Manufacturing Associate
Proclinical is seeking a Manufacturing Associate for a leading biotech company located in Houston, TX.
Must be eligible to work in the US.
Job
Responsibilities:
Assist in Person-in-Plant (PIP) responsibilities and relevant oversight and support for cell therapy manufacturing at our CMO located in Houston (combination of onsite and remote support).
Willingness to regularly work the nightshift onsite at the CMO will be required.
Ensure processes and practices are compliant with current Good Manufacturing Practices (cGMP) and ensure robust production in GMP environment.
Provide technical inputs (as needed) for T-cell manufacturing process changes, process monitoring discrepancy/ deviation, and investigation evaluations and change control.
Engage in monitoring of manufacturing runs, maintaining a record of observations/alarms and assist in building a communication plan/triage (cross- functional).
Monitor CMO key performance indicators in alignment with company goals; maintain and report applicable metrics/ milestones.
Contribute to experimental plans to resolve investigations and/or to demonstrate proof- of-concept for proposed changes.
Maintain excellent working relationships and alignment with CMO functions; ensure effective resolution of technical and operational issues and escalation as needed.
Skills and Requirements:
Bachelors in a technical discipline (e.
g.
, biochemical/ chemical engineering, biotechnology or equivalent).
2
years' of relevant experience in pharmaceutical development and/ or manufacturing of biological drugs.
Prior experience working with CMO's on manufacturing operations/ technical support or quality assurance or tech transfer aspects for cell and gene therapies is a plus.
Experience in cell culture, aseptic processing, use of single use system and automation technologies is preferred.
Working knowledge of cGMP Quality systems (change management, deviation management and validation).
Working knowledge/ understanding of FDA regulations (GMP's) and industry standards.
Excellent collaboration, communication skills and ability to influence across multiple functions to get the job done.
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at +(1) 267-297-3280 or email protected .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-BC1INDSCIC Recommended Skills Alarm Devices Asepsis Automation Biochemistry Biology Biotechnology Estimated Salary: $20 to $28 per hour based on qualifications.
Must be eligible to work in the US.
Job
Responsibilities:
Assist in Person-in-Plant (PIP) responsibilities and relevant oversight and support for cell therapy manufacturing at our CMO located in Houston (combination of onsite and remote support).
Willingness to regularly work the nightshift onsite at the CMO will be required.
Ensure processes and practices are compliant with current Good Manufacturing Practices (cGMP) and ensure robust production in GMP environment.
Provide technical inputs (as needed) for T-cell manufacturing process changes, process monitoring discrepancy/ deviation, and investigation evaluations and change control.
Engage in monitoring of manufacturing runs, maintaining a record of observations/alarms and assist in building a communication plan/triage (cross- functional).
Monitor CMO key performance indicators in alignment with company goals; maintain and report applicable metrics/ milestones.
Contribute to experimental plans to resolve investigations and/or to demonstrate proof- of-concept for proposed changes.
Maintain excellent working relationships and alignment with CMO functions; ensure effective resolution of technical and operational issues and escalation as needed.
Skills and Requirements:
Bachelors in a technical discipline (e.
g.
, biochemical/ chemical engineering, biotechnology or equivalent).
2
years' of relevant experience in pharmaceutical development and/ or manufacturing of biological drugs.
Prior experience working with CMO's on manufacturing operations/ technical support or quality assurance or tech transfer aspects for cell and gene therapies is a plus.
Experience in cell culture, aseptic processing, use of single use system and automation technologies is preferred.
Working knowledge of cGMP Quality systems (change management, deviation management and validation).
Working knowledge/ understanding of FDA regulations (GMP's) and industry standards.
Excellent collaboration, communication skills and ability to influence across multiple functions to get the job done.
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at +(1) 267-297-3280 or email protected .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-BC1INDSCIC Recommended Skills Alarm Devices Asepsis Automation Biochemistry Biology Biotechnology Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
