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 PGxHealth 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.
Manager / Director, Manufacturing and CMC
Duties and Responsibilities
- Support of new drug formulation development, manufacturing scale up process, preclinical and clinical development.
- Development and execution of stability, validation and analytical method transfer protocols.
- Support of lead optimization process and preclinical 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 develoment programs
Background Requirements
- Education, Experience, and Knowledge
- A minimum of a Bachelor's degree (B. A.) preferably in organic or analytical chemistry, biochemistry or pharmacy from four-year college or university.
- Preference for applicants with advanced degrees or training.
- 5+ years experience in research and development or in a regulatory role
- Skills and Abilities
- Firm knowledge of applicable regulations for submitting CMC content for INDs and NDAs and/ or BLAs
- Experience in maintaining CMC sections and in assuring the related regulatory compliance of ongoing manufacturing and testing.
- Capable to participate in and/or lead multi-disciplinary teams to the successful and timely closure of CMC submission goals
- Hands-on experience with assuring GMP compliance in a development and / or commercial laboratory and manufacturing environment
- Experience in managing relationships with contract manufacturers and test laboratories
- Excellent communication skills (oral and written)
NOTE: This job profile describes the duties and requirements of the position. Requirements stated are representative of minimum levels of knowledge, skills and/or abilities required to successfully perform the job. The employee may be asked to perform other job-related duties as required.
To apply for this position, please visit https://home.eease.com/recruit/?id=369313
Please send resume to jobs@clda.com.
CLINICAL DATA IS AN EQUAL OPPORTUNITY EMPLOYER.
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