What are the responsibilities and job description for the Senior OR Lead GMP Manufacturing Technician position at Mariana Oncology?
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 required.
- 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
