Manufacturing Specialist

Manufacturing Specialist at BioPhase Manufacturing Specialist at BioPhase in Poway, California Posted in about 22 hours ago.

Type:

full-time

Job Description:

LOCAL CANDIDATES ONLY PLEASE!

SUMMARY Under general supervision, the Senior Manufacturing Associate, Downstream, will perform routine manufacturing activities in GMP manufacturing areas including purification and the associated sub-processes/ preparation. Operations will be performed according to Standard Operating Procedures (SOPs) and batch records. Perform manufacturing steps, execute routine batch records, and revise documents such as batch records and SOPs as needed. Drives projects and assignments and provides mentorship to associates. Flexible shift schedule and overtime may be required.

JOB RESPONSIBILITIES

Technical:

Perform moderately complex tasks using defined protocols or procedures which contribute to the achievement of project milestones. Perform GMP manufacturing activities in assigned areas. Set-up, operate, maintain and clean downstream bioprocessing equipment, which includes but is not limited to chromatography systems, UF/DF and Viral filtration skids and mixers. Perform basic troubleshooting of bioprocess equipment. Perform manual cleaning and sterilization of manufacturing areas, parts and components.

Compliance:

Follow Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), plant safety guidelines and other established procedures during the manufacturing process to produce quality products. Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the manufacturing Good Documentation Practices (GDP). Draft and revise SOPs and batch records.

Teamwork and Communication:

Participate in regularly scheduled team meetings to discuss ideas, troubleshoot issues, go over lessons learned and identify future projects or tasks. May provide mentoring and coaching to colleagues, team members, or those with similar or less experience Act as Lead when Specialist/Supervisor is unavailable. Address production issues and report any compliance related concerns to supervisor and/or management as soon as possible. Fosters teamwork and is expected to suggest project improvements.

JOB REQUIREMENTS

Bachelor's degree with 6 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience. High School Diploma/GED with 8 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.