The Stability Coordinator (SC) will establish and maintain the stability storage and capabilities of the Biopharmaceutical Central Testing Laboratory (BioCTL). These activities include the management of facility, equipment, stability documentation and IT systems (as applicable). The SC will be responsible for planning and coordination of the Stability program for the BioCTL. This requires liaison with all projects from both within GSK or with Third Parties. The role will ensure that stability protocols and commitments for all projects are defined, coordinated and planned to ensure the timely delivery of all relevant data. The Role will require the management of a stability storage area along with storage vessels and temperature monitoring and response. Stability protocols that are derived from projects will be coordinated and implemented. This requires the regular interface with all analytical functions (including off-site testing), coordination and initial review of data and compilation of stability reports. Liaison with statisticians and analysts will be required in order to generate stability reports. Associated data and documentation are the responsibility of the SC. This role requires the speedy resolution of stability issues within the BioCTL and an understanding of the resource planning of the BioCTL. The SC will represent the BioCTL in project discussions where the scope is primarily stability planning.
- To oversee and maintain the BioCTL Stability studies for all projects for which the BioCTL is accountable. This includes management of the stability facilities and equipment, management of stability documentation, management of stability sample inventory, capacity planning for stability studies and operating in a cGMP and QMS compliant manner.
- To prioritise activities, anticipate stability time point clashes and manage the delivery of stability time point testing and data.
- To liaise with BioCTL analytical management over the review of data, and with statisticians over the analysis of data.
- To actively manage stability studies relating to new product and in-licensing projects into the BioCTL
- To liaise with stakeholders e.g., External Supply, R&D over initiating new stability studies, the ongoing stability support program, deviations, changes, strategic decisions, stability report completion, study closure and lead responses to all enquiries relating to stability.
- To manage contingency planning and business continuity planning with respect to Stability including contribution to the Governance and Risk Management processes for the BioCTL
- To interface with the Stevenage laboratory service providers over the provision of Out of Hours support and temperature alarm generation and response.
- To ensure systems and utilities are inspection ready and contribute to Level 1, Level 2, Level 3 and Level 4 corporate, customer and regulatory audits.
- To network with Quality colleagues in GMS, R&D and Third Parties to ensure that the BioCTL leverages the best practices for stability.
- To generate appropriate stability documentation in support of regulatory submissions.
Knowledge/ Education / Previous Experience Required*
A. Educational Background
List any academic or practical education that must be obtained to be qualified to perform this role.
1. Minimum Level of Education*
Bsc or equivalent in Life Sciences
Area of Specialisation*
Why is this Level of Education Required?
Required to effectively fulfill the role
2. Preferred Level of Education
Bsc in Chemistry or Biochemistry
Area of Specialisation
Why is this Level of Education Preferred?
Directly relevant to role requirements
B. Job-Related Experience
Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.
Minimum Level of Job-Related Experience required
5 or more years experience with biopharmaceutical stability studies and/or biopharmaceutical testing
Why is this Level of Experience Required?
Required to effectively fulfill the role
- C. Other Job-Related Skills/Background
- List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
- Prior analytical testing and stability management experience in pharmaceuticals for five years or more is required. Validation experience in biopharmaceutical operations of three years or more is a preferred requirement.
- Demonstrated high level knowledge in the understanding and running of biopharmaceutical stability studies.
- Knowledge in bioassays, biopharmaceutical assays, statistical evaluation of assay variability and sample management is preferred.
- Knowledge in current standards of laboratory equipment validations is preferred.
- Knowledge in use of LIMS, LIMS stability modules and electronic stability packages is preferred.
- Knowledgeable in cGMP and regulatory requirements
- Must be familiar with established documentation practices for stability programs.
- Strong interpersonal and organizational skills. Must have demonstrated self-directed work habits.
- Must be able to provide leadership to generate options to resolve problems, prioritize solutions, select optimal solutions, and implement decisions.
- Strong verbal and written communication skills.
- Experience of safety and environmental risk assessments for laboratory operations