Act as technical lead and subject matter expert for laboratory operations directed towards the application of analytical methods for in-process testing, release, and characterization of biological products.
Execute laboratory operations to support early-stage development as well as IND and IMPD submissions for Hilleman’s portfolio of products.
Conduct routine analytical procedures for in-process control samples and product release of biologics and biopharmaceuticals such as Mab, recombinant proteins, or vaccines.
Work closely with the analytical development team, external consultants, and contractors for the establishment and technology transfer of analytical methods.
Responsibilities
Perform laboratory testing to support the process development and process characterisation for biopharmaceutical products including MAbs, recombinant proteins, and 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.
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.
Responsible for participating in new product technology transfer, and process qualification and validation activities to advance Hilleman’s portfolio pipeline.
Responsible for supporting any laboratory expansion activities.
Support the establishment of a sound system/process to structure the development activities and information management to ensure 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 project 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.
Propose and implement resolutions to technical problems/issues.
Support local initiatives as directed by supervisor and participate in departmental or cross-departmental initiatives as appropriate.
Prepare deliverables in a timely fashion.
Support and participate in daily laboratory operations, maintenance and all other duties as required.
Education, Behavioral Competencies And Skills
MSc in Biochemical Engineering, Biotechnology, Biochemistry or related discipline with a minimum of 4 years of relevant industry experience, or a BSc in a scientific discipline with a minimum of 6 years of relevant industry experience.
Hands-on experience and knowledge of modern laboratory techniques and equipment are essential.
Experience/knowledge of GMP quality control environment preferred but not required.
Experience in analytical and QC testing of biologics is desirable.
Previous experience in statistics and assay variability analysis as applied in a 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 and 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.
Schedule flexibility including weekend and occasional off-hours coverage.
Typical laboratory bending, stooping, and lifting requirements apply.
Lifting and moving supplies and equipment (up to 20kg).
Ability to wear PPE.
Travel Requirements
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Approximately 5 – 20%.
