Sr Research Associate, Analytical Ops

Biopharma Careers; Edmonton; On-site; CAD 70,000 - 100,000; Full time

Job summary

Gilead in Canada is seeking a Senior Research Associate I, QC Chemist to support the ongoing manufacturing schedule in a 24/7 operation. The role provides Quality Control support on rotating 12-hour day/night/weekend shifts.

You will apply GMP guidelines (ICH Q7) and SOPs, conduct analyses of materials and products, perform calibration and maintenance, review data, and contribute to lab investigations and continuous improvements.

Qualifications

• Requires GMP experience and QC knowledge.
• Experience with analytical methods and data interpretation.
• Familiarity with SOPs and regulatory expectations.

Responsibilities

• Apply SOPs and GMPs (ICH Q7) to analyses.
• Conduct analyses of materials and finished products.
• Perform cleaning verification and instrument calibration.
• Review data and ensure accuracy against specifications.
• Assist in lab investigations.
• Participate in meetings and training sessions.
• Suggest improvements to test methods.
• Maintain lab cleanliness and safety.

Skills

Analytical data analysis

GMP/ICH Q7 knowledge

Lab techniques

Communication skills

Teamwork

Data review

Education

High School + Experience

Associate Degree + Experience

Bachelor's in Chemistry/Biology

Master's in Chemistry/Biology

Tools

Empower

LIMS

LabX

MS Word

MS Excel

Job description

At Gilead, we are creating a healthier world for all people. For more than 35 years, we have 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

The Senior Research Associate I, QC Chemist will support the ongoing manufacturing schedule. The position will provide Quality Control support in a 24/7 operation. Schedule will be a rotating, 12-hour shift that includes day/night/weekend hours.

Job Responsibilities

• Applies knowledge of site procedures (SOPs) and current Good Manufacturing Practices (GMPs) [e.g. ICH Q7].
• Conducts routine and non-routine analyses of raw materials, intermediates, and finished product samples.
• Performs cleaning verification analysis and visual inspection for manufacturing equipment.
• Reviews analytical data and results of testing to ensure accuracy and compliance to appropriate specifications and protocols.
• Assists in lab investigations as required.
• Participates in all group meetings and staff training sessions. May present data or prepare information for others to present.
• Suggests improvements to laboratory test methods, procedures when noted.
• Participates in weekly laboratory clean-up.
• Performs simple preventative maintenance and calibration of analytical instrumentation.
• Troubleshoots instrumentation and test methods.
• Writes and executes protocols and reports.
• Other duties as required.

Basic Qualifications

• High School and Five Years' Experience
• Associate Degree and Four Years' Experience
• Bachelor's Degree and Two Years' Experience
• Masters' Degree

Preferred Qualifications

• Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, NMR, KF titration, DSC/TGA, PSD, etc.
• Working knowledge of software such as Empower, LIMS, LabX, electronic notebooks, MS Word, MS Excel.
• Excellent technical and laboratory skills to execute analyses efficiently and reliably in cGMP regulated analytical environments.
• Demonstrates effective time management skills and ability to work independently and as part of a team.
• Ability to work effectively with people from wide range of skill levels and experience.
• Strong verbal and written communication skills.
• Technical Diploma with a minimum of 4 years of relevant experience; OR B.Sc. in Chemistry or Biology with a minimum of 2 years OR MS in Chemistry or Biology with a minimum of 0+ years required