GeneCoda® has been engaged to identify and evaluate candidates, for a CMC Project Manager to be located in the RTP, NC marketplace.
About Our Client:
Our client is an immuno-oncology company developing novel therapies that activate a patient’s immune system to fight cancer.
Our client is filing several IND’s to advance multiple products into early phase clinical programs within the next year prompting the recruitment of this opportunity. The CMC Project Manager will work with the CMC group and manage activities at multiple CMO's and analytical contract laboratories to ensure product development project goals and milestones are achieved.
- Interact and communicate with contract manufacturing and analytical laboratory organizations to coordinate process development, assay development and preclinical development programs and activities for CMC development programs.
- Maintain detailed status updates to support multiple CMC product development projects.
- Communicate project status updates and actions required to internal team members clearly and accurately.
- Identify issues affecting project timelines and ensure management awareness to facilitate decision-making to mitigate such issues.
- Monitor project costs to maintain budget for the CMC group.
- Assist Clinical Operations group as necessary to ensure continuity of material availability for use in supporting ongoing clinical trials.
- Maintain and ensure availability of CMC documentation necessary for regulatory filings or health authority interactions.
Bachelor of Science degree in chemistry, biology or related field. PMP certification preferred.
- 5+ years of experience in the pharmaceutical/biotech clinical research industry; with at least 3 years of relevant CMC Project Management work experience.
- Prior CMO/CDMO interface and management experience.
- Biologics industry experience preferred.
- Working knowledge of GMP and GLP manufacturing and laboratory environments/requirements and familiarity with clinical trial packaging/labeling and distribution.
- Passion for problem solving and teamwork.
- Strong collaborative skills, team player mentality.
- Effective decision-making and problem-solving
- Strong organizational skills.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written English communication skills.
- Willingness to travel up to 10% of the time as work requires.
GeneCoda® refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state or local law.