Essential Duties and Responsibilities
Based on experience, coordination or management of GMP manufacturing readiness and tech transfer tasks as part of new product introduction (NPI) for client projects. Candidate will work with Bionova functional teams to ensure readiness of raw materials, documents, equipment, processes and facilities activities.
Generate and maintain GMP material bill of materials (BOM). Activities will involve using ERP system (e.g. QAD).
Ensure facility fit and tech transfer process working with internal process development teams, vendors, and clients.
Support tech transfer of processes using single-use equipment including but not limited to bioreactor, chromatography, depth filtration, VD and/or TFF.
Support US or DS equipment troubleshooting, authoring deviations, corrective actions (CAPA), and change controls.
Author and review technical documents such as reports, experimental plans, production batch records, training materials, and manufacturing SOPs per project needs.
Lead internal meetings and communicate effectively with internal stakeholders.
Contributes to quality activities such as investigations, authoring deviations, CAPAs, and Change Controls.
Undertake and successfully execute additional projects and assignments to refine and improve workstreams and systems.
Maintains own training within compliance and trains other upon completion of trainer qualification.
Documents work according to cGMP and cGDP.
Adheres to established regulations and follows cGMP established by site.
Working Conditions
This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
Qualifications
BS, MS, or PhD in Engineering, Life Sciences, or related discipline with 3-5 years (Engineer 1) and 5-10 years (Sr. Engineer) of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
Hands-on experience working in a GMP manufacturing facility with either upstream fermentation equipment (e.g. single-use bioreactor) or downstream purification equipment (e.g. chromatography).
Experience with process development, process characterization and/or tech. transfer processes.
Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
Experience with process monitoring software and equipment software (e.g. UNICORN, Pi Historian).
Experience with ERP systems (QAD).
Creative thinker that can identify better and more efficient methods to address issues and gaps.
Demonstrate ability to work independently, organize, and communicate effectively.
Ability to prioritize assignments and to manage multiple projects simultaneously.
The base compensation range for this role is $45 - $65/ hour. Base compensation is influenced by many factors including, but not limited to time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity and business/ economic conditions.
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
