at Abbott Laboratories in Scarborough, Maine, United States
PRODUCT TRANSFER SCIENTIST II: Abbott Diagnostics Scarborough, Inc. (An Abbott Laboratories Company) - Scarborough, ME & Westbrook, ME
Support business unit in executing the development and transfer of work in collaboration with others for projects. Leverage knowledge of cGMP regulations for medical devices and/or biologics manufacturing in product transfers. Work within the established Design Control process to transfer manufacturing equipment and processes for new products from R&D into Operations, or Commercial Scale Site to Site technical transfers. Review and modify manufacturing process instructions and procedures and Standard Operating Procedures (SOPs). Support and participate in government inspections and audits in an FDA regulated medical device product environment. Execute Corrective and Preventative Actions (CAPA). Correlate work, comprehend the relation, and provide suggestions of assigned problems to a larger one. Develop reports that direct recommendations, conclusions, and evaluate findings. Responsible for process validation in Medical Device, Pharmaceutical, or Biotechnology industries. Create, update, and review Master Validation Plan and other validation documents, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification). Work on the development of tests for existing platforms in a multi-disciplinary team with other scientists, chemists, and Operations personnel. Investigate problem areas and areas of desirable process improvement. Decide on and implement experimental procedures. Conduct test protocols, procedures, and product evaluations. Provide product claim substantiation to ensure efficacy and safety of new and existing products. Liaise with scientific and manufacturing communities. Carries out duties in compliance with established business policies. Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations. Performs daily technical expertise which include but not limited to product development projects, design change/change control, design review, product investigation, DHF remediation, product and knowledge transfer from R&D to manufacturing, etc. Review and approve validations for standard analytical techniques including HPLC, FPLC, UV-Vis spectroscopy, mass spectroscopy, gel electrophoresis, solid phase DNA/RNA synthesis, pH meters, centrifuge with knowledge of nucleic acid amplification and detection technologies and experience in aspects of lateral flow, molecular diagnostics, ELISA-based assays, and/or immunochromatographic devices.
Bachelor’s or foreign equivalent degree in Biological sciences, Chemistry, Engineering, Chemical Manufacturing Management, or in a closely related scientific or engineering field of study with at least 3 years of professional quality or manufacturing engineering experience. In addition, the position requires at least 1 year of professional experience in: (i) cGMP regulations for medical devices and/or biologics; (ii) creating, updating, and reviewing Master Validation Plan and other validation documents, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ); (iii) developing reports that direct recommendations, conclusions, and evaluate findings; (iv) liaising with scientific and manufacturing communities; (v) executing Corrective and Preventative Actions (CAPA); (vi) investigating problem areas and areas of desirable process improvement; (vii) transferring manufacturing equipment and processes; (viii) reviewing and modifying manufacturing process instructions and procedures and Standard Operating Procedures (SOPs).
An EOE. 40 hrs/wk. Respond by mail: Abbott Laboratories, Kathleen Ellwanger, Senior Paralegal, 100 Abbott Park Road, Bldg AP6A, Dept 32RC, Abbott Park, IL 60064-3500. Refer to ad code: ABT-00685-KE.