GVP, Manufacturing

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities

• Lead and manage internal and external DS, DP and device development and manufacturing, analytical development and testing, and technology transfers
• Establish overall development and manufacturing strategies and plans
• Provide strategic direction, technical leadership, and operational execution ensuring successful and timely delivery of preclinical, clinical and commercial supplies
• Develop long-term plans to establish and maintain a robust and scalable development and manufacturing team, enact appropriate risk mitigation procedures, and monitor and identify future trends and needs
• Maintain a high performing team by attracting, retaining and developing talent with an innovative, and agile mindset
• Support budget forecast, manage budget and resources
• Develop effective and efficient working relationships with internal and external partners
• Collaborate with Regulatory Affairs on regulatory strategy. Author and review regulatory submissions and correspondences as needed.
• Work with a diverse cross-functional group of partners to ensure program deliverables and timelines. May lead Tech Ops Core Team for one or multiple programs as needed.
• Support alliance management activities with partners, external vendors, contract manufacturers, and contract testing labs, including vendor assessment, contract review, establishment of KPIs, and vendor performance management, including JSC meetings and Business Review Meetings.
• Represent Tech Ops in cross-functional meetings and provide updates to Senior Management and key stakeholders.
• Provide input on technical, regulatory, and manufacturing aspects as a leader within Technical Operations.
• Stay current with regulatory guidance, industry trends, and new emerging technologies as it relates to development and manufacturing.
• Support and lead innovative opportunities, such as evaluation of artificial intelligence for improving development efficiencies, facility expansion assessment etc., as needed.
• Support due diligence projects.

Qualifications and Experience

• PhD in Pharmaceutical Sciences, Biology, Biochemistry, Chemical/Biochemical Engineering, or related field
• Extensive experience (15+ years) in the biotech pharmaceutical industry, with expertise in development and manufacturing and progression of programs through clinical development and commercialization
• Experience with protein therapeutics development is preferred. Multiple therapeutic modalities a plus.
• 10+ years in a leadership role, with demonstrated record of success.
• Strong leadership and people skills with the ability to work cross-functionally and communicate concisely and effectively.
• Strong technical and scientific experience in product development and commercialization
• Extensive experience with regulations and requirements such as cGMP, ICH, USP, JP and global CMC regulatory expectations and proven track-record of resolving complex issues with health authorities.
• Strong knowledge of phase appropriate regulatory requirements for biologics development.
• Experience authoring regulatory filings and interacting directly with Health Authorities
• Experience in CDMO and vendor evaluation/selection and management
• Analytical thinker. Ability to understand technical, regulatory, and business implications, as well as complex cross-functional considerations in establishing development plans.
• Ability to balance near term objectives with long term goals, scenario plan, evaluate risks and benefits and develop effective solutions.
• Ability to manage multiple priorities and work with ambiguity to deliver results.
• Ability to travel up to 5%.