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 laboratory
- Ensures the analytical control strategy is aligned with Abzena's sourcing strategy for products
- Provides support to Operations and Quality staff in responding to client requests that require scientific and/or regulatory information
- Operates as the primary contact to other departments such as Project Management, Manufacturing, and Quality Assurance relevant to project execution activities
- Provides 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 results
- Participates in and prepares responses to both internal and external technical and quality assurance audits as required
- Performs quality review and analysis of laboratory data, protocols and reports
- Supports quality in the development of short-range and long-range operating objectives, budget, organizational structure, staffing requirements, and succession plans
- Ensures a continued information flow among other departments and external collaborators/partners
- Represents Analytical testing strategies to regulatory authorities, clients, and inspections/audits
- Contributes to development of an operating model and continuous improvement of platform methods
- Demonstrates administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena's strategic goals
- Contributes to Quality Control department goals and objectives
- Operate to the highest ethical and moral standards
- Ensures compliance with Abzena's policies and procedures
- Communicate effectively with clients, supervisors, colleagues and staff
- Participate effectively as a team player in all aspects of Abzena's business
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission
- Perform other related duties as assigned
Qualifications
- PhD, MS or BS virology, biochemistry molecular biology or related disciplines, along with relevant experience
- 10 or more years of experience in the biotechnology, or pharmaceutical industry. Strong background in Quality Control Analytical Development and Quality Control with biologics development experience
- Demonstrated leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, analytical method development, technology transfer, method qualification/validation and process development
- Experience in a cGMP environment and have a solid understanding of GMP
- Excellent communication, interpersonal, organizational, writing and managerial skills
- Regulatory agency interaction experience preferred
- cGMP compliance training, method development, qualification and validation experiences
- Strong organizational skills and attention to detail for composing and proofing relevant documents, materials, scheduling, establishing priorities and meeting deadlines
FLSA: ExemptAbzena 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.