Cambridge, MA, United States
6++ month contractual role with high possibility of long term extension or Permanent conversion; Must have experience in Commerciaized Drug Product manufacturing.
**MEMBERS ONLY**SIGN UP NOW***. is seeking an experienced Engineer to fill an 6+++ month contractual role, with high possibility of long term extension or Permanent conversion, with a large global pharmaceutical company in Cambridge, MA.. Must have knowledge on working with contract manufacturing sites, sterile parenteral manufacturing, lyophilization, manufacturing process design, and validation.
REQUIREMENTS of the Commercial Drug Manufacturing Engineer
BS degree in chemical engineering or a closely related field and possess 1 - 5 years experience in commercialized drug products
* Knowledge on working with contract manufacturing sites, sterile parenteral manufacturing, lyophilization, manufacturing process design, and validation.
* Have familiarity with manufacturing facilities, unit operations, process control, modern analytical methodologies and instrumentation
OBJECTIVES of the
Commercial Drug Manufacturing Engineer
Assist staff within the Technical Operations, Drug product group with support in commercial manufacturing of drug dosage forms, drug product manufacturing process design, optimization, scale-up, technology transfer and validation.
ACCOUNTABILITIES of the Commercial Drug Manufacturing Engineer
Assist day-to-day technical support for commercial drug product manufacturing –i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.
Assist with Technical Operations’ senior staff in the management of CMO manufacturing activities – act as a technical liaison between Technical Operations and third-party drug product manufacturers to effectively manage drug product manufacturing
Coordinate among various Pharmaceutical Operations groups (Supply Ops, QA, QC) in compiling and analyzing production data, such as IPC, release, and manufacturing process information.
Assist in the authoring of pertinent SOP’s and manufacturing process instructions.
Manage Change Controls, investigations, and provide technical support for CAPAs.
Job Types: Full-time, Contract
manufacturing process design: 1 year (Required)
sterile parenteral manufacturing: 1 year (Required)
Commercial Drug Products: 1 year (Required)
lyophilization: 1 year (Required)
7 - 11 months
Full Time Opportunity:
Monday to Friday