Career Category

Job Description

Role Description:

• Plan, schedule, perform analytical testing and approval of test results on raw materials, water, in-process control, drug substance and stability samples in GMP pharmaceutical environment.
• Troubleshooting issues related to analytical testing, techniques and equipment
• Conduct laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
• Support method verification and method validation/transfer for new product introduction (when required)
• Train new/ junior laboratory staff and ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to the job
• Support laboratory operations including but not limited to equipment qualification, calibration and maintenance, reagent/buffer preparation, chemicals/consumables inventory, laboratory housekeeping and document archival duties
• Perform periodic review of laboratory procedures and risk assessment.
• Author of SOPs/protocols/reports.
• Support regulatory inspections.
• Participate in continuous improvement initiatives and projects.
• Any other tasks assigned by the QC Manager

Education / Licenses

• Master’s degree and at least 2 years of directly related experience OR
• Bachelor’s degree in Chemistry, Biochemistry or related technological field and at least 4 years of directly related experience OR
• Diploma and at least 8 years of directly related experience
   

Relevant Experience

• At least 4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred.

Competencies / Skills

• Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods.
• Strong technical knowledge in and experience with the following QC Chemistry/ Biochemistry/ Raw material testing methods and equipment is required:
  • Immunosorbent Assay/Cell based Bioassay: Potency, Host Cell Proteins, ELISA
  • Chromatography: UPLC, HPLC, LC-MS, GC-HS
  • General Chemistry: Capillary Electrophosis, ICP-MS, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry
• Ability to preempt issues and disruptions to lab operations and deveop mitigation actions
• Problem solving skills with the ability to apply logic, utilize technical knowledge and assess data to troubleshoot issues and derive appropriate GMP decisions and solutions
• Experience in laboratory asset management, method qualification and transfers
• Ability to coach, mentor and/or cross train staff within core technical areas
• Good communication skills (technical writing and verbal communication/presentation)
• Interact effectively with cross functional team and ability to work well in teams
• Ability to manage multiple simultaneous activities in a rapidly changing environment

Additional Requirements

• Work on shift schedules may be required