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 retains global marketing rights to Betalutin® and intends to actively participate in the commercialisation of Betalutin® in the US and other major markets.
Further information can be found at www.nordicnanovector.com.
Senior Manager Analytical Method Development
On behalf of Nordic Nanovector ASA we are looking for an experienced Senior Manager Analytical Method Development who will be responsible for analytical method development and validation within Nordic Nanovector, and coordination and follow-up of related activities with contract manufacturing organizations. The position is an opportunity to join an innovative company in the pharmaceutical industry which works towards new and promising cancer treatments. The Senior Manager Analytical Method Development will be part of a diverse, dedicated and highly experienced CMC team.
* Development and implementation of analytical methods of starting materials, intermediates and drug substances / drug products in the field of biologics and/or radiopharmaceuticals
* Lead the validation of analytical methods and ensure that they are initiated and performed in accordance with project timelines
* Prepare regulatory documents
* Responsible to document, review, write and approve reports and protocols related to analytical methods, method validations, batch documentation, comparability and stability studies
* Responsible for topics related to analytical methods, stability and quality control during process validation and characterization activities
* Responsible for the technical documentation, justification and evaluation of specifications, analytical procedures and stability studies
* Participate in development and implementation of internal strategies, practices and procedures related to analytical method development and quality control
* Work closely with all functions and provide technical expertise on topics related to analytical methods
* Writing of SOPs related to analytical methods
* Handle deviations, changes, risk assessments, CAPAs etc. related to analytical methods and procedures
* Responsible for the budget related to analytical method development
* Stay current on trends and technologies in the field of analytical quality control
* Communicate all matters related to the responsibilities of this position with line and project managers, regarding estimated timelines and possible interferences with successful and timely completion of internal projects
What we are looking for
* Master or PhD in a relevant subject related to analytical chemistry, pharmacy and/or quality control
* Minimum 5 years of experience with analytical method development, quality control and method validation activities
* Extensive technical experience in analytical method development, quality assurance, quality control and manufacturing under GMP environment, preferably from the pharmaceutical industry supporting clinical or licensed products
* Experience with various quality processes (e.g. investigations/deviations, CAPAs, change controls etc.)
* Excellent working knowledge of GMP regulations and relevant guidelines for quality control and stability programs
* Excellent analytical and problem-solving skills, with high standards for systems and accuracy
* Excellent communication skills, with a high proficiency in English, written and spoken
Reporting line, location and compensation.
The position reports to the Director Radiopharmaceutical Production and is based at the company's headquarters in Oslo, Norway. Nordic Nanovector offers a challenging and exciting role in one of Norway's most innovative pharmaceutical companies. Level of compensation will reflect experience and qualifications.
For further information about this position please contact our recruitment partner at Kelly Science: Branch Manager Thomas Lund, +47 815 00 044 or Consultant Jacquelyn Diamond +47 969 07 226.
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