Overview
Skills
Job Details
Please note that this is a 6-18 months contract position.
Required Qualifications:
Experience with CGMPs
Experience with pharmaceutical/biopharmaceutical manufacturing is required, especially for a temporary position, as it would be challenging to get someone up to speed on regulatory expectations for pharmaceutical processes in the limited time projected for the role.
Key terms to look for in resumes include Technical Services (TS) or Manufacturing Science and Technology (MSAT or MS&T), as these are direct analogues to the current role.
Experience with document generation, including:
Change control (CC)
Corrective action and preventive action (CAPA)
Batch record (BR or MBR)The primary focus for this position will be writing and/or reviewing the various documents listed above.
Job Description:
The day-to-day responsibilities for this role may vary, but it will primarily include:
Writing and reviewing batch records for GMP oligonucleotide pharmaceutical manufacturing
Writing and reviewing change controls for these processes
Collecting and evaluating manufacturing batch data
Applicants must provide their phone number. Reference job number A4479.