Job Description
Qualifications
Associate's degree in a relevant scientific or engineering discipline
Knowledge and understanding of pharmaceutical manufacturing terminology and cGMP quality requirements
2 years' experience in the pharmaceutical industry or relevant experience in another FDA regulated industry
Must possess assay trouble shooting experience in their area of expertise or area relevant to industry
Basic computer skills required, including command of Microsoft Office programs (Excel, Word, Outlook)
Must be able to lift 30 lbs
Must be able to work from a standing position for prolonged time periods
Regular stooping, bending, or crouching
Frequent communication hearing/speaking/writing in English
Must be able to perform repetitive motion tasks
Must be comfortable, willing, and able to work with automated equipment and machinery
Benefits
Salary Range: $60k-$75k/yr
Responsibilities
FULL DESCRIPTION: Under direct supervision of the Supervisor of Production Services, this individual will be responsible for day-to-day activities in in support of manufacturing
Theses duties include, but are not limited to diluent buffer preparation, final drug product formulation, component washing and sterilization for upstream and downstream activities, facility sanitization oversight, management of critical manufacturing inventory including cleanroom garments
The selected candidate will be responsible for:
Drug product/buffer formulation activities including diluent preparation
Execution of specifically assigned projects, to include ordering supplies, and communication of project status to senior management
Provide production summary to management
Participate in technical transfer and implementation of buffer preparation strategies
Perform preparation of diluent formulation, filtration systems, cleanroom organization and sanitization
Execute SOPs, master batch records, and other cGMP documentation
Propose implementation of production procedures to optimize manufacturing processes
Monitor processes and results and suggest methods to ensure process success
Adhere to quality standards set by regulations and in accordance with current NBS policies and procedures
Familiar with equipment in a sterile drug manufacturing, including but not limited to: steam sterilizers, depyrogenation ovens, filling equipment, other manufacturing
Familiar with aseptic technique and cleanroom behavioral concepts
Perform other duties as assigned
Job description
Manufacturing Associate - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Manufacturing Associate with a medical device company in San Diego, CA who possesses:
• At least a high school diploma, Degree in Life Science is preferred
• 2-5 years in a manufacturing aseptic, cleanroom environment
• Autoclaves, batch dry heat oven, basic manufacturing equipment, centrifuges, incubators, bulk drug formulation, fill machine, isolators.
Email resumes to aaron@simplybiotech.com or call 858.427.3668.
FULL DESCRIPTION: Under direct supervision of the Supervisor of Production Services, this individual will be responsible for day-to-day activities in in support of manufacturing. Theses duties include, but are not limited to diluent buffer preparation, final drug product formulation, component washing and sterilization for upstream and downstream activities, facility sanitization oversight, management of critical manufacturing inventory including cleanroom garments.
The selected candidate will be responsible for:
• Drug product/buffer formulation activities including diluent preparation
• Execution of specifically assigned projects, to include ordering supplies, and communication of project status to senior management.
• Provide production summary to management
• Participate in technical transfer and implementation of buffer preparation strategies.
• Perform preparation of diluent formulation, filtration systems, cleanroom organization and sanitization
• Execute SOPs, master batch records, and other cGMP documentation
• Propose implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success
• Adhere to quality standards set by regulations and in accordance with current NBS policies and procedures
• Familiar with equipment in a sterile drug manufacturing, including but not limited to: steam sterilizers, depyrogenation ovens, filling equipment, other manufacturing
• Familiar with aseptic technique and cleanroom behavioral concepts.
• Perform other duties as assigned
The selected candidate will also possess:
• Associate's degree in a relevant scientific or engineering discipline.
• Knowledge and understanding of pharmaceutical manufacturing terminology and cGMP quality requirements.
• 2 years' experience in the pharmaceutical industry or relevant experience in another FDA regulated industry.
• Must possess assay trouble shooting experience in their area of expertise or area relevant to industry.
• Basic computer skills required, including command of Microsoft Office programs (Excel, Word, Outlook)
• Must be able to lift 30 lbs.
• Must be able to work from a standing position for prolonged time periods.
• Regular stooping, bending, or crouching.
• Frequent communication hearing/speaking/writing in English.
• Must be able to perform repetitive motion tasks.
• Must be comfortable, willing, and able to work with automated equipment and machinery.
Salary Range: $60k-$75k/yr
For immediate and confidential consideration, please email your resume to aaron@simplybiotech.com or call 858.427.3668. More information can be found at www.simplybiotech.com
