Lead small manufacturing team in scale up, technology transfer, and execution of manufacture of Antibody Drug Conjugates.
*** Coordinate and delegate all tasks and responsibilitiesassociated with GMP manufacturing operations and ensure successful manufacturing of custom biopharmaceutical Active Pharmaceutical Ingredients.
*** Collaborate with Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance teams.
*** Assist in writing scale-up cGMP batch record.
***Apply and incorporate pharmaceutical standards and rules, as per ICH Q7 (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), into documents, and day to day practice.
*** Ensure International Standards Organization accreditations are met.
*** Identify potential safety, quality, and compliance risks associated with technology transfer and scale-up.
*** Propose solutions to mitigate risk prior to manufacturing operations.
*** Act as source of technical expertise regarding analytical instrumentation and cGMP process equipment.
Join a well funded and innovative organization offering an industry competitive compensation package, bonuses, tuition reimbursement, full medical benefits, 401(k) retirement plan, life and disability insurance, career development opportunities, comprehensive vacation policy, and more!
Please reference #37463582 when responding.Education Requirements: Bachelor DegreeMinimum Experience Requirements: 2-5 yearsJob City Location: New BrunswickJob State Location: NJJob Country Location: USA