Conducting experimental procedures to establish, optimise and qualify analytical methods for in-process control samples and for product release.
Involved in laboratory operations directed towards the development and application of analytical methods for in-process testing, release testing and characterisation of biological products.
To work within a multi-disciplinary and international team of employees and external consultants and contractors for the establishment and technology transfer of analytical methods.
To develop and demonstrate leadership by providing guidance and mentoring scientists or interns.
Responsibilities:
To assist in various laboratory operations in the development and application of analytical methods for Hilleman’s portfolio of products (such as mAb, recombinant proteins, bacterial and/or viral vaccines).
Perform laboratory testing to support the process development and process characterisation for biopharmaceuticals products including mAbs, recombinant proteins, vaccines.
Conduct experimental procedures to support the qualification and validation of analytical methods.
Generate, manage, evaluate, and maintain critical data in a highly organized manner.
Responsible for participating in new product technology transfer, and assay qualification and validation activities.
Preparation of high-quality technical memorandum, protocols, reports, summaries, and quantitative analysis, for the distribution and/or presentation to project teams, and for regulatory agency submissions.
Support the transfer of developed analytical methods from external partners and vice versa
Support the transfer of internally developed analytical methods to ACES GMP site include of qualification and appropriate validation
Support Department Head in project development strategies and planning and execution of deliverables.
Interface with contract manufacturing, regulatory and testing organizations (CMOs, CROS and CTOs) to achieve projects deliverables within the specified timeline.
Analysis of experimental data using statistical approaches.
Develop new analytical methods or improve existing methods by leveraging from journal articles and/or from knowledge of other scientists.
Partner with other groups in a matrix approach to ensure analytical development activities and analytical testing are fully supported and aligned with other functional groups such as Process Development, Project Management, Formulation Sciences and Drug Product Development and Quality Assurance to advance the programme.
Reviews, interprets, and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports and regulatory documents (IMPDs, IND).
As a subject matter expert, provides expertise to support function scientists, third parties, and other functions, to achieve the project goals and priorities.
Propose and implement resolutions to technical problems/issues.
Write and maintain accurate, complete, and timely data in laboratory notebooks and experimental records.
Prepare technical reports, summaries, presentations, protocols, and quantitative analyses of experimental procedures, data, and conclusions.
Supports local initiatives as directed by supervisor and participates in departmental or cross-departmental initiatives as appropriate.
To achieve deliverables in a timely fashion.
To 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:
Possess a PhD degree with at least 5 years of experience or Masters in Life Sciences with 10 years of experience.
A working and practical knowledge of modern analytical techniques and equipment as related to biopharmaceutical assay development, such as methods for measuring virus titre, protein and nucleic acids is essential.
Experience in a GMP quality control environment preferred and with experience in analytical and QC testing of biologics.
Previous experience with statistics and assay variability analysis, as applied in an industrial biopharmaceutical environment will be a distinct advantage.
A team player with initiative, drive and good communication skills.
