Process Development Scientist, GMP Media

Job Description Summary

Job Description

Duties and Responsibilities

• Actas a technical lead and Subject Matter Expert (SME) in process development of GMP cell culture media products

• Apply Quality by Design (QbD) principles in designing and executing product and process characterization studies conducting risk assessments and identifying process controls and specifications

• Lead the technology transfer of manufacturing process to the GMP manufacturing team ensuring process information and controls are accurately captured in GMP manufacturing batch records and associated documentation

• Lead and/or participate in non-conformance root cause investigations to identify and resolve issues and provide recommendations on disposition and corrective/preventative actions (CAPA) as required

• Support GMP product maintenance and GMP process improvement initiatives by providing technical inputs and conducting studies as appropriate

• Collaborate across departments with cross-functional teams presenting technical information authoring technical reports and reviewing technical documentation

Knowledge and Qualifications

• Masters or Bachelors degree in a relevant scientific/engineering field with at least 5 years of relevant industry experience

• Advanced technical knowledge in process development and QbD principles and its practical application

• Knowledge of industry best practices in experimental design current good manufacturing practices (cGMP) and regulatory standards as they relate to the biotech/pharmaceutical industry

• Good understanding of change management with strong critical thinking and attention to detail

• Excellent written and verbal communication skills

#LI-KM1 #Onsite

STEMCELL Technologies is a privately owned Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality we are a company of Scientists Helping Scientistsstanding by our customers to provide the outstanding products technical support and training they need to advance their research. Scientists performing stem cell immunology cancer regenerative medicine and cellular therapy research are among those who rely on our cell culture media cell separation products instruments accessory products and services. Through our many regional offices as well as our distribution centers in Vancouver Seattle Grenoble and Singapore we deliver our innovative specialized products to more than 100 countries. With over 1800 employees globally most with scientific or engineering degrees STEMCELL is proud to be the largest biotechnology employer inCanada.

This is an opportunity to work with highly motivated colleagues in a science-oriented creative and dynamic environment. We offer a competitive salary excellent benefits and meaningful career development opportunities.

STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canadas Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.

As an equal opportunity employer STEMCELL is dedicated to ensuring that every employee feels safe valued and respected for who they are. We know that scientific progress and innovation occur when diverse creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.

The annual salary for this job ranges from:

STEMCELL determines an individuals pay within the range based on multiple factors including experience education job-related skills and equity within the team or organization. For jobs that are eligible for sales incentives the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company addition to base salary STEMCELL offers a comprehensive total rewards package including health benefits retirement savings and more.

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