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CMC Manager - Studies and Operations

On behalf of Nordic Nanovector ASA we are looking for a CMC Manager who will be responsible for the oversight and management of study programs at 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 CMC Manager will be part of a diverse, dedicated and highly experienced CMC team.

Key responsibilities

• Oversight and management of compatibility, stability and comparability study programs for intermediates and drug products performed at contract manufacturing organizations in close collaboration with manufacturing and project management
• Perform technical reviews, monitoring and trending of batch records, batch release and stability data
• Ensure all cGMP data are managed and evaluated as described in relevant internal SOPs
• Update specifications of raw materials, APIs, intermediates and drug products
• Coordinate control strategy activities with contract manufacturers, as required.
• Liaise and work with analytical method development to monitor method performance over time.
• Support the CMC team in method development and validation tasks when needed.
• Work in close collaboration and support with other members of the CMC team responsible for development and manufacturing
• Author and revise CMC stability and forced degradation documents to support regulatory filings
• Handle deviations and OOS/OOT/OOE investigations in close interaction with the CMC and QA team
• Compose, review and approve SOPs and work instructions
• Complete CAPAs and change controls assigned by investigations or audit observations

What we are looking for

• Master in analytical chemistry or a relevant subject
• Minimum 3 years of experience with Quality Control, preferably from biologics production
• Excellent working knowledge of GMP regulations and relevant guidelines for quality control and stability programs
• Excellent communication skills, with a high proficiency in English, written and spoken
• Experience analyzing and writing highly technical reports

This is a two-year project position with a possibility for further employment.  

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.