Director, CMC, Drug Product

Xenon Pharmaceuticals • Needham, MA

2d • Hybrid

About The Position

We are seeking a Director, CMC, Drug Product to join our team. The Director, CMC, Drug Product manages and oversees the late phase process development, validation and commercial manufacturing of cGMP drug products for deployment in late-stage clinical trials and commercial distribution. The Director, CMC, Drug Product will be a key member of a highly collaborative internal CMC team, primarily managing drug product process validation, launch and commercial manufacturing through CDMOs and CROs.
This position reports to the Executive Director, CMC, Drug Product and will be based out of our Boston, MA, USA in our Needham office or in our Burnaby, BC, Canada office. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position; hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week. The level of the position will be commensurate with the candidate’s education and industry experience.

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).
• 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.

Nice To Haves

• Experience in developing formulations of small molecule solid oral and parenteral dosage forms is a plus.

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.

Benefits

• Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
• Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown.
• Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees