Edmonton, AB, T5K 0Z7, CAN
5 days ago
Associate Scientist
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** **Associate Scientist, Process Development- Lab Manufacturing** This role is within the process development department at Gilead Alberta ULC, reporting to Lab manufacturing supervision. The position will be responsible for performing manufacturing (GMP/non-GMP), equipment/facility cleaning, equipment commissioning/qualification and environmental monitoring as well as Process Development. The position will be based in Edmonton Ab. **Key responsibilities:** + Provides input to batch records and flow charts related to equipment capabilities and operational practices. + Report and assist in deviation and safety investigations as appropriate. + Author, and review documents (SOP’s qualification reviews, work instructions etc) + Assist with required change control and perform reviews of executed documentation including batch records and protocols. + Operate and clean equipment in accordance with the relevant procedures and batch record. + Documents work in batch records or electronic lab notebook as appropriate while following relevant procedures. + Always maintain equipment and facilities in a GMP state during use and cleaning. + Act as a member of the PCL/kilo lab environmental monitoring team and perform sampling as required. + Participate in a shift rotation as required by the manufacturing schedule. + Files and retrieves project-related records that are maintained by the Process Development group. + Organizes and maintains the proper functions of a Process Development/manufacturing laboratory. + Assists supervision in training new and junior associates on techniques required for their duties ensuring that quality, safety and environmental standards are maintained. + Collaborates with contacts across areas and levels to accomplish project goals. May act as a resource for other research personnel within the department. + Plans and executes assigned experiments that support process development activities and project goals. + Operates scientific equipment, selects appropriate methods and techniques to perform experiments, analyzes data and prepares related reports. Properly documents the experiment and records results. + Assists senior personnel in preparing technical documents, such as reports and data required for Development Reports and Master Batch Records (MBRs). Participates in reviewing MBRs. + Participates in group/project team meetings. Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work. + Reports any deviations from Operating Instructions or SOPs to Supervision and seeks approval for corrective measures. **Safety and Environment** + Follows all procedures as outlined in the Company Environmental, Health and Safety Policies. + Attends departmental Environmental, Health and Safety and Quality (EHSQ) meetings regularly & completes all required Safety trainings. + Attends and obtains passing scores in all required GMP training sessions. + Ensures that he/she and any assigned staff have been trained on appropriate SOPs and/or hands on training forms before performing a task. **Basic qualifications:** + BSc degree in chemistry (or related science or engineering) and minimum 3 years of relevant experience or a MS degree and minimum 2 years of relevant experience. + Preferred qualifications and experience: + Considerable experience in a GMP manufacturing environment. + Experience in all Microsoft office tools. + Experience with tools such as LES, ELN, EBS, GMax an asset + Experience in commissioning and qualification an asset. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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