Reporting:

Carey Nasta, Associate Director, Clinical Manufacturing

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 radio ligands targeting cancer tumors while mitigating destruction to healthy tissue and cells. We have built a fully integrated, leading radiopharmaceutical platform, that is 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 Senior Manager, Quality Control to join Mariana’s Clinical Manufacturing organization, advancing personalized medicine and radiopharmaceuticals. You will be responsible for the Quality Control of our clinical therapies produced in our GMP manufacturing suite in Watertown. This person will play a pivotal role in creating and maintaining the highest standard of excellence for our therapies to treat cancer patients.

Illustrative Breadth of Responsibilities:

• Work collaboratively with cross-functional team to support release and quality control testing for drug substance, drug product and raw materials at the external vendors, in support of CMC and clinical program timelines.
• Participating in the process validation, equipment qualification and the quality testing of all radiopharmaceutical drug products for supporting Mariana’s clinical trial programs.
• Perform analytical testing for in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, HPLC, TLC, GC, etc.
• Troubleshoots problems associated with methods and instruments resolving them where possible or seeking guidance/authorization where required.
• Develop/revise documentation such as SOP, testing procedures and material specifications.
• Monitoring of all analytical equipment used to ensure proper function and report any maintenance needs, as well as coordinate all preventative maintenance with third party vendors.
• Adhering to all applicable procedures, cGLP, cGMPs, cGDPs, Mariana policies and QMS and any other quality or regulatory requirements.
• Reviewing and analyzing analytical data to support lot release and CoA generation while closely working with Quality Assurance team.
• Participate in components control and materials acceptance.
• With the QA department, participate in investigations associated with quality testing deviations, OOS, or CAPAs.
• Ensuring all direct reports are properly trained in areas directly related to their job responsibilities as well as company policies, quality policies, and safety/environmental policies.
• Recording, processing, compiling, and interpreting experimental data and results, and presentation of data in a cross-functional setting.
• Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement.

Requirements/Skills:

• Bachelor’s degree in a technical discipline (Biology, Chemistry, or related field) with at least five years of experience working in a GMP testing environment in the pharmaceutical or biotechnology industry. Experience working with radiopharmaceuticals will be considered as a plus.
• Knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines and local country drug shipment regulations.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.
• Strong technical experience with HPLC based methodologies, and operational knowledge of analytical instruments.
• 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

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. Sometimes, even something as simple as saying, “thank you” or “great work” can go a long way.

Leadership:

We’re looking for role models who can think and work across the enterprise and inspire others to perform at their very best. If you are passionate about improving the lives of people suffering from cancer, empowering others, and being a positive force for change, then join us. Together we can defeat cancer’s toughest tumors!