Page Mechanical Group, Inc.
Sr Mgr/AD of Technical Operations, Drug Substance
Page Mechanical Group, Inc., Boston, Massachusetts, us, 02298
Position: Sr Manager/Associate Director of Technical Operations, Drug Substance
Learn more about the general tasks related to this opportunity below, as well as required skills.
Department: Tech Ops
Reports to: Senior Director, Technical Operations
Position Description
The Sr Manager/Associate Director of Technical Operations, Drug Substance ensures the drug substance supply for AVEO's approved small molecule therapy (FOTIVDA), a kinase inhibitor for non-resectable RCC patients. This role collaborates closely with AVEO QA, regulatory, and compliance teams, supporting commercial drug supply and is involved in supplying drug substance to a partner for potential ocular/ophthalmic use. The Sr Manager/Associate Director of Technical Operations oversees new process implementation and scale-up, manages data review, CMO relationships, and technical aspects of substance development.
Responsibilities
Reviews data and provides support for the process development at the CMO.
Manages process re-validation at the CMO.
Works with contract analytical laboratories to provide in-process support to drive PD efforts and engineering runs for process modification.
Assure that final drug substance achieves a level of purity sufficient for AVEO and collaborating partner CMO.
Working with AVEO management and the CMO to generate technical protocols, reports and batch records to support the cGMP manufacture of drug substance.
Assists in Defining project timelines to support registrations.
Communicates clearly, efficiently and accurately with internal team members and external partners.
Fully experienced with cGMPs and all applicable regulations and guidance.
Strong technical aptitude including the demonstrated experience of developing and supporting the life-cycle management of synthetic processes.
Must be a self-motivated, highly organized and personable individual capable of seeing tasks through influence of external partners.
Qualifications
PhD in a field such as Organic/Medicinal Chemistry or Chemical Engineering, with a specialization in the manufacturing science of small molecules.
A minimum of five years of hands-on development and/or commercial industry experience in the manufacturing science of synthetic small molecules.
Experience in interacting with external partners and contract manufacturing organizations required.
Experience in collaborating with process development, QC/AD and supply chain/logistics functions in assuring supply of necessary components to assure drug substance timelines are met.
Experience in managing and oversight of failure investigations, development of reports and protocols.
Thorough knowledge of production cGMPs and interactions with Regulatory Authorities.
AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients’ lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit FOTIVDAHCP.com.
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.
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Learn more about the general tasks related to this opportunity below, as well as required skills.
Department: Tech Ops
Reports to: Senior Director, Technical Operations
Position Description
The Sr Manager/Associate Director of Technical Operations, Drug Substance ensures the drug substance supply for AVEO's approved small molecule therapy (FOTIVDA), a kinase inhibitor for non-resectable RCC patients. This role collaborates closely with AVEO QA, regulatory, and compliance teams, supporting commercial drug supply and is involved in supplying drug substance to a partner for potential ocular/ophthalmic use. The Sr Manager/Associate Director of Technical Operations oversees new process implementation and scale-up, manages data review, CMO relationships, and technical aspects of substance development.
Responsibilities
Reviews data and provides support for the process development at the CMO.
Manages process re-validation at the CMO.
Works with contract analytical laboratories to provide in-process support to drive PD efforts and engineering runs for process modification.
Assure that final drug substance achieves a level of purity sufficient for AVEO and collaborating partner CMO.
Working with AVEO management and the CMO to generate technical protocols, reports and batch records to support the cGMP manufacture of drug substance.
Assists in Defining project timelines to support registrations.
Communicates clearly, efficiently and accurately with internal team members and external partners.
Fully experienced with cGMPs and all applicable regulations and guidance.
Strong technical aptitude including the demonstrated experience of developing and supporting the life-cycle management of synthetic processes.
Must be a self-motivated, highly organized and personable individual capable of seeing tasks through influence of external partners.
Qualifications
PhD in a field such as Organic/Medicinal Chemistry or Chemical Engineering, with a specialization in the manufacturing science of small molecules.
A minimum of five years of hands-on development and/or commercial industry experience in the manufacturing science of synthetic small molecules.
Experience in interacting with external partners and contract manufacturing organizations required.
Experience in collaborating with process development, QC/AD and supply chain/logistics functions in assuring supply of necessary components to assure drug substance timelines are met.
Experience in managing and oversight of failure investigations, development of reports and protocols.
Thorough knowledge of production cGMPs and interactions with Regulatory Authorities.
AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients’ lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit FOTIVDAHCP.com.
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.
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