*** If interested and fully qualified, please reply with updated resume, cover letter, salary requirements and availability for at least a phone interview over the next 5 business days.
Reply to: pierre@recruitingprofessionals.biz
Job Title: Manufacturing Manager (NEW position)
Base Salary: $125,000 to $185,000 plus Bonus
Plus Relocation Assistance provided
Location: New Haven, Connecticut (CT)
At least 5 to 7 Years Experience
JOB DESCRIPTION
The Manager/Director of Manufacturing and CMC has primary management responsibility for overseeing the development efforts regarding API, drug product production, and the CMC regulatory issues necessary to enable the Research groups mission of developing new therapeutics and transitioning its development stage compounds into clinical development.
This person is also a key scientific advisor of the drug discovery team across the company's research comprised of pharmacology, chemistry, toxicology, clinical development and regulatory group leaders. This person will coordinate activities at external laboratories and manufacturers and work closely with the company's internal scientific team.
ESSENTIAL FUNCTIONS AND DUTIES
* Support of new drug formulation development, manufacturing scale up process, pre-clinical and clinical development.
* Development and execution of stability, validation and analytical method transfer protocols.
* Support of lead optimization process and pre-clinical development.
* Support of formulation development for new drug products.
* Characterization of reference standards.
* Development, optimization and validation of analytical methods.
* Participating in a filing process of an Investigational New Drug Application (IND) to the FDA.
* Member of company's Product Development Group which determines scientific strategy for the company's discovery and development programs
