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Job Description
Job Description:
Provide technical support for the manufacturing process, including implementation of commercial manufacturing production programs and technical transfer of processes. Work on day and night shifts.
Responsibilities:
- Liaise with process science/technology transfer teams on manufacturing process transfer and startup.
- Provide technical input for manufacturing records, batch sheets, and procedures.
- Write and review Standard Operating Procedures and controlled documents.
- Resolves process problems on and off production suites.
- Collaborate with cross-functional groups to resolve process issues and improvements.
- Support manufacturing personnel in increasing technical knowledge of critical process steps.
- Support RFT programs on the floor.
- Modify process method files through the quality system.
- Implement CAPA on process-related improvements.
- Support downstream manufacturing process according to approved protocols, regulations, and schedules.
- Investigate process variances and communicate changes to supervisors.
- Interact with facilities, process development, engineering, and other departments.
- Work to the highest safety standards and represent manufacturing during regulatory and client audits.
- Implement continuous improvement initiatives.
Requirements:
- Knowledge and experience of Downstream Process.
- Logical troubleshooting and problem-solving skills.
- Excellent analytical, written, and oral communication skills.
- Ability to work within a successful team.
Qualifications:
- BS/BA/BEng in Life Sciences or related field.
- 2+ years of relevant cGMP Manufacturing/Engineering/Scientific experience in a Drug Substance Biotech facility.
Please note that certain background checks will form part of the recruitment process.