Abzena
QC Director, Analytical
Abzena, Bristol, Pennsylvania, United States, 19007
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The QC Director is responsible for all activities supported by the site QC Analytical Testing Laboratory in a CDMO that provides GMP ADC Manufacturing capability to the Biopharmaceuticals industry. The QC team accepts transfer of analytical methods from the Analytical Development team, performs in-process testing in support of manufacturing, performs release and stability testing on small molecule process intermediates and ADC drug substance, and raw materials release testing. The position requires an exceptional technical leader with a thorough understanding of analytical methodology and problem solving using outstanding team management skills.
Responsibilities
Provides strategic and scientific oversight to the Analytical Testing laboratoryEnsures the analytical control strategy is aligned with Abzena's sourcing strategy for productsProvides support to Operations and Quality staff in responding to client requests that require scientific and/or regulatory informationOperates as the primary contact to other departments such as Project Management, Manufacturing, and Quality Assurance relevant to project execution activitiesProvides support to clients and operations staff in day-to-day operations to develop sound scientific and regulatory compliant solutions in the design, execution and evaluations of studies, including addressing deviations and unexpected resultsParticipates in and prepares responses to both internal and external technical and quality assurance audits as requiredPerforms quality review and analysis of laboratory data, protocols and reportsSupports quality in the development of short-range and long-range operating objectives, budget, organizational structure, staffing requirements, and succession plansEnsures a continued information flow among other departments and external collaborators/partnersRepresents Analytical testing strategies to regulatory authorities, clients, and inspections/auditsContributes to development of an operating model and continuous improvement of platform methodsDemonstrates administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena's strategic goalsContributes to Quality Control department goals and objectivesOperate to the highest ethical and moral standardsEnsures compliance with Abzena's policies and proceduresCommunicate effectively with clients, supervisors, colleagues and staffParticipate effectively as a team player in all aspects of Abzena's businessAdhere to quality standards set by regulations and Abzena policies, procedures, and missionPerform other related duties as assignedQualifications
PhD, MS or BS virology, biochemistry molecular biology or related disciplines, along with relevant experience10 or more years of experience in the biotechnology, or pharmaceutical industry. Strong background in Quality Control Analytical Development and Quality Control with biologics development experienceDemonstrated leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, analytical method development, technology transfer, method qualification/validation and process developmentExperience in a cGMP environment and have a solid understanding of GMPExcellent communication, interpersonal, organizational, writing and managerial skillsRegulatory agency interaction experience preferredcGMP compliance training, method development, qualification and validation experiencesStrong organizational skills and attention to detail for composing and proofing relevant documents, materials, scheduling, establishing priorities and meeting deadlines
FLSA:
Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The QC Director is responsible for all activities supported by the site QC Analytical Testing Laboratory in a CDMO that provides GMP ADC Manufacturing capability to the Biopharmaceuticals industry. The QC team accepts transfer of analytical methods from the Analytical Development team, performs in-process testing in support of manufacturing, performs release and stability testing on small molecule process intermediates and ADC drug substance, and raw materials release testing. The position requires an exceptional technical leader with a thorough understanding of analytical methodology and problem solving using outstanding team management skills.
Responsibilities
Provides strategic and scientific oversight to the Analytical Testing laboratoryEnsures the analytical control strategy is aligned with Abzena's sourcing strategy for productsProvides support to Operations and Quality staff in responding to client requests that require scientific and/or regulatory informationOperates as the primary contact to other departments such as Project Management, Manufacturing, and Quality Assurance relevant to project execution activitiesProvides support to clients and operations staff in day-to-day operations to develop sound scientific and regulatory compliant solutions in the design, execution and evaluations of studies, including addressing deviations and unexpected resultsParticipates in and prepares responses to both internal and external technical and quality assurance audits as requiredPerforms quality review and analysis of laboratory data, protocols and reportsSupports quality in the development of short-range and long-range operating objectives, budget, organizational structure, staffing requirements, and succession plansEnsures a continued information flow among other departments and external collaborators/partnersRepresents Analytical testing strategies to regulatory authorities, clients, and inspections/auditsContributes to development of an operating model and continuous improvement of platform methodsDemonstrates administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena's strategic goalsContributes to Quality Control department goals and objectivesOperate to the highest ethical and moral standardsEnsures compliance with Abzena's policies and proceduresCommunicate effectively with clients, supervisors, colleagues and staffParticipate effectively as a team player in all aspects of Abzena's businessAdhere to quality standards set by regulations and Abzena policies, procedures, and missionPerform other related duties as assignedQualifications
PhD, MS or BS virology, biochemistry molecular biology or related disciplines, along with relevant experience10 or more years of experience in the biotechnology, or pharmaceutical industry. Strong background in Quality Control Analytical Development and Quality Control with biologics development experienceDemonstrated leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, analytical method development, technology transfer, method qualification/validation and process developmentExperience in a cGMP environment and have a solid understanding of GMPExcellent communication, interpersonal, organizational, writing and managerial skillsRegulatory agency interaction experience preferredcGMP compliance training, method development, qualification and validation experiencesStrong organizational skills and attention to detail for composing and proofing relevant documents, materials, scheduling, establishing priorities and meeting deadlines
FLSA:
Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.