Bioprocess Technical Operations and… at Mallinckrodt… · Horsham

Summary: Keenova is a leading pharmaceutical company dedicated to developing and manufacturing therapies that improve patient lives. The internship offers hands-on exposure to pharmaceutical systems in a highly regulated GMP environment, contributing to laboratory operations and supporting Quality Assurance activities. Responsibilities: - Under close supervision, prepare buffers and execute laboratory experiments in support of the commercial Xiaflex manufacturing process including development, scale up, troubleshooting and deviations - Support and/or execute individually or with the larger team in fermentation and/or purification operations in the Bioprocess Technical Operations labs, as directed - Maintain equipment and supplies as needed for experimentation and general laboratory upkeep - Responsible for accurate and timely documentation of work in lab batch records and/or notebooks - To support the completion of migrating quality management systems, assist in reviewing documentation for accuracy in compliance with regulatory bodies, collect and collate metadata appropriately, and compile key metrics and performance indicators - Support organization of physical quality documents in document storage for electronic storage and archiving - Contribute and assist with data entry, trend analysis, process mapping, planning, and presentation of new policies, procedures and quality events - Participate in quality system activities such as deviation/CAPA tracking, change control support, audit preparation, or internal self-inspection tasks (as appropriate for intern level) - Participate in quality system activities such as deviation/CAPA tracking, change control support, audit preparation, or internal self-inspection tasks (as appropriate for intern level) Required Qualifications: - Must be currently enrolled in an undergraduate or graduate program - Actively enrolled in a relevant field of study such as Biology, Chemistry, Biochemistry, Biochemical Engineering, or other Life Sciences - Knowledge of MS suite products - Strong written and oral communication skills - Proficient in learning and understanding new PC software - General knowledge of Biology, Chemistry, Biochemistry, or basic Life Sciences through coursework or other internships - Critical Thinking - Ability to drive to and from work - Ability to work independently and collaboratively to facilitate completion of projects Required Skills: Bioprocess technology, Quality Management Systems Important Skills: Laboratory Management System, Electronic Document Management System Nice-to-Have Skills: PC software proficiency, General knowledge of Life Sciences, Critical Thinking, communication skills