What are the responsibilities and job description for the Quality Control Manager, Microbiology position at Mariana Oncology?
Reporting:
Director, Technical Operations
Description:
We are seeking an experienced Quality Control Manager, Microbiology to join Mariana’s Technical Operations organization, advancing personalized medicine and radiopharmaceuticals. This role will serve as an SME for all aspects of microbiological testing including routine environmental monitoring, environmental monitoring performance qualifications, sterility testing to support product release, and bioburden and endotoxin testing. In addition to supporting routine testing, this role will also ensure compliance of current processes with EU Annex 1 and USP guidance.
Illustrative Breadth of Responsibilities:
- Ensure compliance of current processes with EU Annex 1.
- Lead the environmental monitoring program.
- Lead aseptic operator qualification program.
- Lead the aseptic process simulations program.
- Actively trend EM and release data using JMP, Mini-tab, Graphpad prism.
- Experience with raw material testing is considered a plus.
- Identify and procure appropriate laboratory equipment.
- Maintain laboratory equipment in accordance with internal procedures.
- Follow SOPs and stay up to date on regulations.
- Perform data analysis and interpretation.
- Track progress against project timelines, generate regular status updates, and communicate progress and risks to management and cross-functional teams.
- Present findings in team meetings.
- Effectively manage workload with minimal supervision.
- Adhere to safe laboratory practices.
- Multi-task across several projects and manage time effectively to achieve results.
- Experience with managing external vendors is a plus.
- Collaborate cross-functionally with CMC, Manufacturing, and clinical teams.
Requirements/Skills:
- Bachelor’s degree in microbiology or related field with a minimum of seven years of experience working in a GMP environment in the pharmaceutical or biotechnology industry. Experience working with radiopharmaceuticals will be considered as a plus.
- Excellent knowledge EU Annex 1, cGMP and GMP regulations, ICH Guidelines.
- Demonstrated success in managing people with at least two years in a related supervisory function.
- 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.
- Understands chemistry manufacturing and controls (CMC) documentation for novel compounds consistent with requirements for IND, IMPD, MAA, BLA, NDA, ANDA, or other regulatory pathways.
- Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique Strong communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationship
Mariana Oncology’s Principles
- Building a Legacy
- Execution Excellence
- Courage of our Convictions
