Director of QC
San Diego, CA
Quality – Quality Control /
Full Time /
On-site
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 Director of Analytical Testing is responsible for the management of the QC Analytical Testing Laboratory and the QC Microbiology Laboratory including testing of all relative samples. The leader will be responsible for planning and scheduling of all tests and managing a team of analysts to conduct testing in a reproducible manner. The position requires an exceptional technical leader with a thorough understanding of analytical methodology, leadership attributes, critical thinking skills and problem solving, and 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 amongst 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.
- Comply 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 experience 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 proving relevant documents, materials, scheduling, establishing priorities and meeting deadlines.
$180,000 - $210,000 a year
FLSA:
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.
