Reporting:

Associate Director, Clinical Manufacturing

Description:

We are seeking an experienced Senior OR Lead GMP Manufacturing Technician to join Mariana’s Technical Operations organization, advancing personalized medicine and radiopharmaceuticals to treat a variety of cancers.

Illustrative Breadth of Responsibilities:

• Directly contribute to the production of the next generation of radiotherapeutics for Mariana’s clinical trial programs.
• Provide “on the floor” support during manufacturing operations.
• Mentor/train other operators on cGMP operations and aseptic techniques, as necessary.
• Plan and execute routine production of radiopharmaceuticals.
• Be able to successfully train on aseptic techniques for manufacturing processes, visual inspection, and sterility activities.
• Participate in the process validation, tech transfers, equipment qualification and routine production of all radiopharmaceutical products.
• Monitor the production-related equipment used to ensure proper function and report any maintenance needs to plant engineering.
• Adhere to all applicable procedures, cGLP, cGMPs, cGDPs, SOPs, Radiation Safety, Mariana policies and QMS and any other quality or regulatory requirements.
• Produce and properly record data per SOPs and cGMP guidelines, to support lot release.
• Perform manufacturing operations in a cleanroom environment.
• Comfortable handling and working with radioactive isotopes.
• Support all manufacturing investigations including deviations, OOS, CAPA, and change controls.
• Maintain manufacturing supplies and inventory as appropriate.

Requirements/ Skills:

• Bachelor’s Degree with 5 years of experience working in a cGMP manufacturing environment in the pharmaceutical or biotechnology industry.
• Experience with radiopharmaceuticals highly preferred.
• Experience working in small-batch, bespoke manufacturing environments required.
• Experience working in a controlled or cleanroom environment required.
• Demonstrated experience performing aseptic techniques at a qualified operator level.
• Strong understanding of GMP and cGMP regulations and guidelines.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.
• Good understanding of the radiation safety regulations and guidelines is preferred.
• Comfortable handling radioactivity and following proper ALARA (As Low As Reasonably Achievable) technique.
• Willingness to think and operate independently.
• Team-oriented mindset with no job too big or too small.

Basic Physical Requirements:

• Occasional lifting of 25 pounds.
• Vision correctable to 20/20.
• Comfort measuring and mixing precise amounts of liquid and/or material(s).
• Able to stand for long periods.
• Able to be in a cleanroom for long periods.

Mariana Oncology’s Values

• Building a Legacy
• Execution Excellence
• Courage of our Convictions