Analytical Method Transfer - Small molecules (US)

Capgemini • Vancouver, BC

6d • $48,400 - $96,800 • Onsite

About The Position

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Requirements

• Understanding of the scope of the method transfer, overall timelines, and country specific requirements.
• Ability to define the analytical method transfer strategy, including identification of appropriate samples and acceptance criteria.
• Ability to build the associated transfer plan.
• Collaboration with subject matter experts to gather technical input.
• Authoring, reviewing and approving protocols, reports and other technical documents.
• Reviewing data from analytical method transfers and summarizing conclusions.
• Ensuring participating labs are prepared and activities are completed on time.
• Providing or coordinating technical support for issues, troubleshooting, and investigations.
• Providing regular updates on progress.
• Identifying potential risks, proposing mitigation actions, and communicating them.

Nice To Haves

• Non-clinical statistical data evaluation.

Responsibilities

• Collaborating with various functional groups (e.g.: method and specification owners, external laboratories, and internal QC and -stability laboratories, product quality integrators/-owners, regulatory affairs, external quality) to understand the scope of the method transfer, overall timelines, and country specific requirements.
• Defines the analytical method transfer strategy (including identification of appropriate samples and acceptance criteria) and builds the associated transfer plan. As needed, collaborating with subject matter experts to gather technical input into the strategy, including potential non-clinical statistical data evaluation.
• Authoring, reviewing and approving protocols, reports and other technical documents as appropriate.
• Reviewing data from the analytical method transfers, summarizing conclusions, including those from non-clinical statistical data evaluation as appropriate.
• Ensuring participating labs are prepared to commence the analytical method transfers and that all activities are completed on time.
• Providing or coordinating additional support for technical issues and/or troubleshooting, investigations related to the analytical method transfers.
• Providing regular updates to the project team and/or to functional management on progress.
• Identifying potential risks impacting scope of work and timelines, proposing mitigation actions and communicating these in a timely manner.

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed