GRA CMC Specialist
Alpha Home Health and Hospice · Bridgeport, PA · 1 mo ago
On-siteOTHRFull-time
About the role
Responsible for supporting Chemistry, Manufacturing & Controls (CMC) activities related to biologics and gene therapy programs.
Responsibilities
- Compile and review CMC data from analytical, process, and formulation development teams.
- Translate CMC findings into high-quality regulatory documents for IND, IMPD, and BLA submissions and responses.
- Coordinate with Regulatory Affairs, QA, and Manufacturing to ensure compliance with global guidelines.
- Maintain robust documentation and ensure data integrity across projects.
- Assist in managing timelines and mitigate risks within a collaborative, patient-focused environment.
Qualifications & Skills
- Strong understanding of CMC development processes for biologics and gene therapies.
- Experience in preparing regulatory documentation and submissions.
- Excellent collaboration skills with cross-functional teams.
- Attention to detail and commitment to data integrity and compliance.