Cell Culture Manufacturing Associate

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.

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/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.

All your information will be kept confidential according to EEO guidelines.