Join the Clexio team

Responsibilities

• Overall responsibility for managing key activities across CMC disciplines, including formulation and analytical development, CMO selection and Tech transfer to CMO, clinical Trial material manufacturing and establishing CMC documentation for regulatory submissions.
• Formulation design/development.
• Writing and reviewing documents for INDs / regulatory section submissions.
• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents.
• Establish and manage integrated CMC timelines for formulation development, analytical development, clinical trial material manufacturing and release of clinical batches.
• Contribute to budget development and control for all CMC activities.

Skills & Qualifications

• PhD in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutical Science, or related scientific discipline- a must.
• At least 10 years’ relevant experience in development and manufacturing of oral dosage forms (e.g., tablets, capsules, etc.,) under pharmaceutical CMC/cGMP environment, for Phase 1 through Phase 3 clinical trials.
• Extensive knowledge of the manufacturing process, related equipment for oral dosage form products. In-depth, hands-on experience in formulation development of oral solid and liquid pharmaceutical dosage forms.
• Substantial experience in managing International CMOs for the manufacture of cGMP Drug Product.
• Experience with cGMP manufacturing ; IND, IMPD, CTA and NDA filings;
• Thorough Knowledge of relevant FDA and EMEA regulations.
• Excellent written and verbal communication skills in English.
• Exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).