Hybrid Director, CMC, Drug Product

at Xenon Pharmaceuticals Inc.

• Job title: Director, CMC, Drug Product
• Job type: Full Time
• Experience level: Lead
• Salary: $222,300 - $240,900 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Boston, United States

About the role

• Director managing late phase drug product development and manufacturing for a neuroscience biopharmaceutical company. Collaborates on commercial strategy and regulatory submissions.

Responsibilities

• Lead teams in late-stage process development and scale up, process validation (PPQ) and commercial manufacturing of small molecule drug products.
• Oversee late phase development and manufacturing processes, ensuring compliance with quality and regulatory standards.
• Manage development activities related to late-stage process development and scale up, FMEA analysis, process validation (PPQ) and preparation for commercial launch of small molecules drug products at partner CDMOs and CMO.
• Manage on-going commercial manufacturing and primary packaging of approved small molecule drug products by working with supply chain, quality and regulatory groups. Serve as CMC SME of commercial drug product supply.
• Manage the selection of late-stage and commercial CDMOs while considering capabilities, capacities, redundancy and quality.
• Provide input for drug product stability programs and help select appropriate packaging for clinical development and commercial use.
• Evaluate, recommend, and manage qualified CDMOs for manufacturing drug products for late-stage clinical trials, scale-up, registration, validation and commercial use. Collaborate with Quality Assurance to manage audits and inspections of CDMOs and on manufacturing investigations.
• Author and review core CMC documents/modules and other submissions and responses to FDA and other Competent Authorities, ensuring strategic oversight and consistency for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates.
• Stay informed on pharmaceutical development and manufacturing industry science, regulatory guidelines and competitive trends to provide informed recommendations.
• Develop and propose objectives in alignment with overall company strategies and plans.
• Collaborate with development and commercial partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies.
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some domestic and international travel will be required.
• Other duties as assigned.

Requirements

• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or a related discipline with at least 10 years of relevant management experience in a pharma or biotech environment. Candidates with an MSc and relevant experience may also be considered.
• Extensive experience in managing late-stage drug product manufacturing and commercialization activities (registration, process scale up, validation and launch), including oversight of external Contract Manufacturing Organizations (CMOs).
• Experience in developing formulations of small molecule solid oral and parenteral dosage forms is a plus.
• Strong background in drug product manufacturing sciences with experience with multiple solid oral manufacturing approaches such as capsules, tablets, spray drying, granulation, blending, bottling and blistering.
• Demonstrated success in transitioning development assets to commercial products and ongoing support of commercial manufacturing.
• Experience contributing to and developing CMC sections in US and ex-US regulatory filings.
• In-depth knowledge of cGMP regulations, guidance, principles, and best practices related to drug product development and manufacture.
• Proficiency in Failure Modes Effect Analysis (FMEA) and establishment of Critical Process Parameters (CPPs).
• Experience with CDMO selection, management, contracting, and issue resolution.
• Excellent oral and written communication, leadership, and interpersonal skills, with the ability to build credibility and trust both inside and outside the company.
• Proven ability to build and develop high-performing teams, with strong delegation and conflict resolution skills.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Short- and long-term disability
• Accidental death & dismemberment insurance
• Life insurance programs
• Employee Assistance Program
• Travel insurance
• Retirement savings programs with company matching contributions
• Vacation days
• Personal days
• Sick days
• Year-end company shutdown
• Training, Learning & Development program
• Tuition Assistance program for advanced degrees