Process Development Associate - Aequor Technologies LLC
Thousand Oaks, CA 91320
About the Job
***Manager is requesting candidates college GPA in the supplier notes of the resume if the candidate is willing to disclose.***
8-5pm - Fully Onsite
Experience: Open to a recent graduate with basic lab experience
Nice to have: Cell culture, PCR, biological assays, work with bioreactors and/or AKTA chromatography, and data analytics and visualization knowledge.
Job Summary: The Product Quality Director is the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions and inspections. The PQL has responsibility for driving change to implement operationally efficient processes and corporate alignment across international sites. As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of large and/or small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and *** Quality Management Systems. *** offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to *** but are new to the industry as a whole. Help us to pave new roads for helping patients. This role is directly responsible for the product quality and related activities (e.g., comparability, specifications, stability, annual product review) in support of the Product Development Team (PDT). The PQL provides scientific oversight for the product quality of pivotal and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant GMP system (EDMQ, change control, etc), and support for regulatory audits and responses to questions. The individual is directly responsible to lead a Product Quality Team (PQT), including oversight of the product stability programs, providing indirect staff management and guidance to members of the PQT. Key Responsibilities:? Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for late phase and commercial programs, including actions required for the PQT/APR; specification, comparability, and stability programs; site and method transfers; product quality impact statements for Company; and PQ owned regulatory filing sections and RTQs? Provide expertise in science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide Client solutions to complex issues? Demonstrate proficiency in oral and written communication of complex information to *** leadership, peers and regulatory agencies including communications associated with inspectional activities? Demonstrate proficiency in knowledge of cGMP and international regulatory expectations ? Understand and respond to the impact of emerging scientific/technical trends and their implications for ***? Actively mentor new and existing team members to develop Product Quality core skills 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resourcesPreferred Qualifications:? Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field? Expertise in the areas of protein and small molecule analysis and industry regulations? 8+ years of pharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience? 6+ years working in a regulated environment (direct GMP)? 5+ years managing staff with increasing responsibilities and larger groups? 2+ years experience as a technical expert or product champion? 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation.? 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances? Experience in Project Management in support of product development? Knowledge of protein and small molecule quality, compliance and regulatory requirements? Knowledge of analytical techniques used for protein molecule product quality control? Understanding of drug substance and drug product development and manufacturing? Strong leadership and management skills? General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
8-5pm - Fully Onsite
Experience: Open to a recent graduate with basic lab experience
Nice to have: Cell culture, PCR, biological assays, work with bioreactors and/or AKTA chromatography, and data analytics and visualization knowledge.
Job Summary: The Product Quality Director is the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions and inspections. The PQL has responsibility for driving change to implement operationally efficient processes and corporate alignment across international sites. As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of large and/or small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and *** Quality Management Systems. *** offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to *** but are new to the industry as a whole. Help us to pave new roads for helping patients. This role is directly responsible for the product quality and related activities (e.g., comparability, specifications, stability, annual product review) in support of the Product Development Team (PDT). The PQL provides scientific oversight for the product quality of pivotal and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant GMP system (EDMQ, change control, etc), and support for regulatory audits and responses to questions. The individual is directly responsible to lead a Product Quality Team (PQT), including oversight of the product stability programs, providing indirect staff management and guidance to members of the PQT. Key Responsibilities:? Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for late phase and commercial programs, including actions required for the PQT/APR; specification, comparability, and stability programs; site and method transfers; product quality impact statements for Company; and PQ owned regulatory filing sections and RTQs? Provide expertise in science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide Client solutions to complex issues? Demonstrate proficiency in oral and written communication of complex information to *** leadership, peers and regulatory agencies including communications associated with inspectional activities? Demonstrate proficiency in knowledge of cGMP and international regulatory expectations ? Understand and respond to the impact of emerging scientific/technical trends and their implications for ***? Actively mentor new and existing team members to develop Product Quality core skills 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resourcesPreferred Qualifications:? Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field? Expertise in the areas of protein and small molecule analysis and industry regulations? 8+ years of pharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience? 6+ years working in a regulated environment (direct GMP)? 5+ years managing staff with increasing responsibilities and larger groups? 2+ years experience as a technical expert or product champion? 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation.? 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances? Experience in Project Management in support of product development? Knowledge of protein and small molecule quality, compliance and regulatory requirements? Knowledge of analytical techniques used for protein molecule product quality control? Understanding of drug substance and drug product development and manufacturing? Strong leadership and management skills? General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
Source : Aequor Technologies LLC