Sr. GMP Specialist – Downstream
The role of the Sr. GMP Specialist – Downstream is to manufacture various scale products in accordance to the current Good Manufacturing Practices (cGMP).
The main responsibilities will include but are not limited to:
- Perform purification of proteins using various column chromatography methods with minimal to no supervision.
- Perform column packing and qualifications of various resins.
- Clear understanding of the Unicorn software used for Akta purification skid operation.
- Must be able to clearly understand and execute the methods programmed for column chromatography.
- 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.
- Write batch records and SOPs for the downstream operations.
- Review executed 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 to coordinate sample submission and receipt.
- Participate in technology transfer of processes from Process Development to Manufacturing.
- Work cross functional with the upstream manufacturing group to provide resources as needed.
- Report any unexpected observations and suggest possible explanation and resolution.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
- Bachelor’s or Master’s Degree in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, Biology), with minimum 4-5 years of experience in the GMP biomanufacturing industry.
- Minimum of 2 year specific Downstream cGMP Manufacturing experience is required.
- Experience with operating the Unicron software is required.
- Experience with writing/programming of Unicorn Methods is preferred.
- 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.
- Demonstrated ability to work as a strong contributor in a team environment and able to interaction with all echelons of management and staff.
- Must be detail-oriented, dependable, motivated, ability to work with minimal supervision; Proven multi-tasker able to handle multiple projects well;
- Strong/effective interpersonal skills, both communication and written & able to communicate effectively with all echelons of Management and staff.