Remote 
Manager/Senior Manager, Biologics Drug Product
 AVEO Pharmaceuticals | |
 United States | |
 Jan 22, 2025 | |
|
JOB TITLE: Manager/Senior Manager Biologics Drug Product
DEPARTMENT: Technical Operations/Biologics CMC REPORTS TO: Sr. Director Technical Operations LOCATION: Remote (Boston or Raleigh NC) DATE PREPARED: January 22, 2024 JOB SUMMARY: The Manager or Senior Manager Biologics Drug Product will be responsible for all aspects of drug product process development, formulation development and manufacturing support for AVEO's biologics portfolio. This highly visible position will report to the Senior Director of Technical Operations and will have oversight into early and late-stage development of parenteral drug product processes at AVEO's CMOs & CDMOs. They will be responsible for ongoing execution of fill & finish 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, and regulatory functions to assure delivery of material for patients. PRINCIPAL DUTIES: This individual will be accountable for the following activities: * Subject matter expert for formulation and drug product process development. * Fill & finish manufacturing of parenterals (particularly biologics). * Creating development scopes of work associated with formulation development and drug product process optimizations at CDMO partners. * Supporting development work and execution at Aveo's CMO/CDMO partners as person in plant and is the subject matter expert for drug product. * Leading manufacturing technology transfer activities to external manufacturing partners. * Formulation & drug product subject matter expert for process characterization, process validation and CPV related activities post commercialization. * Subject matter expertise on regulatory queries relating to the drug product process. * Work closely with the clinical teams to address queries and concerns regarding material compatibility associated with the drug product. * Address Regulatory and/or Qualified Person related queries regarding the drug product. REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS): * BS/MS/PhD in chemical engineering, biochemistry, chemistry or closely related field with emphasis on protein chemistry. * Commensurate with educational qualifications, 5+ years of experience in process development, biologics manufacturing, technical services or related area. * Subject matter expertise in protein biochemistry, formulation development, drug product manufacturing - specifically aseptic filling. * Strong appreciation of aseptic technique and sterility assurance as it relates to parenteral products. * Experience working with CMOs/CDMOs and directing work at these third parties. * Experience working within cGMP guidances and any applicable regulations. * Strong appreciation for phase appropriate approaches to manufacturing. * 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. * Communicates clearly, efficiently, and accurately with internal team members and external partners. * Up to 25% travel would be required from time to time in order to support activities at AVEO's CMO/CDMO sites. * Although this is a Remote based position, preference will be given to candidates who are either based in the Boston, MA area or Raleigh, NC. 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 U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several 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. | |