Kiniksa Pharmaceuticals

Biopharmaceutical therapies for debilitating diseases

Group Vice President of Manufacturing

Bioprocess & BiomanufacturingPosted on Nov 13

Full-timeLexington, MA, USA$359k - $390k

About the Job

Requirements

A PhD in Pharmaceutical Sciences, Biology, Biochemistry, Chemical/Biochemical Engineering, or a related field is required.
Extensive experience (15+ years) in the biotech pharmaceutical industry, including expertise in development and manufacturing and progression of programs through clinical development and commercialization, is required.
At least 10 years of leadership experience with a demonstrated record of success is required.
Strong technical and scientific experience in product development and commercialization is required.
Extensive experience with regulations and requirements such as current Good Manufacturing Practices (cGMP), International Council for Harmonisation (ICH), United States Pharmacopeia (USP), Japanese Pharmacopoeia (JP), and global Chemistry, Manufacturing, and Controls (CMC) regulatory expectations, as well as a proven track record of resolving complex issues with health authorities, is required.
Strong knowledge of phase-appropriate regulatory requirements for biologics development is required.
Experience authoring regulatory filings and interacting directly with health authorities is required.
Experience in contract development and manufacturing organization (CDMO) and vendor evaluation, selection, and management is required.
The candidate must be able to understand technical, regulatory, and business implications, as well as complex cross-functional considerations, when establishing development plans.
The candidate must be able to balance near-term objectives with long-term goals, scenario plan, evaluate risks and benefits, and develop effective solutions.
The candidate must be able to manage multiple priorities and work with ambiguity to deliver results.
The candidate must be able to travel up to 5%.

Responsibilities

Lead and manage internal and external drug substance (DS), drug product (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 to ensure 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.
Attract, retain, and develop talent to maintain a high-performing team with an innovative and agile mindset.
Support budget forecasting and manage budgets and resources.
Develop effective and efficient working relationships with internal and external partners.
Collaborate with Regulatory Affairs on regulatory strategy and author and review regulatory submissions and correspondence as needed.
Work with a diverse cross-functional group of partners to ensure program deliverables and timelines, and lead the 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 key performance indicators, and vendor performance management, including joint steering committee 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 emerging technologies related to development and manufacturing.
Support and lead innovative opportunities, such as evaluating artificial intelligence to improve development efficiencies and assessing facility expansion, as needed.
Support due diligence projects.

Desired Qualifications

Experience with protein therapeutics development is preferred. Experience with multiple therapeutic modalities is a plus.

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 will 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.

Pay Range 359000 - 390000 USD

About the Company

Kiniksa Pharmaceuticals

Biopharmaceutical therapies for debilitating diseases

Kiniksa Pharmaceuticals develops and delivers therapies for patients with serious diseases that have few good treatment options. The company focuses on research and development, conducts clinical trials, and then brings approved therapies to market. Its products are created through an R&D process and are intended to be used by patients via the healthcare system, with outcomes measured to help save or improve lives. What sets Kiniksa apart is its patient-centric approach and commitment to urgency and integrity, along with a business model that combines internal R&D with partnerships and licensing to bring therapies to patients. The company aims to improve patient outcomes and quality of life by delivering effective treatments where options are limited.

Company size: 201-500
Company stage: IPO
Headquarters: Lexington, KY
Founded: 2015

Recently Posted Jobs

Explore more opportunities at Kiniksa Pharmaceuticals

See more jobs