Title: Senior Associate - Commercial Attribute Science
Contract Length: 12 Months
Pay rate: €30 - €34/hour
Work Schedule: Monday to Friday, 37.5 H/W
Location: Dun Laoghaire, Dublin, Ireland
Our client is looking for a Senior Associate - Commercial Attribute Science to provide Process Development (PD) support primarily to the Forensics and Defect Laboratory at their bio-pharmaceuticals company. The successful candidate will have the opportunity to become an expert in forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.
Some of the key responsibilities for the a Senior Associate - Commercial Attribute Science will include:
- Leads / assists forensic investigation and identification of defects arising from drug product manufacture and write up investigations to cGMP standards.
- Establish experimental design, develop, and implement protocols, obtain reproducible and reliable results and communicate data to cross functional groups.
- Perform experiments, organise data and analyse results with minimal supervision (in a GMP laboratory environment)
- assist in deviations and resolution of root cause analysis.
Successful candidate will have:
- Third level bachelor's degree in science, engineering, or a relevant quality discipline with 2 - 4 years' experience in a similar role OR Associate's degree and 5 years of directly related experience.
- Experience in Working in a Laboratory Environment.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
- Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterisation, inspection, tech transfer (to commercial DP sites) or validation.
- Be familiar with advanced microscopy (scanning electron microscopy) and spectroscopy (Fourier-transform infrared spectroscopy).
- Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
- Excellent Communication skills are essential for this role.
Does this sound like you? If so, please apply today!
Get in touch to discuss this role!
My number is 020 7 551 0727