Senior Analyst I/II, Analytical Quality Control

Manager, Analytical Quality Control

We are seeking an experienced Senior Analyst I/II to join Mariana’s Analytical Quality Control team, advancing personalized medicine and radiopharmaceuticals. This role will be responsible for supporting analytical method transfer activities as well as release and stability testing of our clinical therapies produced in our state-of-the-art GMP manufacturing suite in Watertown. This person will play a role in creating and maintaining the highest standard of excellence for our therapies to treat cancer patients.

·       Support analytical method development activities.

·       Serve as point of contact for analytical method transfer and qualification activities.

·       Support release, in-process, and stability testing of all radiopharmaceutical drug products to support Mariana’s clinical trial programs.

·       Demonstrate initiative to perform routine QC responsibilities such as sample lifecycle, lab equipment maintenance, QC documentation, QC inventory control and reconciliation of sample requests/documents as needed.

·       Troubleshoot problems associated with analytical methods and instruments resolving them where possible or seeking additional guidance.

·       Support the revision of documentation such as SOPs and testing procedures.

·       Adhere to all applicable procedures, cGLP, cGMPs, cGDPs, Mariana policies, QMS, and any other quality or regulatory requirements.

·       Review and analyze analytical data to support lot release while closely working with Quality Assurance.

·       Record, process, compile, and interpret experimental data and results, and present data in a cross-functional setting.

·       Adhere to safe laboratory practices.

·       Multi-task across several projects and manage time effectively to achieve results.

·       Bachelor’s degree or master’s degree in chemistry or related discipline with 3-6 years of experience working in a GMP quality control testing environment in the pharmaceutical or biotechnology industry. Experience working with radiopharmaceuticals will be considered as a plus.

·       Working knowledge of cGMP regulations in addition to USP, ICH, and Annex 1 Guidelines.

·       Commitment to maintain data integrity through strict adherence to standard operating procedures and policies.

·       Experience with HPLC is required.

·       Good understanding of the radiation safety regulations and guidelines is a plus.

·       Strong communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.

·       Comfortable handling radioactivity and following proper ALARA (As Low as Reasonably Achievable) techniques.

·       Role may require off-hours support to accommodate release of clinical product. 

Mariana Oncology’s Principles

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