The Scientist will be involved in designing, managing, and executing laboratory studies to support early-stage development as well as IND and IMPD submissions for Hilleman’s portfolio products. she will conduct experiments to establish, optimize, and qualify manufacturing methods for the production of biologics such as Mab, recombinant proteins, bacterial-based, yeast-based and/or viral vaccines. He/She will analyse data from studies, method development, or tech-transfer activities, and assist in authoring reports for submission to regulatory agencies.
Responsibilities
Perform/Support downstream processing operations using chromatographic filtration techniques, such as the ÄKTA system, membrane filtration, and viral reduction/removal filtration in the development and application of manufacturing methods for biological products.
Responsible for participating in new product technology transfer, and process qualification and validation activities to advance Hilleman’s portfolio pipeline.
Interface with contract manufacturing, regulatory, and testing organizations (CMOs and CTOs) to achieve project deliverables within the specified timeline.
Independently design, execute, and interpret studies aimed at developing suitable process steps/ scale-up/ down model and associated manufacturing processes.
Partnership in a matrix approach to ensure In-process control activities are fully supported and aligned with other functional groups such as Process Development, Analytical Development, Project Management, Drug Product Development, and Quality Assurance to advance the programme.
Assist in authoring high-quality technical memorandum, protocols, reports, summaries, and quantitative analysis for the distribution and/or presentation to project teams, and regulatory agency submissions.
Produce cell culture media, solutions, and buffers in support of lab-scale vaccine production.
Support local initiatives as directed by supervisor and participate in departmental or cross-departmental initiatives as appropriate.
Prepare deliverables in a timely fashion.
Provide expertise to support departmental scientists, third parties, and other functions to achieve the project goals and priorities.
Propose and implement resolutions to technical problems/issues.
Support and participate in daily laboratory operations, maintenance, and all other duties as required.
Local and/or overseas training attachment will be expected.
Education, Experience, Knowledge, And Skills
MSc in a scientific discipline with a minimum of 2 years industry experience, or a BSc in a scientific discipline with a minimum of 4 years industry experience.
Knowledge of chromatography, membrane filtration, virus reduction/removal, and process techniques and equipment related to biopharmaceutical process development at bench to pilot scale, are essential.
Detailed knowledge of the theoretical basis and objectives of experiments and how they fit into overall project goals.
Experience/knowledge of cGMP practices applicable to downstream manufacturing processes for microbial and mammalian cell culture derived biopharmaceuticals, process development and/or technology transfer is desirable.
Familiar with current applicable scientific literature and applicability to various projects, and application knowledge of statistical methods and tools for data analysis and interpretation.
Ability to investigate and develop new processes and technologies for project advancement.
Well-organized and detail-oriented, with the ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
Previous experience with Statistics and Design of Experiment (DoE) applied to an applied research and development as well as industrial biopharmaceutical environment will be a distinct advantage.
Strong problem-solving and risk-based decision-making skills for project advancement.
Excellent organizational skills and ability to manage concurrent deliverables and work effectively in a challenging, fast-paced environment.
Highly motivated team player capable of independent work with initiative and drive.
Excellent communication skills with the ability to present ideas and information effectively, and work collaboratively as a member of a multidisciplinary team.
Comply with laboratory safety practices and standard operating procedures.
Typical laboratory bending, stooping, and lifting requirements apply.
Lifting and moving supplies and equipment (up to 20kg).
Travel Requirements
• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Approximately 5 – 20%.
