Cell Culture Manufacturing Associate
About the role
Additional Information
All your information will be kept confidential according to EEO guidelines.
Company Description
Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com.
Job Description
Position 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.
• Provides detailed observations, analyzes data, and interprets results.
• 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.
• Provides training to new personnel in a specific technical process.
• Assisting in audits from internal or external partners.
• Performs other related duties as required.
General Responsibilities:
• Transparent and adheres to quality standards set by regulations and GMP policies, procedures and mission.
• Communicates effectively with managers, colleagues and subordinates.
• Ability to participate effectively as a team player in all aspects of GMP's.
• Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting GMP's strategic goals.
• Travels as needed.
Qualifications/Skills Required:
• Associates degree with a minimum of 5 years' experience in upstream mammalian cell culture or upstream process development.
• 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.
• Knowledge of specific product-related operations in cell culture/fermentation.
• Skill leading upstream production in absence of Associate Manager.
• Ability to ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
• Ability to mentor and train colleagues.
• Occasional off shift work and weekend work.
• 1st shift and/or possible swing shift, if necessary to meet manufacturing process schedule.
• On-call required for acknowledging alarms from equipment during off shift hours.
Qualifications/Skills Preferred:
• 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.
• Single use bioreactor and single use media preparation experience.
• Ability to observe technical issues and directs troubleshooting of process and equipment problems.
• Ability to operate with minimal supervision of complex systems and equipment and optimizes their use in manufacturing in accordance with GMP's.
• Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions.
Qualifications
Qualifications/Skills Required:
• Associates degree with a minimum of 5 years' experience in upstream mammalian cell culture or upstream process development.
• 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.
• Knowledge of specific product-related operations in cell culture/fermentation.
• Skill leading upstream production in absence of Associate Manager.
• Ability to ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
• Ability to mentor and train colleagues.
• Occasional off shift work and weekend work.
• 1st shift and/or possible swing shift, if necessary to meet manufacturing process schedule.
• On-call required for acknowledging alarms from equipment during off shift hours.
Qualifications/Skills Preferred:
• 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.
• Single use bioreactor and single use media preparation experience.
• Ability to observe technical issues and directs troubleshooting of process and equipment problems.
• Ability to operate with minimal supervision of complex systems and equipment and optimizes their use in manufacturing in accordance with GMP's.
• Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions.