Execute laboratory operations directed towards the application of analytical methods for in-process testing, release, and characterization of biological products.
Conduct routine analytical procedures for in-process control samples and for product release of biologics and biopharmaceuticals such as Mab, recombinant proteins, or vaccines.
Work closely with process development team, external consultants and contractors for the establishment and technology transfer of analytical methods.
Responsibilities:
Perform laboratory testing and generate laboratory data pertaining to the potency of investigative vaccines. Experience with virus titration methods is highly desirable.
Conduct experimental procedures to support the qualification and validation of analytical methods.
Generate, manage, evaluate, and maintain critical data in a highly organized manner.
Assist in authoring high-quality technical memorandum, protocols, reports, summaries, and quantitative analysis, for the distribution and/or presentation to project teams, and for regulatory agency submissions.
Responsible for participating in new product technology transfer, and analytical qualification and validation activities to advance Hilleman’s portfolio pipeline.
Responsible for supporting any laboratory expansion activities.
Support the establishment of sound system/process to structure the development activities and information management to ensure the efficient delivery of a well- organized data package for IND- and IMPD-enabling development.
Interface with contract manufacturing and testing organizations (CMOs and CTOs) to achieve projects deliverables within the specified timeline.
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.
Proposes and implement resolutions to technical problems/issues.
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.
Education, Behavioural Competencies and Skills:
Fresh graduate in Biochemical Engineering, Biotechnology, Biochemistry or related Pharmacology discipline can be considered.
Hands-on experience and knowledge with modern laboratory techniques and equipment is essential.
Experience/knowledge of GMP quality control environmental preferred but not required.
Experience of analytical and QC testing of biologics is desirable.
Previous experience with statistics and assay variability analysis, as applied in biopharmaceutical environment will be a distinct advantage.
Strong problem-solving and risk-based decision-making skills for project advancement.
Excellent organizational skills and the 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, information effectively and work collaboratively as a member of a multidisciplinary team.
Comply with laboratory safety practices and standard operating procedures.
Schedule flexibility including weekend and occasional off-hours coverage.
