SpecialistMS&T(AnalyticalSciences)

Job Purpose:

The Sr Specialist MS&T provides a range oftechnical 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.

Primary Responsibilities:

• Serving as a biologics 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

• 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.