Associate II/III, Manufacturing (Purification)
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement.
Think what's possible.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
The incumbent is responsible for purifying approximately 25 commercial proteins in a regulated FDA licensed/ISO certified facility. Will coordinate all cross-functional activities associated with assigned production runs with downstream groups including Antigen Bulk Fill and QC testing and perform special projects as assigned such as development and validation activities.
Main areas of responsibility include:
Manufacture recombinant antigens to ensure commercial product demands are met:
- Order required raw materials, reagents, and starting material in preparation for assigned production runs.
- Assemble, complete, and review of run specific batch record packets.
- Perform SAP duties that include cycle counting, reservations, charges to process orders, and scrapping of expiring raw materials.
- Perform specific preventative maintenance related tasks as assigned by the area manager, including column testing procedures on an annual basis and those associated with ongoing validation studies.
- Deliver quality products and services on time to all customers, internal and external
Follow regulatory requirements:
- Perform all manufacturing operations under cGMP/ISO requirements. Follow valid manufacturing procedures and documentation.
Documentation:
- Maintain logbooks, inventory forms, revise SOPs, maintain in-process data spreadsheets, OJT and other records as required.
- Handle change control requests.
- Participate in Deviation Report investigations.
Analytical Testing:
- Responsible for analyzing in-process samples generated from protein purification processes. Complete all required documentation for proper traceability of a production lot.
- Operate a variety of basic lab equipment (pH meters, balances, centrifuges, and spectrophotometers) as well as more sophisticated equipment such as computers, HPLC systems, and densitometers.
Education (minimum/desirable):
BA/BS in the sciences (Biology, Chemistry, or related field)
Experience/Professional requirement:
- 3 to 5 years of experience in a GMP environment
- Must have knowledge of process and equipment validation
- Experience writing SOPs
- Experience with preparation of reagents following manufacturing instructions
- Strong attention to detail, able to document work accurately, excellent time management and organizational skills
- Experience in project management
- Monitor processes and products to identify opportunities for continuous improvement
- Previous experience / knowledgeable of SAP
