Associate Director, Analytical Development

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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 Associate Director will be accountable for the day-to-day oversight, leadership and direct management of the Analytical Development team. The position is further accountable for maintaining the Analytical laboratory in a highly optimized operational state and ensuring that laboratory quality, documentation and safety standards are adhered to. The individual will work closely with the Sr. Director and the Analytical Team on the development and optimization of analytical methods needed to support process development, in-process monitoring, drug substance and drug product release/stability testing, establishment of specifications, and writing of method qualification/validation protocols and reports to support client regulatory submission.

The successful candidate will possess extensive analytical knowledge, highly refined communication skills and a demonstrated track record of leading highly functional analytical teams.

Responsibilities

• Responsible for oversight, leadership and management of the Analytical team
• Accountable for maintaining the Analytical laboratory in a highly optimized functional state and ensuring that laboratory quality and safety standards are rigorously adhered to
• Responsible for maintaining, optimizing and expanding sample and knowledge management systems
• Develops efficient, optimized processes to maximize work volume in a fast-paced client-based environment while balancing client requests with contracted scope of work
• Accountable for maintaining a high-level of scientific rigor for all outputs of the team (methods, client updates, reports, data, etc)
• Anticipates potential capacity issues and proactively communicates those issues to site leadership
• Ensures the team activities remain within the recognized budget
• Extensive experience with methods and instrumentation related to the following:, ELISA based assays (impurities and binding), cell based potency assays based on MOA, molecular biology, etc
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission
• Performs other duties as assigned

• PhD in chemistry, biology, biochemistry, or related discipline, with a minimum of 8-10 years of relevant experience in the biopharmaceutical industry with 3-5 years of experience in a leadership role, or MS with 12-15+ years of relevant experience, including 3-5 years of leadership experience
• Extensive knowledge of USP, ICH, EP, FDA, 21 CFR, and other guidance documents
• People manager with ability to achieve results through teamwork and leadership of others, streamlined execution, and innovation
• Strong verbal and written communication skills
• Demonstrated ability to develop constructive and effective relationships with direct reports, colleagues, and senior management