Senior Specialist in Analytical Science

Job Description About PSC Biotech Who we are? 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.  Senior Specialist in Analytical Science   Job Purpose:   The Sr Specialist MS&T (Analytical Sciences) provides a range of analytical technical support to the site in particular Manufacturing Sciences and Technology (MS&T) Process Sciences, Manufacturing and Quality Control, Acting as Analytical Method and PAT SME while taking a lead in utilising the latest innovations in technology and automation to create a workplace of the future. Requirements Primary Responsibilities:   Serving as a biologic’s analytics and characterization 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 organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc). Technical point of contact for Process Analytical Technologies (PAT) Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions Technical lead for characterization testing, ensuring testing conducted either internally or externally Serving as a key member during internal audits and external inspections/audits Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus   Qualification and Experience:   General competencies: Demonstrated leadership and change management skills with a continuous improvement focus. A self-starter and results-focussed, 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.   Technical: Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules.    Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus. Significant amount of Analytical Chromatography experience ideally with some Mass Spectrometry experience Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software) Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes   Minimum Education/Experience: 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. #LI-BR1 Requirements Primary Responsibilities: Serving as a biologic’s analytics and characterization 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 organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc). Technical point of contact for Process Analytical Technologies (PAT) Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions Technical lead for characterization testing, ensuring testing conducted either internally or externally Serving as a key member during internal audits and external inspections/audits Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus Qualification and Experience: General competencies: Demonstrated leadership and change management skills with a continuous improvement focus. A self-starter and results-focussed, 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. Technical: Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus. Significant amount of Analytical Chromatography experience ideally with some Mass Spectrometry experience Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software) Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes Minimum Education/Experience: 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. #LI-BR1