Process Development Scientist, Biologics

Job type: Full-Time
Accepting BioReady™: Yes
Category: Research and Development
Salary:
Location: Vancouver, BC
Posted: September 6, 2019
Ends: October 6, 2019

Job Description Summary

The Process Development Department currently has an opening for a Scientist in the Biologics team. The Scientist will be responsible for conducting research and development that leads to efficient, robust and scalable protein production processes and their transfer to cGMP manufacturing. The Scientist will work in a dynamic and collaborative team environment with the opportunity to design and execute manufacturing process changes and process improvements as well as to lead development and cross-functional teams, while enhancing our ever growing biologics portfolio.

Duties and Responsibilities

  • Lead activities enabling the development and implementation of scalable protein production processes to meet project timelines.
  • Analyze data and perform calculations independently, identifying abnormal or unexpected trends, provide conclusions and future plans.
  • Organize and interpret results, present to cross-functional teams and management.
  • Lead technology transfer activities for developed processes to manufacturing production facilities.
  • Manage relationships with external vendors and CMOs, including potential travel for site visits.
  • Author and review laboratory notebook records, process descriptions, technical reports, technology transfer documentation, SOPs, batch records, regulatory filings and other documentation as needed for progression of assets.
  • Support manufacturing operations by using technical expertise to ensure successful manufacturing campaigns and support root cause investigations and identification of CAPAs.
  • Training, mentoring and management of team members.

Qualifications

  • PhD or MSc in Biology, Chemistry, Biochemistry, Chemical Engineering, Bioengineering or relevant discipline with minimum 4-7 years of relevant industrial experience.
  • Thorough understanding and hands-on experience of developing protein production processes with mammalian cell lines for use in a cGMP manufacturing environment is essential.
  • Exposure to ISO 13485 quality management system and cGMPs is essential.
  • Experience with authoring technical documents in support of internal investigations or regulatory submissions is essential.
  • Experience in technology transfer to manufacturing facilities, including CMOs, is essential.
  • Ability to foster a collaborative work environment with internal and external partners is essential.
  • Outstanding communication, people skills are essential.
  • Experience with authoring technical documents in support of internal investigations or regulatory submissions is essential.
  • Demonstrated ability to provide effective management for planning, coordinating and executing tasks and projects in a given time frame is essential.
  • Demonstrated ability to optimize processes for product yield, purity, efficiency and cost reduction is preferred.
  • Ability to train others on procedures, operations, new technologies is preferred.
  • Hands-on experience running lab and pilot scale experiments and equipment is required.
  • Experience in leading cross-functional teams and managing projects is required.
  • Experience with high throughput experimentation, micro, bench and pilot scale systems is desirable.
  • Management/supervisory experience is an asset.
  • Ability to sustain a high level of innovative and independent research contributing to platform development and improvement is an asset.
  • Experience with characterization of proteins and biological raw materials is an asset.
  • Knowledge of analytical sciences and method development is an asset.
  • Experience with scale-up/down process models and concepts is an asset.
  • Experience of DoE/statistical approaches and Quality by Design (QbD) concepts to experimental design and data analysis is an asset.

 

STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. 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, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore.  Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training.  We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree.  STEMCELL is proud to be the largest Biotechnology employer in Canada.

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 significant career development opportunities.

To apply please select the apply button. You will then be directed to a login screen asking you to set up an account. You must set up an account in order to apply. 

Create an account by selecting the create account button.  You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number.Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!

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