GMP Manufacturing Technician

3 weeks ago

Watertown, United States Mariana Oncology Full time
Reporting

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. Who want to be part of building a successful biotech, and in honing their knowledge and experiences to enhance their careers.

We are based in Arsenal Yards in Watertown, MA. We have our office space, research labs, and GMP manufacturing suite all in one place, with a beautiful surrounding area within Arsenal Yards.

We are seeking an experienced GMP Manufacturing Technician to join Mariana's Manufacturing organization, advancing personalized medicine and radiopharmaceuticals.

Illustrative Breadth of Responsiblities
  • Directly contributing to the production of the next generation of radiotherapeutics for Mariana's clinical trial programs
  • Planning and executing routine production, packaging, and shipping of radiopharmaceuticals
  • Following aseptic techniques for manufacturing processes, line clearances, and sterility activities
  • Participating in the process validation, tech transfers, equipment qualification and the production of all radiopharmaceutical drug product for supporting Mariana's clinical trial programs
  • Monitoring of the production-related equipment used to ensure proper function and report any maintenance needs to plant engineering.
  • Adhering to all applicable procedures, cGLP, cGMPs, cGDPs, SOPs, Radiation Safety, Mariana policies and QMS and any other quality or regulatory requirements
  • Producing and properly recording data per SOPs and cGMP guidelines, to support lot release and CoA generation while closely working with Quality Assurance team.
  • Performing various activities in a clean room environment
  • Maintaining and performing routine environmental monitoring procedures per SOPs.
  • With the QA department, supporting all investigations, manufacturing deviations, OOS, CAPA and customer complaints
  • Performing required package testing activities/DOT requirements for release of radiopharmaceuticals for delivery
  • Maintaining manufacturing supplies and inventory as appropriate
  • Contributing to overall CMC strategy development and capacity planning

Requirements/Skills:

  • Bachelor's Degree, Associate Degree, or 5 years of experience working in a GMP manufacturing environment in the pharmaceutical or biotechnology industry. Experience working with radiopharmaceuticals is preferred
  • Experience working in a controlled or cleanroom environment preferred
  • General knowledge and experience performing aseptic techniques
  • GMP and cGMP experience, as well as knowledge of GMP and cGMP regulations, and guidelines
  • Technically oriented and able to troubleshoot basic mechanical equipment issues and interface with varied software programs
  • 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
  • General understanding of 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 following proper ALARA (As Low As Reasonably Achievable) technique
  • Communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships

Mariana Oncology's Values

  • Building a Legacy
  • Execution Excellence
  • Courage of our Convictions

What Success Looks Like at Mariana Oncology

Entrepreneurial Mindset

You have an opportunity to create part of an overall function, bringing all your knowledge, skills and experiences to bear with the thinking that enables you to overcome challenges, be decisive, and accept responsibility for your outcomes. We are all working in an exciting and new space of life sciences, that tests us in a way where we need to improve skills, learn from mistakes, and take continuous action on ideas. You have to do the right thing, but not at any cost. The Entrepreneurial mindset involves a steadfast commitment our goals, allowing you to carry out the necessary steps to accomplish your work without letting the demands of the day can get in your way, and creating a space where you need to think to retain creativity and flexibility.

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. You will find yourself in challenging situations, working with very smart people, and approaching work, issues and elements of your job without a lot of direction. You won't know it all (we don't either). You need to feel confident that the answers are sometimes best found when working collaboratively and with your team.

Leadership

We are all leaders in one way or another, whether you are early in career, new to industry or an executive at the company. We lead and influence with our ideas, with our bodies and our minds. You will serve as a role model and as someone who inspires others to constantly strive to do better/be their best. We need you to think and work across the enterprise. You need to be able to empower others, be able to influence without authority, and be a positive force for changes. We need you to also manage resources effectively.

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