Senior Scientist Quality Control

Description

Oncoinvent AS is looking for a Senior Scientist to strengthen the Quality Control team at the company manufacturing facility in Oslo. The position is an exciting opportunity to work in an innovative and dynamic start-up company and participate in the development of novel pharmaceuticals.

The successful candidate will together with the Quality Control team be responsible for quality control of raw materials, drug substance (Ra-224) and drug product (Radspherin®)

Key responsibilities

• Develop analytical methods for testing of raw materials, intermediates and finished product
• Leads / participates in the validation of test methods
• Conduct chemical and physical release testing of raw materials, intermediates, finished product and stability samples
• Contribute to development of specifications for raw materials, intermediates, and finished product
• Investigate deviations and closing of the records in a timely fashion
• Resolve, in collaboration with the QC, QA and production team, out-of-specification or unexpected results and analytical and product problems
• Maintains and troubleshoots analytical instrumentation as needed. Performs audits on equipment periodically to verify proper calibration and use
• Records and reports results of analysis in accordance with prescribed lab procedures and systems
• Prepare and files regulatory documents
• Track progress against project plans, generate regular status updates, and communicate progress and issues
• Coordinates and leads writing of SOPs, policy manuals, and other instructional documents
• Procurement and qualification of analytical instruments
• Contribute in internal audits of contract manufacturer/laboratories
• Follow up Contract Research Organization. Ensure good communication and cooperation with research organizations, contracts manufacturer and laboratories
• Technology transfer of analytical test methods to secondary Manufacturing Site

Qualifications and experience

The holder of the QC Senior Scientist position should have the following documented qualifications and experience:

• M.Sc./ Ph.D. in analytical, organic or inorganic chemistry
• Strong knowledge in analytical chemistry principles
• Minimum 10 years practical, hands-on experience in development of analytical methods and validation
• Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control
• Strong problem-solving, troubleshooting and written/oral communication skills
• Knowledge from technology transfer of analytical methods
• A successful candidate will have to be able to work in a multidisciplinary team while being able to plan and perform practical work independently

Location

The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo. The position will report to the Head of Quality.

About Oncoinvent

Oncoinvent is a privately held Norwegian company based in Nydalen, Oslo. The company is committed to developing novel, innovative products to provide better treatment options for cancer patients. The Oncoinvent team consists of 24 employees and the company is growing. In December 2017 Oncoinvent finished building a state-of-the-art manufacturing facility to produce drug product intended for use pre-clinical and early phase clinical trials.