Associate Scientist

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.