Investigator, Analytical Technology Transfer

Basic qualifications:

  • Bachelors degree in Biochemistry, Chemistry or Biology and at least 5 years relevant experience OR PhD/MS degree in Biochemistry, Chemistry or Biology with minimum 3 years relevant experience
  • Prior experience and familiarity with GLP regulations
  • Prior experience with and thorough knowledge of cGMP requirements
  • Previous Biopharmaceutical experience

Preferred qualifications:

  • Experience in the use and application of USP, EP and ICH guidelines relative to analytical method qualification (fit for use), validation and methods transfer
  • Industry experience with GMP testing in a team based laboratory environment using biopharmaceutical associated analytical methods (e.g. Capillary Gel Electrophoresis, Capillary Isoelectric Focusing, SEC/CEX-HPLC, UV/VIS, Bioassay)
  • Familiarity with regulatory requirements and expectations as they relate to specification development and participation in the regulatory submission processes is also preferable.
  • Good communication skills and experience in working within a team or matrix environment is essential.
  • Occasional domestic or international travel required.

Details:

The Analytical Technology Transfer and Validations team has positions open at the Senior Scientist level. This team is responsible for the coordination, design, execution and oversight of analytical method transfers and validation requirements to support all phases of biopharmaceutical pre-clinical development through commercial release. These positions do not involve routine hands on laboratory bench work, and focus on the overall management of the analytical technology transfer, validation and related activities.

  • Collaborate with internal development groups and serve as a liaison on technical issues with both internal and external contractors.
  • Support the knowledge sharing and effective transfer of analytical methods to and from designated testing sites.
  • Provide strong technical writing abilities and experience in authoring and modifying method SOPs, qualification/validation protocols and technical reports.
  • Provide data review to ensure and monitor the ongoing performance of analytical methods.
  • Own and manage method life cycles, apply appropriate statistical tools to assess assay capability, and develop method transfer/validation strategies consistent with ICH requirements and current regulatory opinion.
  • Apply a strong working knowledge of biopharmaceutical quality control or development laboratory environments using FDA/ICH regulations and guidance.
  • Work closely within and across interdepartmental matrix teams to ensure harmonization of release, stability and technology transfer testing practices.
  • Contribute to product specification development and ensure alignment with process and method capabilities.
  • Actively involved with project matrix teams as assigned to support the progression of the analytical work package from development through commercialization.
  • Ability to work independently and collaboratively, ensuring appropriate change management is utilized.
  • Contribute to the authoring and review of CMC sections for regulatory submissions including INDs, BLAs, and related documents.

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.


Meet Some of GlaxoSmithKline's Employees

Jasdeep

Procurement Associate

Jasdeep finds diverse suppliers to build GSK’s pipeline. He organizes joint ventures with companies and negotiates pricing rates and payments to build a seamless supply system for GSK’s materials and products.

Andrea

HR Associate, Future Leaders Program

Now in her second rotation of GSK’s Human Resources Future Leaders Programme, Andrea is shaping the future of talent management within Research and Development, from workforce assessments to strategy and operations.


Back to top