CMC PROJECT MANAGER

a global biotech company is looking for CMC project manager

The CMC Project Manager has an 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 establish CMC documentation for regulatory submissions.

Formulation design/development.

Write and review 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.

Serve as departmental point of contact for securing internal review and approvals.

Contribute to budget development and control for all CMC activities.

Assist in finding innovative solutions to problems.

Qualifications:

" PhD Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutical Science, or related scientific discipline.

" 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 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.

" Experienced 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).