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 against cancer.
Our client is moving toward multiple products in numerous early phase clinical programs. The CMC Project Manager will work with the CMC group and manage activities at multiple CDMOs 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.
- Maintain and ensure availability of CMC documentation necessary for regulatory filings or health authority interactions.
- Develop CMC project budget plans and communicate plans and updates with the finance team.
- Review/approve invoices and monitor project costs to maintain the CMC budget.
- Engage regularly with the Clinical Operations group to ensure continuity of material availability for use in on-going clinical trials.
- Develop project plans incorporating R&D, pre-clinical, CMC, regulatory and clinical activities to support timeline and resource planning.
- Interact with the business development staff as necessary to support grant funding applications and any other BD activities.
- Facilitate successful team meetings by ensuring meetings are agenda driven, that accurate meeting records are documented and maintained and that timely action item follow-up occurs.
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 CRO/CDMO interface, work experience and/or 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.