CMC Director

Enveda

2d•$210,000 - $220,000•Remote

About The Position

At Enveda, every role drives impact. As a CMC Director, you will play an important role in the execution of Envedaâs chemical and pharmaceutical development and manufacturing deliverables with a focus on early-phase work (development candidate nomination through Phase 2b). Your expertise will guide the CMC-related activities spanning process development, manufacturing, and regulatory submissions. As a key member of the CMC team and reporting to the Sr. Director, CMC Process R&D, your contributions will be instrumental in the execution of our aggressive chemical and pharmaceutical development and manufacturing strategies and ensuring the delivery of high-quality products.

Requirements

A Ph.D. holder with specialization in synthetic organic chemistry.
A minimum of 6 years of experience in pharmaceutical CMC development. This can be exclusively work at the bench or project management in a Big Pharma setting; work in a biotech setting managing external R & D; or a mixture thereof.
Experienced in chemical development, manufacturing and tech-transfer with a solid understanding of industry guidance and regulations.
Experienced in the management and oversight of development and manufacturing projects conducted at external CDMOs.
Experienced in the preparation and review of CMC regulatory documents
Demonstrated ability to independently solve diverse chemical, technical, and logistical problems.
Good communicators capable of conveying complex scientific data, both orally and in writing, to a broad audience, including non-specialists and regulatory bodies.
Experienced in managing CMC budgets at the project level.

Responsibilities

The development and oversight of the budget for your projects, emphasizing cost-effectiveness without compromising quality
Ensuring regulatory compliance and seamless implementation of industry guidance (ICH, USP, etc.) and cGMP regulations, aided by Envedaâs Quality Assurance team
The process design, troubleshooting, scale-up, and tech transfer for drug substance and drug product manufacturing, collaborating with both external contract development and manufacturing organizations (CDMOs) and internal development project teams to deliver drug substance and clinical drug product according to established timelines
Ensure strict adherence to global regulatory guidelines throughout the manufacturing, packaging and testing processes.
Serving as the CMC lead and point of contact for assigned projects on internal multidisciplinary project teams
Serving as a CMC point of contact during discussions with health authorities worldwide, as needed
Lead the preparation and critical review of CMC regulatory documents for IND, QOS, IMPD, and various other regulatory submissions, as needed
Review various classes of manufacturing-related documents such as (but not limited to): CoAs; manufacturing batch records; change controls; stability protocols and reports; various development study protocols and reports; specification documents; etc.
Overseeing drug substance supply for non-clinical toxicology studies
Overseeing drug substance and drug product supply for clinical studies.