ProClinical has a brilliant opportunity for a Manufacturing Associate (Cell Culture) to be based in the USA. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors.
Job Role and Responsibilities:
- Responsible for product-related operations in cell culture/fermentation and bioreactor operations. Primarily focused on cell culture activities; secondary focus and small scale inoculum preparation.
- Operates and maintains production equipment as it relates to cell culture - fermentation. Including, but not limited to: calibrations, preventative maintenance, initiating work orders, etc.
- Performs a variety of complex tasks under general guidance and in accordance with current GMPs.
- Experienced with drafting, executing, documenting and reviewing data, and approval of SOP's and batch records according to GMP guidelines.
- Maintain records to comply with regulatory requirements and performs daily in-process testing.
- Initiates deviations, assesses product quality impact, and proposes and executes Corrective and Preventative Actions (CAPA).
- Change owner for implementation or revision of equipment, documentation, and material specifications.
- Maintains daily workload schedule and relevant resource requirements.
- Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
- Develops effective working relationships with both internal and external partners.
Education, Skills and Experience:
- Preferred BS degree in Chemical Engineering, Biotechnology, Biology, Chemistry or related Engineering discipline with 3-5 years mammalian cell culture experience, or MS with at least 2 years' experience in upstream mammalian cell culture and cGMP manufacturing
- Associates degree with a minimum of 5 years' experience in upstream mammalian cell culture or upstream process development.
- Single use bioreactor and single use media preparation experience.
- Knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest.
- Experienced with manufacturing of bulk drug substance following SOPs and batch records within a cGMP regulated environment.
- Skill leading upstream production in absence of Associate Manager.
- Occasional off shift work and weekend work.
- On-call required for acknowledging alarms from equipment during off shift hours.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Cherilea Lomas on +1 267 405 6995 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.