Descripción del puesto:
Your Role: As a Scientist 2 you will be responsible for the overall conduct of GLP or GMP studies as required. The Scientist 2 will provide scientific support to internal and external clients in relation to assays being conducted within the laboratory. Responsibilities include acting as Study Director or Responsible Scientist for routine GLP or GMP studies respectively, assisting in the performance of laboratory procedures, providing scientific support to laboratory staff performing routine procedures and external clients for whom the studies are being performed. The post holder is required to maintain study records, including deviation records, to meet regulatory standards.
The role of the Scientist 2 is a progression from Scientist 1. A Scientist 2 will take additional responsibilities including leading more complex studies and validations as appropriate.
* Acts as a Study Director or Responsible Scientist for routine assays and as such hold's responsibility for the overall conduct of GLP or GMP studies, respectively
* Works within the laboratory areas providing hands-on support, training, guidance and mentorship to laboratory based personnel to ensure routine client studies are completed on time to the appropriate scientific and regulatory standards
* Responds to audit observations through the Integrated Quality System
* Raises and progresses deviation and Corrective or Preventative Action (CAPA) records in a timely manner
* Writes and reviews regulatory documents including Standard Operating Procedures (SOPs), protocols, technical specifications and reports for routine procedures and assays
* Liaises with Commercial, Development Services, Programme Management and other Laboratory Operations to provide technical support for ongoing and upcoming projects, as required
* Participates in external and internal client conference calls, meetings and audits, including regulatory audits
* Proactively implements improvements to laboratory processes and procedures to improve efficiencies and reduce waste
* Responsible for ensuring all consumables and reagents relative to their studies are available in advance of study initiation
* Performs regular housekeeping and Health and Safety audits
* Ensures trending spreadsheets are completed in a timely manner for all studies in accordance with relevant SOP
* Writes and reviews assay risk assessments related to area of operational expertise
* Writes Genetically Modified Organism (GMO) risk assessments
* Actively maintains a clean, tidy and safe work environment
* Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures to ensure the welfare and safety of self and others
Who you are:
* HND or higher qualification in a relevant scientific subject
* Extensive experience working within a scientific laboratory, ideally within a regulated environment.
* Knowledge & understanding of GLP / GMP regulations.
* Computer literacy and entry of data into databases
* Actively updates skills and knowledge in order to remain professionally competent and aware of developments within scientific discipline and our industry.
* Knowledge & understanding of Molecular Biology techniques (e.g DNA extraction, QPCR, DNA sequencing)
Job Requisition ID: 2xxxx8
Career Level: D - Professional (4-9 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 8xx xxx xxx8 from 8:00am to 5:30pm ET Monday through Friday