Senior Manager, CMC Quality Assurance - Remote

Company:

At Arch Oncology, we are aiming high to discover and develop new antibody therapeutics to treat patients living with cancer. We are committed to advancing antibodies with best-in-class potential. 

Our next-generation anti-CD47 antibodies are highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class.  Our antibodies work by blocking the “don’t eat me” signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, our antibodies also directly kill tumor cells. Importantly, our antibodies bind preferentially to tumor cells, instead of to normal cells, and bind even more potently to tumors in their acidic microenvironment (low pH). Expanding our fight against cancer, we are advancing our lead anti-CD47 antibody AO-176 into clinical development for the treatment of patients with solid tumors.

We are aiming high in our fight against cancer. We are a team of highly experienced and driven professionals who are committed to excellence in all that we do. Our leadership team has successfully developed new drugs before. We know what we need to do to collaborate and execute to get the job done. If you share this commitment and want to work with a team that is focused on helping patients, come aim high with us and apply.

Position Location:

At Arch Oncology, we have two bases. Our headquarters is in Brisbane, CA, a gateway of biotechnology innovation, and our scientific research laboratory is in St. Louis, MO, home of the Gateway Arch.  

This position will be full time remote with occasional travel. 

Reports To:

Senior Director, Head of Regulatory Affairs and Quality Assurance

Job Description and Responsibilities:

The role of Senior Manager, Quality Assurance Operations. Reporting to the Senior Director, Head of Regulatory Affairs & Quality Assurance, will manage and streamline all GMP/GLP quality operations across the organization. This individual will collaborate and partner closely with the CMC organization and contract sites to ensure day-to-day activities maintain compliance under GMP/GLP/FDA regulations.

Primary Responsibilities:

·       Responsible for reviewing and approving CMC/stability protocols and reports, master batch records, material/product  specifications, executed batch records etc.

·       Provide quality assurance oversight for production, testing and release of packaging activities at vendor(s)

·       Responsible for lot dispositions of Arch clinical products

·       Provide quality oversight to change controls, laboratory OOS or OOT, GMP/GLP deviations, CAPAs, shipping excursions and product complaints, as needed.

·       Assist in product quality support in the field (temperature excursions, shipping etc.).

·       Manage the review and approval of tech transfers, characterizations, method qualifications, validation and verification protocols and reports.

·       Develop partnerships with CMOs and test laboratories.

·       Coordinate and/or perform audits of suppliers and service providers as needed.

·       Escalate quality issues to Sr Director of Quality Assurance.

·       Collaborate with the Sr Director of Quality Assurance on the execution of quality strategy, including SOP drafting/review/updates.

·       Support the review of upcoming IND filing including amendments and final check documentation.

·       Other quality projects as determined appropriate by Head of Quality.

Education & Experience:

·       Bachelors or Advanced degree in a scientific discipline (chemistry, biology, microbiology, or equivalent)

·       Minimum of 8 years in biopharmaceutical quality related roles 

·       Experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality

·       Working experience and knowledge of GMP/GLP/FDA guidelines required.

·       Prior experience with the oversight, review, and management of master batch records, protocols, reports, and materials/product specifications.

·       Management of change controls, deviations, laboratory OOS, CAPAs, shipping excursions, and product complaints.

·       Prior experience with the review and approval of tech transfers, method qualifications, validation, and verification protocols/reports.

·       Coordination/conduct of audits of suppliers and service providers.

·       Strong interpersonal skills, ability to interact, communicate and collaborate effectively with individuals from multiple departments at all levels of the organization.

·       Strong organizational and time management skills.

·       Experience establishing and maintaining partnerships with CMOs is preferred.

·       Experience with the review of regulatory submission documentation such as INDs is preferred. 

Benefits:

Arch Oncology offers a generous benefits package including medical, dental, vision, and disability insurance, as well as paid time off and a 401k plan. Arch Oncology, Inc. has implemented a mandatory COVID-19 vaccination policy for all employees.  The Company will provide reasonable accommodations to individuals who are prevented from receiving the vaccine due to a medical reason or a sincerely held religious belief, practice, or observance when required by applicable law unless such accommodations would impose an undue hardship, but does not expect to consider exceptions from the mandatory vaccination policy for other reasons.  New employees will be required to be fully vaccinated and show documentation of their fully vaccinated status or receive a Company-approved medical or religious exemption prior to their first day of employment. 

Arch Oncology is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.