GVP - Manufacturing

Gavroche; Lexington (MA); On-site; USD 359,000 - 390,000; Full time

Job summary

Kiniksa Pharmaceuticals in Lexington, MA seeks a Group VP of Manufacturing to lead internal and external development and manufacturing activities, including device development, analytics, and technology transfers. You will set strategy and drive execution across programs to ensure reliable supply from preclinical to commercial stages.

The role requires a PhD and 15+ years in biotech manufacturing, strong cGMP expertise, and demonstrated leadership in regulatory submissions and vendor management.

Qualifications

• PhD in Pharmaceutical Sciences, Biology, Biochemistry, Chemical/Biochemical Engineering, or related field.
• 15+ years in biotech manufacturing/development with leadership responsibilities.
• Experience with product development through commercialization and regulation.

Responsibilities

• Lead internal and external DS, DP and device development and manufacturing, analytical development and testing, and tech transfers.
• Establish development and manufacturing strategies and plans.
• Provide strategic direction and operational execution to deliver preclinical, clinical, and commercial supplies.
• Build a scalable development and manufacturing organization and manage risk.

Skills

Leadership

Cross-functional

Regulatory strategy

Regulatory filings

Biologics development

CDMO management

cGMP compliance

Program management

Strategic planning

Communication

Education

PhD in Pharmaceutical Sciences / related field

Tools

CDMO/vendor mgmt

Job description

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

Reporting to the Chief Technical Officer, the Group VP of Manufacturing will lead the internal and external development and manufacturing, including internal and external DS, DP and device development and manufacturing, analytical development and testing, and tech transfers. He/She will collaborate with leaders within Tech Ops to establish and execute development and manufacturing strategies for all programs. This is a senior position within Technical Operations and will be expected to leverage broad development and manufacturing experience and leadership to support Kiniksa’s portfolio and vision.

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

Responsibilities (including, but not limited to)

• 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%.

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range

$359,000 — $390,000 USD

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We’ll ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.