About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
The Snr. Associate Scientist will provide scientific expertise on a variety of small-scale protein purification techniques to support process development, characterization, troubleshooting of manufacturing issues, and continuous process improvement. This role is a subject matter expert role within the Technical Development and Services, Biological Centre of Excellence Laboratory and is open to candidates with Downstream processing experience. Analytical experience or background would also be considered. Thorough understanding of GMP’s and ICH guidelines an advantage.
The candidate should have experience in bioprocessing of proteins (Enzymes, Antibodies), and more specifically have hands on expertise of small-scale laboratory purification techniques (e.g. AKTA systems, TFF, Filtration) and be familiar with chromatography, resin screening and filtration. The candidate will be involved in various cross functional projects that will involve high standards of collaboration with scientific peers across, Process Development, Manufacturing, Quality and Analytical Services.
RESPONSIBILITIES
List the major responsibilities of the job.
Laboratory /Project work:
- Accountable for designing and delivering assigned scientific projects & studies in line with overall BCoE business plan and technical agenda, with limited supervision.
- Accountable for the integrity of the data and scientific conclusions from assigned scientific projects.
- Support and lead root cause analysis investigations, troubleshoot processing problems and support more junior scientists with technical challenges and development of technical depth.
- Accountable for developing and maintaining small scale models and maintaining expertise in protein purification techniques and methodologies.
- Author protocols, work instructions, SOPs, risk assessments and technical reports to a high standard.
- Use scientific integrity and expertise to challenge the status quo and identify opportunities for improvement in lab practices.
- Accountable for developing & maintaining a high standard of Good Laboratory Practices (GLP).
- Responsible for developing cross functional project plans with other BCoE SME’s and stakeholders.
- Responsible for participating in the internal network of SME’s across the scientific and technical functions namely BCoE, Process Sciences and Analytical etc.
- Responsible for the communication and dissemination of scientific output to scientific & technical functions and BCoE stakeholders. (i.e. presentations to internal functions)
- Responsible for designing discrete studies/experiments with appropriate supervision.
- Responsible for maintaining a culture of empowerment, accountability and continuous improvement within BCoE.
- Responsible for contributing to strong cross functional relationships through promotion of science and the work of BCoE across stakeholder groups, specifically Technical Operations functions.
- Responsible for maintaining a culture of Operational Excellence, namely Standard work and 5S.
- Responsible for adhering to BCoE procedures and practices specifically in relation to laboratory operations.
- Accountable for the health and safety of self and colleagues working together
PhD degree in a relevant scientific discipline (Biochemistry, biotechnology, process engineering etc) with 0-2 years’ experience of laboratory scale downstream techniques*.
Master's degree in a relevant scientific discipline (Biochemistry, biotechnology, process engineering etc) with 3+ years’ experience of laboratory scale downstream techniques*.
Bacheolrs degree in a relevant scientific discipline (Biochemistry, biotechnology, process engineering etc) with 5+ years’ experience of laboratory scale downstream techniques*.
- Commercial scale experience will also be considered. Some experience in analytical science will be an advantage.Working knowledge of pharmaceutical regulatory requirements appropriate to level and understanding of the cGMP manufacturing process for Biologics.
Additional notes:
Laboratory work and manufacturing support activities will require the use or proximity of chemicals, laboratory and manufacturing equipment and instruments, and mechanical moving parts. Noise and vibration may be present.
Periodic week-end laboratory work and/or on call support will be required on a team rotation basis.
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