JOB SUMMARY:

The Associate Director  / Director of Technical Operations will help drive the development of our products. Working within the internal organization and with external partners, they will be responsible for managing key business operations projects with a particular focus on strategic commercial/clinical supply agreements and process development contract negotiation, legal review, and contract lifecycle management across the organization’s portfolio. The role will coordinate supply-agreement budgeting with FP&A and work to harmonize favorable business terms across agreements. The role will identify key contract terms and milestones relating to business operations, work closely with project management and manufacturing teams, and escalate key decisions to upper management and project managers.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Manage cross-functional (legal, quality, regulatory, finance, tech-ops) review and approval of supply, development, and other key agreements and contracts for various programs.
• Support change management for SME ownership of business operations.
• Understanding and communication of phase appropriate method development, qualification and development of analytical methods, Tech Transfer of methods and implementation at external partners.
• Adhere to, and drive standardization of business operations and contract management throughout the Technical Operations function.
• Work closely with contract manufacturing organizations to ensure contract negotiations move forward according to established timelines. 
• Coordinate departmental budget preparation with FP&A and stakeholders. Ensure budget owners and other stakeholders track adherence to budget.
• Support technical business owners for business operations process guidance and optimization.
• Identify and communicate key contract terms and milestones to senior department management and project managers and escalate issues to appropriate decision-makers within the organization.
• Occasional travel, as needed.

 EDUCATION AND EXPERIENCE:

• /BEng. with a minimum of 5 years of direct biotech/pharma or related experience. Acceptable combination of education and relevant experience will also be considered.
• Familiarity with biotech manufacturing cycle times, constraints, method development, and working with external CMOS.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to translate financial reports/targets in business actions.
• System integration/data sharing experience preferred.
• Advanced experience with Microsoft office (Excel, Project, etc.) and other reporting tools.
• Demonstrated success while working with highly technically focused teams.
• Ability to articulate strategic value to cross functional stakeholders.
• Excellent writing and oral communication skills.
• Ability to effectively communicate across multiple levels of the organization including senior management.
• Well organized, creative problem solver that works well in a team environment.
• Must be able to travel domestically and internationally approximately 5-10%