- Entry level
- No Education
- Salary to negotiate
The GSK Consumer Healthcare R&D team supports the development of leading global brands in Consumer Health care. Stability scientist is a specialized discipline providing support for new product development contributing to the growth of the Consumer Health Business.
The stability scientist role is to undertake activities to support the stability program of formal and informal stability studies. Their expertise is utilized by providing technical support for evaluating data to assigning shelf life and label storage statement.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Under supervision of stability team leader conduct stability related activities to support R&D product development and meet project milestones.
- Design stability strategies with consideration to meet global market requirements and regulatory guidelines (i.e. ICH/WHO). This includes design stability protocols for registration/ pivotal, In Use, Photostability, Bulk Stability, and Freeze Thaw/High Temperature stability studies.
- Proficient in LIMS or equivalent system to create and initiate stability protocols.
- Ensure that the stability facilities are maintained in a compliant state and manage stability samples in the chambers.
- Review of stability data to confirm expiry/shelf life support human use studies (i.e. sensory/clinical) to commercial launch and alerts project development team as appropriate. Utilize data analysis and sound scientific rational to establish expiry periods.
- Proficient in trend analysis using statistical software.
- If requested assist in the preparation of documentation including analytical methods, trend analysis reports, and stability summary reports for regulatory submission (3.2.P.8 sections).
- Confirms atypical and/or out of specification (OOS) results and participate in product investigation by applying root cause analysis and implementing effective CAPAs.
- Maintain awareness of global regulations that impact stability.
- Participate in internal and external audits.
- Develops strong, collaborative relationships with outsourced partner to help facilitate completion of external Stability activities.
- Able to work cross functionally as the role requires close collaboration with Quality, Regulatory and product development teams to ensure that technical data and documentation generated by Stability function meets the timeline and compliance. Why you?
We are looking for professionals with these required skills to achieve our goals:
- BS degree in Chemistry or Pharmaceutical sciences
- 3 years with Bachelors; 0 years with Masters
- A thorough understanding of the drug development process with a diverse product experience including registered and monograph drugs, medical devices, dietary supplements, cosmetics and foods.
- Ability to multi-task and adapt to changing business requirements in a fast- paced environment. Strategic planning and quick decision-making skills to meet timely organizational goals.
- Knowledge of ICH/WHO and other stability guideline.
- Experience working directly in stability program within the pharmaceutical industry.
- Strong understanding of stability study structure and managing stability chambers
- Good awareness of cGMP guidelines
- Excellent written and oral communication skills, ability to work well with others
- Ability to plan and execute work independently with minimal supervision; communication capability should extend to all organizational levels
- Preferably have working and/or hands-on knowledge and experience in some or all of the following techniques: HPLC, MS, GC, IC, KF, TLC, CE
- Proficient using LIMS (equivalent), Statistical software (i.e. Statistica/Minitab) Microsoft PowerPoint, Project, Word and Lotus Notes. Preferred Qualifications:
If you have the following characteristics it would be a plus:
- MS degree
About the company