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GMP Downstream Specialist

The role of the GMP Specialist – Downstream is to manufacture various scale products in accordance to the current Good Manufacturing Practices (cGMP).

The main responsibilities will include but not limited to follows:

• Perform purification of proteins using various column chromatography.
• Perform column packing and qualifications of various resins.
• Operate and maintain production equipment, such as AKTA Purifier, AKTA Pilot, and AKTA Process according to the SOPs in place.
• Perform UF/DF, and various filtration methods.
• Assemble and operate Millistak Pod holders, and Millipore Cassettes holders.
• Perform Aseptic technique in Biological Safety cabinets and Laminar Air Flow.
• Perform integrity testing on various types of filters.
• Write batch records and SOPs for the downstream operations.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Purchase raw material/ production items as needed.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Occasional overtime and weekend work is required.
• Interacts with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects.
• Participate in technology transfer of processes from Process Development to Manufacturing.
• Work cross functional with the upstream manufacturing group to provide resources as needed.
• Perform tasks under minimal supervision, and within tight time lines to meet production schedules.
• Report any unexpected observations and suggest possible explanation and resolution.
Knowledge and Experience Required:

• Bachelor’s or Master’s Degree in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, Biology), with 3-5 years of experience in the GMP biomanufacturing industry.
• Experience with Downstream cGMP Manufacturing is required.
• Experience with operating the Unicron software is required.
• Intermediate computer skills using MS Office (Word, Excel, Power Point) preferred.
• Possess excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management and staff.
• Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task.

Additional Information:

Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that “negotiable” is neither salary nor requirements. Salary commensurate with experience.




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