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Principal - Process Sciences Associate United States,  


Posted on : 12 June 2017

Project Description

Req ID 33578 Title Principal - Process Sciences Associate City Branchburg State / Province New Jersey Country United States Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We re looking for people who are determined to make life better for people around the world. Responsibilities This position is responsible for the technical support of manufacturing operations. This position will interact with the engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. Interaction may be required with other Lilly site / contract producers of Lilly products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required. Spreadsheet experience is required. Database experience a plus.Responsible for supporting manufacturing operations through the performance of the following duties and representing TS/MS on Manufacturing Process Teams:Monitors (trends) and analyzes production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. Presents process data and analyses in Manufacturing Process Team meetingsTroubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Communicates issues in a timely manner. Leads process-related investigations and assesses technical impactAssists in the transfer of processes from process development to production facilities and from one production facility to another, anticipating and addressing scale-up issuesAuthors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studiesWrites standard operating procedures as they relate to the activities of the TS/MS group. Reviews and approves manufacturing batch records and other manufacturing documentationWorks directly with the Manufacturing staff on the manufacturing floor to share process knowledge. Assists in process-related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floorAs required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement continuous improvements to manufacturing processesWorks with Manufacturing to support the start-up and validation of new facilities and the associated process equipment. Helps to define and implement control strategies for Lilly Branchburg processesAs required, may lead or assist in the planning and execution of process validation activitiesAs required, may own or assist in the implementation of process-related change controlsUnderstands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP 33578BR Basic Qualifications BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering disciplineMinimum of 3 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environmentQualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position Additional Skills/Preferences Experience in fermentation/cell culture and/or protein purification manufacturingProcess and equipment knowledge of cell culture or purification functionsThorough understanding of GMP requirements for a large scale manufacturing facilityProcess validation experience a plusDemonstrated leadership skillsExcellent communication skills, both oral and written Additional Information Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Locations

New Jersey United States

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