Within this role, you will be responsible for providing technical support on the manufacturing process. You will be a key member in the implementation of a large-scale commercial manufacturing production program and heavily involved in the technical transfer of processes.
This is a shift position, including day and night shifts.
As a Process Specialist Downstream, a typical day might include, but is not limited to, the following:
* Liaising with the process science/technology transfer teams in relation to the transfer and startup of the downstream manufacturing process.
* Being the key person for technical input into manufacturing records, batch sheets, and procedures.
* Writing and reviewing Standard Operating Procedures or other controlled documents as needed.
* Providing technical input to resolve process problems both on and off the production suites.
* Working closely with other cross-functional groups such as Maintenance, Process Sciences, and Engineering to resolve process issues and improvements.
* Supporting manufacturing personnel to increase technical knowledge of critical process steps on the floor.
* Supporting manufacturing personnel in implementing improvements to the process or work systems in the suites.
* Supporting RFT programs on the floor.
* Being responsible for modifying process method files through the quality system.
* Supporting CAPA implementation on process-related improvements.
* Supporting all aspects of the downstream manufacturing process according to approved protocols, regulation, and schedule.
* Being involved in supporting investigations into process variances according to site procedures.
* Communicating well with supervisors regarding changes to the process or material used within the process.
* Interfacing with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance, and Quality Control.
* Working to the highest safety standards, supporting safety improvements which require technical input.
* Representing manufacturing during regulatory and client audits.
* Implementing continuous improvement initiatives.
This role might be for you if:
* You demonstrate knowledge and experience of the Downstream Process.
* You possess logical troubleshooting and problem-solving skills.
* You have excellent analytical, written, and oral communication skills.
* You demonstrate an ability to work within a successful team.
To be considered for this opportunity, you should have a BS/BA/BEng in Life Sciences or a related field and 2+ years of relevant cGMP Manufacturing/Engineering/Scientific experience in a Drug Substance Biotech facility, along with deep technical knowledge of the Downstream Process.
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