Assay QC Scientist - Dun Laoghaire
Jenni at CK Group is recruiting for a Assay Scientist to join a company in the pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis.
The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
The Role: This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues. The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.
Key Responsibilities include:
- Experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable.
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Participate in the peer review of analytical data.
- Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
- Lead training of staff on technical aspects of job as required.
- Develop, revise and implement procedures that comply with appropriate regulatory requirements.
- Qualification of analytical equipment and related testing functions.
- Participate in Analytical Method Transfers.
- Ensure the laboratory is operated in a safe manner.
- Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
- Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
- Participate in the generation and update of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
Your Background: To be considered for the role you should have the following Qualifications, Knowledge and Experience:
- Excellent written and verbal communication skills.
- Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage.
- Knowledge of applicable Regulatory requirements.
- Experience with Regulatory inspections and interaction with inspectors is preferable.
- Experience leading cross-functional teams.
- Experience working with teams and influencing decision.
- Skilled in the use of problem solving tools/techniques.
- Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
- Prior experience in a pharmaceutical/healthcare Laboratory.
- Experience in Bioassays, Immunoassays and Cell Culture is essential.
- Possess key competencies to include planning/organisation, problem solving, communication, teamwork.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45071 in all correspondence.