Associate Scientist

Gilead Alberta ULC; Edmonton; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading company in biotechnology is seeking an Associate Scientist for Lab Manufacturing in Edmonton. The ideal candidate will have a strong background in GMP production and possess a relevant degree along with significant experience. You will be responsible for performing various manufacturing tasks, documentation, and supporting process development activities in a collaborative environment.

Qualifications

• Minimum 3 years relevant experience with a BSc; 2 years with an MS.
• Considerable GMP manufacturing environment experience preferred.
• Training in Company EHS policies is required.

Responsibilities

• Perform manufacturing tasks including GMP/non-GMP operations.
• Document work accurately in batch records and electronic lab notebooks.
• Train junior associates on required techniques and standards.

Skills

GMP manufacturing experience

Documentation skills

Data analysis

Collaboration

Education

BSc in chemistry or related science

MS degree

Tools

Microsoft Office

LES

ELN

EBS

GMax

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.
• 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.