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Quality Control Analyst I/ii
4 months ago
**Reporting**:
Associate Director, Quality Control
**Description**:
Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best-in-class alpha
- and beta-emitting radioligands that target cancer, while mitigating destruction to healthy tissue and cells. We have built a fully-integrated, leading radiopharmaceutical platform, bringing together novel target biology insights, innovative multimodal ligand discovery, and enabling translational infrastructure.
We are actively seeking talented individuals to join us who are looking to make an impact in science and in the lives of cancer patients. Our team is a collective group who is excited about being part of building a successful biotech company, and in honing their knowledge and experience to enhance their careers.
We have just moved into beautiful new offices in Arsenal Yards in Watertown, MA. In our new home we now have our office space, research labs, and GMP manufacturing suite all in one place.
We are seeking an experienced **Quality Control Analyst** I/II to join Mariana’s **Clinical Manufacturing **organization, advancing personalized medicine and radiopharmaceuticals. You will be responsible for supporting the release and stability testing of our clinical therapies produced in our 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.
***Illustrative Breadth of Responsibilities**:
- Supports equipment qualification, method qualification, and the quality testing of all radiopharmaceutical drug products for supporting 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.
- An understanding of analytical method development, transfer, and early stage validation.
- Supports the troubleshooting of problems associated with methods and instruments resolving them where possible or seeking additional guidance.
- Supports the revision of documentation such as SOPs and testing procedures.
- Adhering to all applicable procedures, cGLP, cGMPs, cGDPs, Mariana policies, QMS, and any other quality or regulatory requirements.
- Reviewing and analyzing analytical data to support lot release while closely working with Quality Assurance team.
- Recording, processing, compiling, and interpreting experimental data and results, and presentation of data in a cross-functional setting.
- Effectively manage workload with mínimal supervision.
- Adhere to safe laboratory practices.
- Multi-task across several projects and manage time effectively to achieve results.
- Collaborate cross-functionally with clinical and CMC teams.
**Requirements/Skills**:
- Bachelor’s degree with 2-4 years of experience or master’s degree in biochemistry, chemistry or related discipline with 0-2 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 and ICH Guidelines.
- Commitment to maintain data integrity through strict adherence to standard operating procedures and policies.
- Good understanding of the radiation safety regulations and guidelines is preferred.
- Strong communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
- 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
**What Success Looks Like at Mariana Oncology**
**Entrepreneurial Mindset**:
We are all working in an exciting and new space of life sciences, and the only way we’re going to be successful is by working together. We will be tested in ways that require us to improve our skills, learn from our mistakes, and take continuous action on ideas. By sharing our work, explaining our processes, and highlighting the takeaways we derive from our experiments, we will all learn and grow as a team.
**Believing the Glass is Half-Full and Having Self-Confidence**:
We need you to bring all your courage and willingness to advocate positions based on doing the right things; identify and focus on the positives and potential of every business and scientific opportunity. There will be times when we’re in uncharted territory and working without a lot of direction. When things get challenging, we must look out for each other.
