Abbott Process Development Engineer in Belgorod, Russia
Process Development Engineer
Core Job Responsibilities:
Formulates hypothesis, designs experiments (DOE), collects and analyzes data and presents solutions to R&D and manufacturing teams.
Partner with product development to ensure new formulation meets pre-established technology transfer readiness criteria (“bull’s eye”)
Lead scale up activity through pilot and manufacturing in conjunction with Product Development and Manufacturing Engineering teams. Provide Subject Matter Expert process support to operations during transfer campaigns.
Work with cross-functional teams to understand product/process risk and characterize processes to mitigate risk.
Author and review technical documents to support Technology Transfer activities.
Provide guidance on design of experiments, data analyses and derivation of appropriate conclusions to junior staff. Mentor junior staff in scale up and validation activities
Drive ongoing innovation and technology scouting activities, including networking opportunities which contribute to our development and help promote innovative technology and therapeutic ideas leading into novel drugs in the field.
Ensure that any issues related to product or process technology are identified, a root cause analysis conducted, and corrective actions implemented to ensure resolution. Lead transfer related investigations.
Develop and author Technology Transfer Protocols and Reports, review data summaries, technical reports, tech transfer packages, regulatory submissions and presentations
Lead/participate in evaluation of new technology and process automation for introduction into GMP manufacturing
Ensure high quality science, innovation, technology and deliverables, ensuring compliance with respective regulatory and quality requirements
Works closely with Technology Transfer Lead to establish and maintain a culture of learning and continuous improvement through capturing lessons learned and enabling cross-project collaboration
Responsible for the compilation of required GMP related and regulatory documents
Design and flawless execution of technology transfers from development to manufacturing
This position has a significant impact on the end results for successful completion of an assigned technology transfer
Acts as primary contact for all scale up/validation assigned technology transfers and is accountable for delivering on all assigned technology transfers to manufacturing sites (internal and external)
Technical oversight of site manufacturing personnel SMEs during Technology Transfer execution. Ability to guide manufacturing personnel in equipment qualification and cleaning validation
Key contributor for successful filings of high-quality CMC dossiers and approval of products.
- Advanced academic degree in a scientific or technical field, preferably in Engineering (pharmacy, chemistry, analytical chemistry, industrial engineering and management).
Minimum Experience/Training Required:
BS/MS in Chemical Engineering, Biochemical Engineering, Material science or related discipline with at least 10 years of relevant product and process development experience, as well as in authoring technical documentation to support regulatory submissions
Strong technical expertise in Process Design, Optimization & Scale-up, Technology Transfer, Process Analytical Technology and manufacturing support to large scale operation
Ability to influence, lead and drive change
Strong understanding of regulatory requirements in the industry and cGMP manufacturing considerations
Able to challenge current practices to constantly improve competitiveness, develop ideas and realize innovation.
Excellent communication skills in English, both verbal and written
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org