OBJECTIVES:

The Analytical Science & Quality Control (QC) Analyst is responsible for supporting day-to-day operations in the Analytical Sciences (IPC) and Quality Control laboratories. This includes performing analytical testing to generate data for process development.

The role also includes ensuring compliance of analytical methods in alignment with current regulatory standards, across both Drug Substance (DS) and Drug Product (DP) manufacturing. These activities are conducted at a scale appropriate for clinical trial stage R&D/CMC development and GMP manufacturing operations.

The incumbent is also responsible to provide data trending and statistical support for periodic reporting including investigations for quality incidents e.g., OOS, deviations, CAPA in accordance with Hilleman Quality Policy, Standards and SOPs.

RESPONSIBILITIES:

General

General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc Establish Analytical Sciences (IPC) and QC procedures by drafting and reviewing functional SOPs including both GMP and non-GMP testing SOPs.
Perform testing, documentation and review of results within both a non-GMP and cGMP environment
Perform timely completion of testing and reporting of test results in support of manufacturing operations.
Train other analysts on methods and/or SOP. Participate/ support in AST(IPC)/QC or cross functional projects e.g., equipment qualification, method validation, method transfer, process improvement projects.
Support in equipment qualification and technical selection of AST (IPC)/QC equipment and/or standards and reagents.
Troubleshoot of analytical equipment and assist in the identification and resolution of equipment issues.
Problem solving of testing related issues as well as troubleshooting of equipment. Perform assessment for lab related deviations and identify corrective actions where necessary.
Work with tech transfer teams to prepare new processes; point of contact for ab operations for external customers. Set-up and coordinate detailed planning and document deliverables as per Master Plan and agreed timelines by working collaboratively within AST(IPC)/QC and cross-functional teams.
Participate in process improvement initiatives to enhance efficiency and product quality.
Lead/support quality incident e.g., OOx/ deviation and participate in Root Cause Analysis (RCA) and recommend corrective and preventive actions as applicable.

Analytical Sciences (IPC) Testing:

Responsible for laboratory testing to generate laboratory data pertaining to the process development of investigative vaccines.
Experience with virus titration methods, HPLC methods and other biochemistry and physical chemistry methods is highly desirable.
Partnership in 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 programs.
Propose and implement resolutions to technical problems/issues.
Support local initiatives as directed by supervisor and participates in departmental or cross functional 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.
Technical support as Subject Matter Expertise for AST (IPC) Topics.

Sample Testing Logistics

Responsible for Sample Management in AST (IPC) for sample planning and sampling execution.
Support Sample Management in QC for sample planning and sampling execution

Environmental Monitoring and Microbiology

Support Environmental Monitoring (Viable and Non-Viable) of cleanrooms, water and gases as per SOPs.
Support for coordinating Microbiological Testing of water/ raw material/ in-process/ finished product / stability/validation/utility samples as per approved SOPs.
Support for coordinating GPT, Sterility Testing and Microbial Identification.

Raw Materials

Provide technical support in the creation of Raw Material Risk Assessments and Raw Material Specification.
Responsible for coordinating Raw Material testing.
Perform Raw Material Quality Inspections on the ERP system

In-Process and Release Testing

Responsible for coordinating Raw Material testing.
Report In-Process and Release Testing to enable timely product release.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Basic Qualifications:

Bachelor’s degree / Diploma or equivalent, preferably in science, engineering or other related technical field.
Minimum of 3-7 years of relevant experiences, preferably in Quality Control, Analytical Science & Technology, Manufacturing including drug substance, fill/finish operations, or related field in the pharmaceutical industry (preferably vaccines or biologics industry).
Knowledge and experience on QC laboratory operations and procedures, analytical test methods, troubleshooting and evaluation of analytical results
Good knowledge and understanding of Biologics manufacturing, aseptic operations and cleanroom behaviour.
Familiar with regulatory requirements and local Codes & Standards especially in vaccines and biologics e.g., FDA, EMEA and ICHQ7

Preferred Key Skills, Abilities, and Competencies:

The role should possess in good understanding of the relevant regulatory environment, including applicable regulations and current guidelines for manufacture of medicinal products.
Knowledge and understanding of microbiology, analytical testing, QC systems and contamination control strategy.
Knowledge and experiences with GMP laboratory operations, data integrity requirements and associated laboratory equipment.
Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
Good verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management.
Ability to coordinate actions with multi-functions to ensure that the overall Hilleman quality requirements are met.
Experience in working with internal and external multifunctional teams.
Partner and influence other departments and functions throughout the organizations to implement ongoing product / process robustness to continuously improvement.

Hilleman Laboratories

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Analytical Science & QC Specialist