Job Openings

SUMMARY:

Oversee and coordinate day-to-day activities of fermentation team along with support technicians/lab aides to ensure smooth operation of cGMP fermentation activities. Report any issues that might impact fermentation to the Manager of fermentation, to which this position reports. Provide training to fermentation staff on fermentation processes and SOPs/BRs for GMP production. Coordinate all GMP activities including hands-on GMP fermentation. Write and review batch records as required. Complete QA batch record review. Coordinate/schedule fermentation department activities with cross functional departments (QA, FE, QE, PP, etc.) to maintain cGMP compliance.  Responsible for meeting production schedules within stated time frames and within both quality and cost objectives.  Recommend new processes, equipment, etc., to make operation more efficient.  Prepare lead technician employee evaluations.

ESSENTIAL DUTIES:

§  Oversee and coordinate day-to-day activities of fermentation processes and fermentation staff in meeting the biopharmaceutical manufacturing in accordance with cGMP guidelines.

§  Responsible for the training and maintenance of training binders for fermentation staff.

§  Oversee and ensure the maintenance and performance of reactors and general upkeep of manufacturing fermentation GMP suites. 

§  Ensure all raw material needs and supplies are available and maintained by fermentation staff. 

§  Review and approve all LUMAC(s) related to Manufacturing fermentation 

§  Plan, coordinate and assist in the set-up of all the GMP fermentation activities and ensure suites and bio-reactors are functional for usage.

§  Review the executed Production Batch Records and submit for Manager’s approval 

§  Lead in the preparation and maintenance of cell bank inventory within the manufacturing fermentation department.

§  Coordinate all the routine maintenance and preventive maintenance activities with Facility Engineering and outside vendors.  Ensure the timely completion of work and in meeting our operational standards. 

§  Collaborate with Pilot Plant fermentation for training and transfer processes when needed. 

§  Work closely with Pilot Plant fermentation to troubleshoot manufacturing  processes.

§  Perform trouble-shooting of instruments and processes.

§  Perform technical training on the production floor and in a classroom setting.

§  Batch Production Record Review.

§  Execute in process/equipment validation protocols.

OTHER RESPONSIBILITIES:

§  Write technical development reports and, when necessary, give oral presentations of data at departmental or interdepartmental meetings.

§  May Contribute to scientific journal publications

§  Comply with XOMA’s Policies and Procedures

QUALIFICATIONS/REQUIREMENTS:

Education and/or experience

§  B. Eng in Biochemical Engineering/ Chemical Engineering, B.Sc./ M.Sc. in biology or related field with >8  years of relevant experience

§  Minimum 5 years experience supervising a fermentation operation in a pharmaceutical or regulated environment.

§  In depth experience in development and manufacturing of recombinant proteins by fermentation/ cell culture.

§  Knowledge of hardware and software used in fermentation processes at intermediate to commercial scale (130L-2750L).

§  Would possess comprehensive, hands-on experience with process equipments and ability to trouble shoot them.  

§  Should possess knowledge of cGMPs and process validation requirements.

Special skills/knowledge

§  Thorough knowledge of cGMPs and their application to pharmaceutical manufacturing.

§  Able to work independently and as part of a team.

§  Effective organizational and good record-keeping skills

§  Effective communication skills.

To apply for this job, please send us an e-mail with your resume and cover letter.