Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Abbott Molecular has an opening in its Des Plaines, IL site for a PROCESS SCIENTIST, who would be responsible for multiple projects associated with process development and process scale-up for biologics, identifying and qualifying process equipment for new product introduction, and troubleshooting of combination products and biologics.
· Play a key role in planning and executing our Operations strategy required to support new product approvals and to meet legacy product regulatory commitments.
· Work across the organization driving and collaborating with functions in Development, Operation, Quality and Regulatory to assure the successful execution of our business goals.
· Participates in or leads complex projects for process investigations; design changes; resolving production issues and
· improving product availability and profitability.
WHAT YOU’LL DO :
· Coordinate and lead commercial product manufacturing operations with technical evaluation of scale up, validation, and technology transfer. This includes biologics product manufacturing (material preparation, mixing, filling, sealing, and inspection) and reserve samples (creation, storage, and testing).
· Troubleshoot issues with drug product processing technologies and equipment.
· Lead process development and provide training to manufacturing operators and junior colleagues for biologics and liquid formulations used in product processing in specific areas such as formulation development, process characterization, tech transfer, validation and biologics product manufacturing.
· Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory agencies, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
· Coordinate and manage multiple transfers of new device assembly requirements to manufacturing with hands-on technical support: including developing Six Sigma processes/documentation for routine commercial production.
· Projects involve leading and collaborating with cross-functional teams developing test plans, leading root cause analysis and participating in investigations. Also making presentations to internal/external customers, vendors, and senior management
· Develop, plan and track risk assessment for biologics operations non conformances, change controls, and implements appropriate CAPAs. Lead process modelling, data trending and advanced statistical & process analysis – present data/metrics to teams.
· Implement process improvement strategies to improve quality, reliability and/or reduce cost.
EDUCATION AND EXPERIENCE, YOU’LL BRING
B.S. required in a scientific discipline (chemistry; biology; biochemistry; chemical/biomedical engineering)
· Bachelor's Degree with up to 7 years of Biologics Process Development or Process Engineering experience
· Master's Degree with 5+ years of Biologics Process Development or Process Engineering experience
· Ph.D. degree with 3+ years Biologics Process Development or Process Engineering experience
· Demonstrated ability to apply operations knowledge in timely resolution of product / process technical issues.
· Experience with GMP.
· Experience with technical problem prevention / resolution.
· Knowledge of experimental design and/or chemical process modeling and/or statistical tools.
· Understanding change control impact on design / validation of products and/or processes.
· Experience in operations (manufacturing/quality).
· Experience with data management.
· Experience working in project teams for multiple complex projects.
· Experience with change control and/or investigation processes and/or
· Experience with acquiring, analyzing and interpreting data from a variety of sources
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
· Training and career development , with onboarding programs for new employees and tuition assistance
· Financial security through competitive compensation, incentives and retirement plans
· Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
· Paid time off
· 401(k) retirement savings with a generous company match
· The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
United States > AMD - Des Plaines : DP02
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf