Sr Manager, CMC Quality (Contractor)

Company Description

Corbus Culture:

Corbus is a close-knit team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill.  At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

About Corbus

Corbus is a precision oncology company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ internal development pipeline includes CRB-701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin 4-on cancer cells to release a cytotoxic payload and CRB-601, and anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

Job Description

Corbus is seeking a CMC Quality Sr, Manager to perform the primary quality review of all post- manufacturing-related documentation for large molecule drug substance and sterile drug products. This role will be a part-time temporary role for about 6 months.

The position directly reports to the Quality program manager.

Responsibilities

• Manager will be responsible for implementing processes for document receipt from contract manufacturing organization, batch packet assembly and transfer to internal quality review team of manufacturing documents, and final submission into the electronic records retention system in compliance with global GxP regulations
• This individual will have the unique opportunity to help design and shape IMVT Quality processes while collaborating with external contract organizations to establish compliant, efficient, measured, and integrated batch review processes at a rapidly growing biotechnology company
• This manager will assemble and perform a technical quality review of executed manufacturing and testing documents provided by the contract manufacturer and laboratories to ensure regulatory compliance with FDA, EMA, ROW and other applicable global health authority requirements that ultimately ensure patient safety
• Manager then will liaise with the Corbus CMC Team and collaborate with the CMO Quality Unit to ensure prompt and thorough resolution to any open matters identified in the technical review

Qualifications

• Bachelor (B.S.) or advanced degree in Biology, Chemistry, Immunology or related fields
• Experience interacting with FDA, EMA, and other global health authorities
• Strong analytical and organizational skills, with attention to detail
• Excellent written, verbal, listening, and interpersonal communication skills
• Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants)
• Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment

Additional Information

All your information will be kept confidential according to EEO guidelines.