder with all CMC unit leads: biologics, radiopharmaceuticals, supply chain and quality control.
Our lead asset Betalutin® consists of the murine antibody lilotomab, which targets the CD37 antigen on the surface of NHL cells, conjugated to the beta-emitting isotope lutetium-177 (177Lu) via the chemical linker p-SCN-Bn-DOTA. Prior to administration of Betalutin®, the patient receives an infusion of the naked antibody lilotomab. The production of Betalutin® is complex and is performed at multiple Contract Manufacturing Organisations (CMOs). Ensuring a seamless and effective collaboration with the different CMO partners will be the CMC Project Manager’s primary focus.
Key responsibilities include:
Be a member of the CMC leadership team
- Partner with the Chief Technology Officer (CTO), the CMC unit heads and other project directors at Nordic Nanovector on the coordination of development and manufacturing activities.
- Ensuring a tight alignment amongst CMC unit leads on deliverables and deadlines related to the BLA readiness projects
- Providing support to the CMC planning activities (budgeting, controlling, priority setting)
- Contributing to defining and executing the CMC strategy for Nordic Nanovector’s portfolio
Project manage CMC activities cross-unit and cross-functionally
- Align with CTO on cross-functional projects requiring dedicated support, and define objectives and time-plan with CTO and unit leads
- Execute against assigned CMC projects, within defined scope and budget
- Ensure timely, transparent and thorough communication with all functions, as well as externally with Nordic Nanovector’s CMOs and other trusted partners.
- Support drafting and execution of updated/new agreements with CMO’s and CRO’s targeted to the execution of Nordic Nanovector’s CMC strategy
What we are looking for
- PhD or Master’s Degree in Chemistry, Pharmacy, Biology, Biotech Engineering; or the like
- Proven track record of developing and implementing CMC work plans to support phase appropriate activities, including management of timelines and budget
- Ability to solve complex problems and to propose innovative solutions
- Demonstrated understanding of CMC development and manufacturing in the field of biologics and radiopharmaceuticals
- Strong leadership skills, including resilience, tolerance for ambiguity and a strategic mindset
- High proficiency in English with clear communication and presentation skills
- Confident personality, ability to work in team, good interpersonal and negotiating skills
LOCATION AND REPORTING LINE
The position reports to the Chief Technology Officer and is located in Oslo, Norway. The flexibility to travel is required. Nordic Nanovector offers a challenging and exciting role in one of Norway’s most innovative biotech companies.
The position will be a temporary employment for 24 months and further employment thereafter would need to be discussed.
Level of compensation will reflect experience and qualifications.
We take pride in our dedication to the company’s mission to extend and improve the lives of patients with haematological cancers, and it is important that all members of our team are connected to this purpose.
How to apply:
Please send your CV together with a one-page motivational letter on why you are suited for the position to:
Chief Human Resources Officer
Nordic Nanovector ASA
Phone: +47 926 00 465
Nordic Nanovector’s mission is to extend and improve the lives of patients with haematological cancers by developing and commercialising next-generation radio-immunotherapies.
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
Nordic Nanovector was established in Oslo in 2009 and is since March 2015 listed on the Oslo Stock Exchange.