Upstream (and downstream) Antibody Manufacturing Process Expert (Biotechnology)

Nordic Nanovector's mission is to extend and improve the lives of patients with haematological cancers by developing and commercialising innovative antibody radionuclide conjugates (ARC).

The company's lead clinical-stage product is Betalutin, the first in a new class of antibody radionuclide conjugates (ARCs), designed to improve upon and complement current options for the treatment of non-Hodgkin lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities. Betalutin is a tumour-seeking anti-CD37 antibody conjugated to a low-intensity radionuclide (lutetium-177). It is showing promising efficiacy and tolerability in a Phase 1/2 clinical study in a difficult-to-treat NHL patient population.

The company aims to develop Betalutin for the treatment of patients witrh relapsed/refractory NHL. Nordic Nanovector is committed to building a pipeline of novel ARCs and antibody drug conjugates (ADCs) addressing multiple selected haematological malignancies based on proprietary technologies and expertise, and with technologies from partners where complementary.

Nordic Nanovector was established in Oslo in 2009 and is since March 2015 listed on the Oslo Stock Exchange. The company has offices in Norway, Switzerland and the UK:

 


Upstream (and Downstream) Antibody Manufacturing Process Expert (Biotechnology)
 
Nordic Nanovector is looking for a highly-experienced expert to lead, first and foremost, the upstream part of our antibody manufacturing processes. Ideally, the right candidate also holds significant experience in downstream processing of monoclonal antibodies.
The role is newly established and the successful candidate will join the CMC/Operations team focused on manufacturing development and supply of investigational products for early- and late-phase clinical trials. The role requires sound scientific judgement and innovation using advanced practices and procedures to achieve solutions. The process expert will evaluate and oversee the manufacturing and gain fundamental understanding of upstream cell culture processes. This position will support process validation, quality by design principles, regulatory approaches, and innovative research as well as prepare internally reviewed technical reports, and make oral presentations to the team and management when required.

KEY REPONSIBILITIES

• Responsible for the technical leadership in the design, development and validation of robust upstream manufacturing processes to effectively support antibody product development
• Provide technical leadership in process development to support pre-clinical and clinical programs at all development stages, including process development, optimization, technology transfer, and process characterization of cGMP antibody processes (cell culture and purification)
• Provide technical oversight for outsourced development and production with CMOs including budget development and preparation of CMC programs for antibodies in development
• Troubleshoot scientific and technical challenges, and contribute to their resolution
• Strong knowledge and experience with generic downstream processes
• Participate in cross-functional project teams, and lead selected projects
• Facilitate collaboration with both internal and external drug substance analytical teams, quality control and assurance, and manufacturing
• Ensure that appropriate technical strategies, timelines and budgets are in place to meet goals for pipeline development, and that production, technology transfer and regulatory outcomes meet or exceed industry standards
• She/he will author and/or review protocols, technical reports, and regulatory submissions to support clinical development and licensure

QUALIFICATIONS

• PhD degree or Master's degree with 5+ postgraduate experience in biotech/biopharma industry in the development and execution of mammalian cell culture processes
• Advanced experience in upstream bioprocessing in a laboratory setting, including knowledge of state-of-the-art equipment and industrial cell culture
• Demonstrated ability to drive for results and generate innovative solutions with minimum supervision. Applicants should be self-motivated, organized, and capable of working independently and i a collaborative environment. The succesful candidate will possess strong oral and written communication skills
• Experience in tech transfer of cell culture processes between CMOs organizations is a plus
• Strong attention to details. Ability to execute detailed experiemental plans, record procedures, analyze data, and present results
• Takes the initiative to solve scientific problems and drive their resolution
• Experience with statistical experimental design and analysis of biological processes
• Able to work in a fast paced team environment
• High proficiency in English

LOCATION AND REPORTING LINE
The position will partly be based at the company's headquarter in Oslo and partly oversee and follow up Nordic Nanovector's daily upstream manufacturing as "person-in-plant' in our CMOs facilities. The position will report to the Chief Technical and Operations Officer.
 
How to apply
Please send your CV together with a 1-page motivational letter on why you are suited for the position to:
Annemieke Otten Nesse, MSc.
Kelly Scientific Resources
Phone: +4792208761
Deadline: 2nd of March 2018