Lead late-stage Chemistry, Manufacturing, and Control (CMC) activities on global project teams including process optimization, process validation, clinical manufacturing, regulatory writing, and commercial readiness.
The initial project assignment will involve leading the product CMC program from Phase III, through to NDA, pre-approval inspection, and launch.
Identify and select CMC vendors based on project and budgetary needs. Define quality and performance specifications. Oversee vendor activities to assure product specifications, quality, safety and budgets meet necessary requirements. Ensure timelines meet corporate goals and work to assure projects stay on schedule.
In support of projects, identify and implement quality by design validation strategies.
Compilation of regulatory CMC documents for investigational and market approval regulatory filings primarily in the US and EU.
Support CMC center of excellence. Identify, develop, and manage resources to support ongoing project activities, as needed. Help build the organization on complementary skills.
Represent company in business, technical, and/or project meetings.
Actively participate in global project team meetings and specifically lead CMC activities.
Finalize commercial spray-dry, filling, and packaging manufacturing processes.
Develop validation strategy and oversee validation plans, validation protocols, execution of experiments, and final validation reports.
Develop pre-approval and commercialization plans.
Review and approve master batch records, executed batch records and other GMP manufacturing documents.
Develop experimental designs and oversee experimental protocols and final reports.
Work in close collaboration with QA to ensure quality system compliance.
Prepare budgets, timelines, metrics, and track performance.
Manage CMC vendors including vendor selection, negotiating contracts and work orders, vendor communication, and reviewing and approving invoices.
Write CMC documents in support of regulatory filings.
Prepare and deliver presentations to projects teams, vendors, clients, partners, and investors, as needed.
Late-stage pharmaceutical development experience with proven record in quality by design and process performance qualifications.
Pre-approval experience required with commercial experience preferred.
Small molecule, peptide, and protein development expertise preferred.
Combination drug device expertise desired with pulmonary drug delivery experience preferred.
PhD in pharmaceutics, chemistry, or related field strongly preferred.
Proficient in English both verbal and in writing.
Strong computer skills with ability to work in a paperless office.
Self-starter able to work with minimal direction.
High energy and passion for getting things done.
Ability to challenge the status quo and identify better ways to work and achieve goals.