Director for CMC Adjuvant, CMC Operations

at  TSP A Syneos Health Company

PREFERRED EDUCATION

• Minimal: Master’s degree in Organic Chemistry.

PREFERRED EXPERIENCE

• Minimum 8 years’ experience in process development and CMC operations.
• Strong technical experience with lipopolysaccharide, peptide, or nucleotide solution phase synthesis, scale up and cGMP production is required.
• Experience in oil-in-water adjuvant production is desired.
• Late-stage CMC experience is strongly preferred.
• Strong understanding of the regulation requirements from the FDA and other regulatory agencies.

KNOWLEDGE, SKILLS, AND ABILITIES

• Willing to perform a wide range of duties in a smaller organization on an independent level and as a team player
• Excellent oral and written communication skills; ability to communicate effectively with co-workers and Health Authorities
• Proficiency in MS Office [Excel, Word, PowerPoint, MS Project], JMP statistical software and Adobe Acrobat
• Ability to travel as required by projects (10-25% of time, US and International)
• Ability to work flexible hours for collaboration with international CDMOs/partners

EQUAL OPPORTUNITY EMPLOYER/PROTECTED VETERANS/INDIVIDUALS WITH DISABILITIES

Curevo is proud to be an equal opportunity employer and does not discriminate based on race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.

PURPOSE

• Drive the adjuvant at CDMOs for development and scale-up, cGMP manufacturing, process characterization, and process validation for Phase 3 clinical studies and commercial supply.
• Contribute to regulatory filing and creation of policies and procedures to ensure compliance with the US Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211) as well as other regions (including EU, Asian).

KEY ROLES AND RESPONSIBILITIES

• Act as SME and lead the technical team at CMDO for late-phase adjuvant production (both lipopolysaccharide synthesis and oil-in-water adjuvant formulation), including tech transfer, scale-up, gap/risk analysis, process characterization/validation, cGMP manufacturing.
• Provide technical guidance and keep the project on time and in compliance with cGMP regulations.
• Review and approve controlled documents including batch records, SOPs, protocols, and reports related to process development and characterization.
• Work closely with QA/QC to identify and evaluate deviations, CAPA, and change control.
• Lead and direct the work of our partner organizations and consultants. Build strong communications and relationships with partner organizations and consultants.
• Ensure compliance with both internal Curevo process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
• Collaborate with CDMO for health authority inspection.
• Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
• Actively participate as a member of Curevo supporting product and new business development
• Participate in US and International specific documentation supporting the development and maintenance of products and ensuring filings meet local regulatory requirements.
• Adhere to all company policies, procedures, and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.