Director, Scientific Leader

Job Summary:

The Director, Scientific Leader is responsible for providing technical and CMC regulatory leadership and guidance across the Abzena portfolio, including proposal generation, cross-site programs, and with key partners: Business Development, Alliance and Program Management, Research and Development, including both Early and Late Stage, Operations, and Quality. The Director will be responsible for ensuring scientific input is provided during proposal generation and to project teams, as needed, while working collaboratively with clients and key partners to ensure forward progression of projects.  Working as part of the Scientific Leadership group and in partnership with Abzena stakeholders the Director will enhance Abzena’s technical capabilities from Early Development to Commercial production.  The incumbent will serve as a principal point for contact for clients.

Responsibilities

• Provides support to successfully accomplish company’s projects and goals through the scientific leaders model
• Provides input for the strategic planning effort to help shape corporate strategy
• Provides technical guidance to proposal generation, particularly in area of expertise
• Reviews project proposals for technical soundness, and feasibility, particularly in area of expertise
• Reviews pricing models for proposals in partnership with other functions
• Communicates effectively with clients providing advice and solutions
• Assists Finance and Alliance and Program Management in concert with the ERP system in designing cost & pricing models that accomplish projects on time and on budget
• Develops and works with teams on the evaluation of new molecule designs, developability assessments, DoEs, process improvements, and new technologies
• Helps guide tech transfer processes between sites or within sites
• Collaborates with Alliance & Program Management, and Quality globally to successfully deliver products for regulatory approval and commercial launch
• Provides technical and regulatory leadership to ensure an effective and compliant environment for current and upcoming processes
• Provides a science-based approach for the resolution of deviations, investigations, and process issues
• Recommends strategies for improving molecules, technologies, quality, productivity, and yields
• Ensures that quality is maintained, safety procedures, and company guidelines are followed
• Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups
• Participates in the development of effective working relationships with both internal and external partners
• Maintains client relationships through combination of telephone, teleconference, and onsite visits
• Supports multiple projects simultaneously
• Provides administrative leadership and knowledge-based expertise in related areas that can be applied to meeting strategic goals
• Operates to the highest ethical and moral standards
• Complies with Abzena’s policies and procedures
• Communicates effectively with clients, supervisors, colleagues and staff
• Participates effectively as a team player in all aspects of Abzena’s business
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission
• Performs other duties as assigned

Qualifications/ Skills Required:

• MSc or PhD in a relevant field of engineering or science
• 8 plus years’ experience in technical development of pharmaceutical products gained in Pharma and / or Biotech and /or CRO/CDMO company
• Knowledgeable of all aspects of Biologics and/or Chemistry development, analytical and GMP Manufacturing. Deep knowledge in the specified area of expertise.
• Proven ability to develop constructive and effective relationships with clients, colleagues and senior management
• Ability to demonstrate sound judgement and problem-solving capabilities with exceptional interpersonal skills
• Proven track record of drug discovery, development and manufacture with extensive CMC and GLP/GMP knowledge and experiences
• Experience with developing and executing strategic plans for pre-BLA, Process Validation activities, and product launch activities.
• Solid Financial and Business Acumen
• Previous CMO/CRO experience in biomanufacturing environment
• Excellent oral, written and interpersonal skills in scientific and business communications and presentations
• Expertise in process development and manufacturing of cell culture based products
• Demonstrated experience of development and tech transfer
• Application of scientific and engineering know how to generate innovative yet pragmatic solutions to technical challenges
• Knowledge of cGMP requirements in manufacturing
• Knowledge of CMC regulatory requirements for pharmaceutical products

Leadership

• Strong interpersonal and communication skills
• Ability to influence and negotiate effectively with the aim of delivering projects with both external and internal customers
• Ability to manage and advance multiple activities and projects

Travel between Abzena sites (Bristol PA, San Diego CA and Sanford NC) as needed.  

Physical Requirements: 

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.

FLSA: Exempt

We have communication on the last bullet point and as a responsibility bullet. We can leave it out here. [CR1]