Sr. Director, Drug Product Development & Mfg

Role Summary

Senior Director of Drug Product Development & Manufacturing provides scientific, technical, and hands-on leadership to formulation development, drug product development, combination product development and manufacturing operations for pipeline programs from clinical through commercialization, with a strong focus on late-stage drug product development and process validation. This role is based in Lexington, MA with a hybrid schedule of 4 days in the office and 1 day remote.

Responsibilities

• Lead, manage, mentor and inspire the Drug Product team.
• Manage the Drug Product group budgets, including external costs and equipment.
• Establish overall drug product development and manufacturing strategies.
• Oversee formulation development, drug product development, combination product development and manufacturing activities supporting pipeline programs, including manufacturability assessment, formulation and dosage form development, development of efficient and scalable manufacturing processes, technology transfer and drug product process validation.
• Support commercial drug product manufacturing to ensure efficient production and delivery of material to inventory.
• Serve as drug product SME to support CMC and program teams in technical due diligence, CRO and CMO capability assessment, selection and management.
• Develop, author, review and approve technical memos, study protocols and reports. Review and approve related GMP and quality documents.
• Author and review relevant sections in regulatory submissions (IND, BLA, MAA, etc.), including responses to inquiries from Health Authorities.
• Provide scientific/technical guidance, leadership and decision-making across the company.
• Provide input and participate in long term strategic initiatives to enable and advance effectiveness and efficiencies in product development.
• Stay current with regulatory requirements, trends, and new emerging technologies as it relates to formulation development, drug product development, combination product development and manufacturing.

Qualifications

• Advanced degree in a scientific or engineering discipline: Ph.D. with 10+ years, MS with 15+ years, or BS with 18+ years of relevant experience, preferably in biotechnology or pharmaceutical industry.
• In-depth knowledge of protein chemistry, bioanalytical and biophysical techniques pertaining to protein stability and pharmaceutical development.
• Demonstrated technical expertise in formulation development, drug product development, process design and scale-up, and manufacturing of common parenteral drug product dosage forms.
• Demonstrated experience in leading late-stage drug product development, including PPQ strategy, process characterization and validation, tech transfer and BLA authoring.
• Knowledge and experiences in combination product development and production, such as pre-filled syringe, autoinjector and wearables, preferred.
• Experience with inhalation delivery systems is a plus.
• Significant experience in collaborating with CRO, CMO, drug product component suppliers and strategic development and production partners.
• Experienced with regulatory submission and working knowledge of industry practices and regulations (e.g., GxP, ISO, ICH, etc.) across multiple Health Authorities (e.g., FDA and EMA).
• Strong project management, interpersonal, communication, negotiation, and problem-solving skills.
• Proven ability to lead in a team environment to solve complex technical challenges.
• Ability to manage multiple priorities and work with ambiguity to deliver results.
• Leadership and managerial experience.
• Embodies Kiniksa values; high integrity and professionalism when interacting with outside investigators and vendors.
• Entrepreneurial and capable of thriving in a fast-paced, creative, resourceful small company environment.
• Ability to travel up to 10% (domestic and international).

Education

• Advanced degree as specified in Qualifications (Ph.D./MS/BS) in scientific or engineering discipline relevant to biotechnology or pharmaceutical development.