CMC Operations Manager at Alpha-9 Oncology in Boston, Massachusetts

Job Description:

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking a Manager of CMC Operations to support CMC activities for our growing clinical-stage pipeline of radiopharmaceutical products. This person will be responsible for technical project management of activities associated with clinical stage manufacturing and will serve as a point of contact for our external contract development and manufacturing organization (CDMO) partners. We are seeking a candidate with a degree in a scientific discipline and a track record of operational as well as scientific/technical contributions in previous roles.

As a start-up organization, we value team members eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Some specific duties and tasks include, but are not limited to, the following:

* Manage external CDMO partner and supplier relationships from initial project proposal through delivery of materials.

* Drive execution of the CMC strategy for nonclinical and clinical programs by researching and designing experiments for radiopharmaceutical formulation development in preparation for CDMO technology transfer and validation activities.

* Collaborate with cross-functional internal teams (Business Development, R&D, Pre-clinical, Clinical and Regulatory) to achieve CMC program goals and timelines.

* Partner with internal R&D and CMC laboratory personnel for development of robust radiolabeling processes and clinical formulations that meet target product profiles for diagnostic and therapeutic applications.

* Critically evaluate data, draw appropriate conclusions and develop follow-up plan of action. Ability to troubleshoot, identify unusual results and design experiments that establish root cause and/or enhance knowledge of the product being developed.

* Develop and take ownership of short-term and long-range CMC project plans and budgets.

* Drive review and approval of technical documents and reports by leveraging strong partnerships with internal and consultant subject matter experts (SMEs).

* Ensure delivery of nonclinical and clinical supplies according to required timelines; maintain material inventories.

* Proactively identify resource constraints, develop mitigation strategies, and establish contingency plans to avoid program delays.

* BS degree in a scientific discipline. Advanced degree in chemistry, biochemistry, radiochemistry, or related field is preferred.

* Minimum of 5 years of relevant experience in pharmaceutical or biotechnology industry. Peptide manufacturing or radiopharmaceutical experience is ideal.

* Strong communication skills, ability to build strong relationships at all levels of the organization.

* Track record of successfully driving and managing CMC development and/or clinical supply programs.

* Strong problem-solving and organizational skills.

* Ability to independently identify external resources to bridge gaps and enhance our internal capabilities.

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