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 Process Transfer Technical Writer is a role for individuals with a STEM background that provides the opportunity to learn and support biotechnology manufacturing operations. Working under the direction of departmental staff, individuals in this role take part in generating key manufacturing documentation, resolving technical issues, and providing training to manufacturing operators.
Generating process instructions and batch records from pre-established templates, using source data and information provided, and as instructed and guided by Process Transfer Staff
Generating validation protocols from pre-established templates, as instructed and guided by Process Transfer Staff
Ensuring that required documentation is reviewed and approved by key technical and Quality subject matter experts in a timely manner
Obtaining process samples and submitting for analysis
Ensuring that test results are reported and recorded in spreadsheets and technical reports for analysis of process performance
Provide updated daily manufacturing schedules to internal and external clients and stakeholders
Scan and provide completed batch records to the client
Assist with writing and completing Quality investigations and corrective actions, such as CAPA, CRs, and deviations
Assist in performing validation studies by attending key process step execution, advising/training on sampling requirements, and ensuring that all required samples are obtained and submitted for analysis
Escorting client representatives observing manufacturing operations
Assist in providing training on batch record instruction and validation protocol requirements to Manufacturing and Quality control staff
Other duties, as assigned and as appropriateIn addition to these duties this role will also help provide assistance in process batch record writing and training.
KNOWLEDGE, SKILLS & ABILITIES:
Experience with GMP manufacturing
Demonstrated proficiency with Microsoft applications.
Strong analytical problem solving skills.
Strong verbal and writing skills.
Ability to work off hours (past 5pm and weekends) on occasion.
0+ years of relevant industry experience for this position
BS in science, engineering, or equivalent experience
Experience with SharePoint and MS Suite required.
Prior scientific laboratory, clean room, or GMP manufacturing experience, though not required, will be considered in reviewing potential applicants qualifications
Equivalent education and experience may substitute for stated requirements