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Associate Director/Director Upstream Process Development - Boston, United States - Page Mechanical Group Inc
Description
Position:
Associate Director/Director Upstream Process Development & Technical Operations
Department:
Technical Operations
Reporting to:
Sr. Director Technical Operations
Location:
Remote
Summary:
The Associate Director/Director Upstream Process Development and Technical Operations will be directly responsible for the process development and technical manufacturing elements of AVEO's biologics drug substance programs.
This highly visible position will report to the Senior Director of Technical Operations and will have oversight into early and late stage development of biologics processes at AVEO's CMOs & CDMOs.
They will be responsible for ongoing execution of biologics manufacturing as well as process development, optimization and process characterization activities for late stage assets.
In addition to technical competencies, this position will be required to work in a heavily matrixed organization across supply chain, quality, regulatory functions to assure delivery of material for patients.
Responsibilities:
This individual will be accountable for the following activities:
Upstream subject matter expert for biologics assets.
Cell banking of master and working cell banks.
Creating development scopes of work associated with upstream process development and optimizations at CDMO partners.
Supporting development work and execution at Aveo's CMO/CDMO partners and is the subject matter expert on upstream related events
Leading manufacturing technology transfer activities to external manufacturing partners.
Upstream subject matter expert for process characterization, process validation and CPV related activities post commercialization
Subject matter expertise on regulatory queries relating to the upstream process
Leading process optimization associated with late stage process development including cell line development and process intensification
Requirements:
BS/MS/PhD in chemical engineering, biology, biochemistry or closely related field
Commensurate with educational qualifications, 8+ years of experience in process development, biologics manufacturing, technical services or related area
Subject matter expertise in mammalian cell culture; with familiarity in downstream/purification operations and alternative modalities including microbial fermentation or viral vector production
Experience working with CMOs/CDMOs and directing work at these third parties
Technical degree or equivalent (BS/MS), preferably in a scientific or pharmaceutical discipline.
Experience working within cGMP guidances and any applicable regulations
Being comfortable with working in a highly visible and highly accountable role within a matrix team organization
Must be a self-motivated, highly organized, and personable individual capable of seeing tasks through influence of internal and external partners.
About
AVEO:
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer.
AVEO currently markets FOTIVDA (tivozanib) in the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development.
AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
