Vice President, CMC Strategy

Job not on LinkedIn

🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $303k - $341k / year

⏰ Full Time

🔴 Lead

👔 Vice President

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 22 days.

Apply Now

Find Similar Remote Jobs

Amylyx Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🏥 Healthcare

💼 Consulting

🛡️ Insurance

Healthcare • Consulting • Insurance

Amylyx Pharmaceuticals is a company dedicated to discovering and developing innovative treatments for diseases with high unmet needs. They focus on conditions such as Amyotrophic Lateral Sclerosis (ALS), Post-Bariatric Hypoglycemia (PBH), Wolfram Syndrome, and Progressive Supranuclear Palsy (PSP). Amylyx is committed to supporting patients and their loved ones, creating more moments of significance for them. They have recently acquired a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation and have shown positive results in clinical trials for Wolfram syndrome. The company emphasizes transparency, setting realistic expectations, and collaborating to make impactful changes in the treatment of neurodegenerative diseases.

📋 Description

• Lead integrated Chemistry, Manufacturing, and Controls (CMC) strategy, global execution, and lifecycle management across Amylyx’s preclinical, clinical, and commercial portfolio • Align CMC priorities with development plans, global regulatory requirements, commercialization readiness, and long-term product strategies • Lead the CMC asset leadership and program management organization • Develop portfolio-level priorities, resource allocation strategies, and risk mitigation plans • Oversee CMC activities from early development through regulatory approval, commercialization, and lifecycle management • Provide strategic oversight of CMC components of INDs, NDAs, MAAs, and other global regulatory submissions • Drive global CMC readiness and coordinate regulatory changes, commitments, and implementation activities • Develop and oversee CMC lifecycle management strategies, including manufacturing changes, site transfers, capacity expansion, and regulatory variations • Lead, mentor, and develop the CMC organization and build organizational capabilities • Establish CMC governance, program oversight, risk management, and performance management processes • Oversee CMC program timelines, budget assumptions, critical milestones, and risk escalation • Partner with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, Supply Chain, R&D, Clinical Development, Program Management, and Commercial teams • Represent CMC in senior leadership discussions and provide recommendations on strategic priorities, risks, investments, and business decisions • Drive continuous improvement and cross-functional alignment across CMC functions

🎯 Requirements

• Advanced degree in chemistry, chemical engineering, pharmaceutical sciences, or related scientific discipline • At least 15 years of progressive experience in pharmaceutical or biotechnology CMC • Significant leadership experience overseeing complex development programs and global CMC activities across the full product lifecycle • Experience leading CMC organizations, developing organizational capabilities, and managing high-performing teams • Extensive experience developing and executing global CMC strategies across preclinical, clinical, and commercial-stage programs • Proven track record leading successful global regulatory submissions, product approvals, and commercial readiness activities • Strong understanding of FDA, EMA, PMDA, ICH, and applicable cGMP standards • Expertise in CMC lifecycle management, including post-approval changes, global market expansion, comparability strategy, and regulatory commitments • Strong understanding of pharmaceutical development and manufacturing; experience in both large and small molecules preferred • Experience leading complex cross-functional programs and partnering with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, and Supply Chain • Strong business acumen • Ability to establish priorities, manage competing demands, anticipate risks, and drive execution across multiple programs • Exceptional leadership, communication, influencing, and collaboration skills • Ability to operate effectively in a dynamic, growing biotechnology organization • Ability to travel internationally up to 10%

🏖️ Benefits

• Annual performance-based bonuses • Equity awards • Comprehensive benefits package supporting health, well-being, and financial security • Remote work opportunities within the United States • Company-related events • Travel to company events and corporate location • Equal opportunity employment • Accommodations available for candidates who require them in the selection process

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume