Senior Specialist MS&T
- Dublin
- Contract
- CAPEX Projects
This vacancy has now expired
Do you want to be involved with exciting Pharmaceutical projects?
When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Senior Specialist MS&T.
This a fantastic opportunity to be involved with the critical investment projects both on-site and remotely.
Responsibilities:
- Serving as a biologics analytics and characterisation subject matter expert, providing technical input to teams, and coaching to associate staff. Provide technical leadership for:
- Experimental design, execution, data analysis and interpretation.
- Development,transfer and qualification of assays.
- Lead and support various manufacturing science and technology organisational initiatives as needed (examples include safety, financial forecasting, work standardisation, etc).
- Technical point of contact for Process Analytical Technologies (PAT)
- Technical lead for characterisation testing, ensuring testing conducted either internally or externally
- Serving as a key member during internal audits and external inspections/audits
- Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions
- Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus
Requirements:
- Demonstrated leadership and change management skills with a continuous improvement focus.
- A self-starter and results-focused, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
- S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
- With a Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry, the successful candidate will also ideally have a proven track record in delivering excellence.
- This role requires an experienced individual with a minimum of 6 years’ (for MSc), 8 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- Experience with assay development and qualification of biologics assays (HPLC-based, ELISA, etc). Familiarity with potency assays, including cell-based assays.
If this role is of interest to you, please apply now!
#LI-JS5
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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