The role of the Product Quality Specialist (IMP) is to provide ‘expert’ opinion on Investigation Medicinal Product (IMP) quality. A major component of the role will be supporting the company Qualified Persons in fulfilling their responsibilities for batch release and /or certification of Investigational Medicinal Products (IMPs). To this end, they will provide informed and high level batch review in line with project timelines. There will also be opportunity within the role to expand into the commercial products area of the business.
The successful candidate will possess a Bachelor’s degree (or equivalent) in a science discipline. He/She will have previous significant experience working within an established Pharmaceutical Quality System and possess previous experience in a customer facing role.
Proven knowledge of the legal requirements, rules and guidance covering the manufacture of Investigational Medicinal Products (IMPs) in Europe and the rest of the world is essential for this role. Excellent communication skills and an ability to manage multiple tasks simultaneously whilst maintaining a high level of accuracy are also essential skills required for this role.
Additional desirable criteria are listed in full within the job description/person specification attached to the online job posting.
An attractive remuneration package will reflect the importance of this role and will include 6.8 weeks annual leave, company pension scheme, enhanced sick pay and maternity entitlements, healthcare plan and opportunities for learning and development, as well as access to a company restaurant and parking facilities.
Job Reference Number:
40 Hours per Week
Internal and External Applicants
An opportunity has arisen for a highly motivated and experienced Bioinformatics Scientist to join a cutting edge company who provide innovative biomarker discovery and development services to the pharmaceutical industry.
In this role you will provide bioinformatics and computational support for a wide range of biomarker research and companion diagnostic product development projects, analysing large and complex datasets from a variety of data types including gene expression (array and qPCR), SNP/CNV and next generation sequencing data. You will specifically support the functional data analysis expertise within the team by handling the functional analysis & exploration of complex data sets and by the development/integration of functional data analysis methods to enhance existing protocols. Furthermore, you will be responsible for the development, delivery and support of novel computational & informatics software applications to support general biomarker discovery/development. In addition, the role will involve direct interaction with our pharmaceutical customers from offering advice on study design and analysis approaches to communicating results to multi-disciplinary teams comprising bioinformaticians, biologists and clinicians. This is a unique opportunity suited for a qualified bioinformatician with an interest in working with customers to deliver first class data analysis support and solutions.
The successful candidate will have obtained a minimum of an MSc in a relevant scientific subject, with the ideal candidate having obtained a PhD. In addition, he/she must have a detailed and applied knowledge of methods used in functional biomarker discovery using high throughput data, including but not limited to, study design principals, data processing techniques, exploratory/unsupervised analysis and functional analysis (e.g. pathway analysis, network analysis, GSEA). Industrial experience in a relevant role is highly desirable for this position.
Full details of essential and desirable criteria are listed within the job description/person specification attached to the online job posting
An attractive remuneration package will reflect the importance of this role and will include 6.8 weeks annual leave (including fixed closure days), company pension scheme, enhanced sick pay and maternity entitlements, healthcare plan and opportunities for learning and development, as well as access to a company restaurant and parking facilities
Internal candidates must possess a minimum of 6 months service within their current role if applying for vacancies within their Business Unit and a minimum of 12 months service if applying for vacancies in another Business Unit.
The service restrictions do not apply to the following:
- Individuals within 2 months of completion of a fixed term contract
- Individuals working at Almac on a temporary contract of service with an agency
- Individuals who have commenced in a new role for which they have not entered into a formal selection process (i.e. change of role/job title following annual performance review/appraisal; change of role/job title following restructuring exercise)
Please apply online at www.almacgroup.com
ALMAC Clinical Services
- 9 months ago