AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On Time. For more information, visit www.agcbio.com.
The Manufacturing Support Technician is an entry level position for an individual to support the Technical Operations group. Primary responsibilities include generating and editing documentation in support of Process Transfer activities, helping manage equipment procurement and implementation, reviewing technical documentation, and providing general support to Manufacturing improvement initiatives.
Work with the Technical Operations team to support the transfer of new processes into the Manufacturing operation. Key responsibilities include managing the creation of Manufacturing Batch Records, supporting development of Raw Material estimates, and helping to manage the closure of key equipment gaps.
Support the implementation of new technology into the manufacturing operation
Provide administrative support for the implementation of improvement initiatives within Manufacturing; strong computer skills is a must.
Provide support for close-out of Manufacturing deviations.
Interface with other departments to help ensure processes are transferred efficiently and that all equipment and documentation is ready for manufacturing operations.
Perform technical data review of completed documentation in support of regulatory submission for commercial distribution of a biopharmaceutical product.
KNOWLEDGE, SKILLS AND ABILITIES
Strong verbal and written communication skills
Ability to work in a fast-paced, dynamic environment, with limited supervision.
Demonstrated ability to multi-task
Ability to communicate, read, and write legibly in English
Strong computer skills sufficient to read and write email, review production schedules, read standard operating procedures
Detail oriented with the ability to complete written and verbally assigned tasks following specific procedures
Ability to interact constructively with peers and support groups
BS in engineering or science preferred
0-2 years of experience in a technical or science-based field
Dedicated personality with a strong drive to learn and add value
Communicate clearly, efficiently and accurately with internal team members and customers.
Strong technical aptitude including the ability to audit technical documents for appropriate data
Must be a self-motivated, self-organized individual capable of seeing tasks through to completion
Strong written communication skills
Experience with MS-based software (Word, Excel, etc.)
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE