Head – Global External Manufacturing
Confirmed live in the last 24 hours
Amylyx Pharmaceuticals

201-500 employees

Develops treatments for progressive neurodegenerative diseases
Company Overview
Amylyx Pharmaceuticals stands out as a global leader in the development of treatments for neurodegenerative diseases, demonstrating a strong commitment to its mission through collaborative work and community support. The company's culture is deeply rooted in empathy and dedication, focusing on creating more moments for those living with these relentless diseases. Their competitive edge lies in their patient-centered approach, which drives their technical innovation and industry leadership.
Biotechnology

Company Stage

N/A

Total Funding

$553.9M

Founded

2013

Headquarters

, Massachusetts

Growth & Insights
Headcount

6 month growth

11%

1 year growth

39%

2 year growth

138%
Locations
Cambridge, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Management
CategoriesNew
Operations & Logistics
Requirements
  • 15+ years of outsourced clinical and commercial manufacturing and supply chain management experience in the biotech/pharmaceutical industry
  • Bachelor's degree
  • Experience in managing outsourced manufacturing and supply chain
  • Track record of developing, negotiating, and administering clinical and/or commercial contract manufacturing agreements
  • Strong knowledge and experience in designing and implementing outsourced manufacturing and supply chain best practices
  • Deep familiarity in phase-appropriate cGMP quality systems with good understanding of regulatory requirements
  • Firsthand experience in authoring and reviewing regulatory documents and participation in regulatory audits from agencies like FDA, EMA, PMDA, etc
  • Experience with manufacturing technical support or manufacturing sciences and technical support organization is desirable
  • Experience in handling and leading investigations, deviations, and quality events. Participation is CAPA, developing CAPA plans, audit reports, annual reports, validation plans, protocols, assessments, technical memo and other regulatory and quality documents etc
  • Experience and comfort level with operating in early-stage pharma/biotech environment
  • Intercultural experience and ability to operate and adapt in a complex and rapidly changing business environment
  • Impeccable problem solving and collaboration skills with quality-driven mindset
  • Proven ability to facilitate conversations and drive towards decisions. Ability to influence
  • Proven ability to lead teams and develop individuals
Responsibilities
  • Lead the CDMO selection process in collaboration with internal stakeholders, including developing and negotiating development, technology transfer, and manufacturing/supply contracts
  • Manage the existing CMO/CDMOs and Packaging partners
  • Establish governance structures (joint project teams, steering committee) that facilitate timely, open communication with CDMOs and internal stakeholders, and successful delivery of CDMO services
  • Oversee and lead interactions with external manufacturing partners to assure on-time quality supply which meets compliance and regulatory requirements
  • Assist in alliance development and management as needed
  • Establish and manage the necessary manufacturing agreements including MSA’s (Master Services Agreements)
  • In partnership with the Quality organization, manage and ensure the timely review and release of product from external manufacturing partners
  • In partnership with the Regulatory function, manage the process improvements, continuous monitoring and validation and implement and product life cycle management changes per established time commitments
  • In partnership with Commercial function, manage the demand and supply
  • Author and/or approve technical reports, manufacturing instructions, process validation documents, regulatory submissions and other technical and management documents as needed
  • Manage overall External Manufacturing and Supply Chain budget and spending, carefully balancing risk and cost
  • Provide leadership for commercial & clinical supply continuity and risk management processes, including ownership of supply chain plans, inventory and forecasts used to support Amylyx programs
  • Lead the evaluation of Supply Chain redundancy efforts and programs continuously evaluating the risk of supply partners and operations making necessary recommendations and implementation plans to reduce potential interruptions to supply operations
  • Hire, lead, and develop employees to successfully meet group objectives
Desired Qualifications
  • Experience in handling and leading investigations, deviations, and quality events. Participation is CAPA, developing CAPA plans, audit reports, annual reports, validation plans, protocols, assessments, technical memo and other regulatory and quality documents etc
  • Experience with manufacturing technical support or manufacturing sciences and technical support organization is desirable