Job Title: Asst. Manager - MSAT (ADL)
Competencies
Purpose of Job
The role involves working in the MSAT-ADL laboratory to support the analytical lifecycle of biosimilar products. Responsibilities include method development and qualification, providing analytical support during scale-up, process optimization, global development, and technology transfer activities throughout the product lifecycle.
Skill Required
- Minimum 6+ years of experience working in an analytical laboratory (QC or R&D) on biosimilar products.
- Strong scientific knowledge of analytical techniques with an adequate understanding of upstream and downstream processes.
- Expertise in HPLC (routine operation, troubleshooting, and maintenance) with hands-on experience in RP-HPLC, SE-HPLC, IEX-HPLC, and N-glycan analysis.
- Experience in instrument qualification, laboratory setup, and oversight of analytical equipment.
- Proficiency in technical writing, including preparation of study protocols, method validation/qualification documents, and reports.
- Hands-on experience with CE, HCD, and ELISA-based methods (e.g., HCP, residual Protein A) will be an added advantage.
- Strong communication, interpersonal, and team-handling skills, with the ability to collaborate effectively across cross-functional and global teams
Roles and Responsibilites
- Lead a team of analysts and oversee assigned analytical projects.
- Provide analytical support during scale-up, global development, and technology transfer activities across the product lifecycle.
- Perform and/or provide training on analytical methods including HPLC, gel/capillary electrophoresis, HCD, and ELISA-based methods, ensuring generation of high-quality data.
- Prepare and review instrument SOPs, IQ/OQ documents, PV documents, MOAs, and technical reports.
- Participate in equipment qualification and requalification activities.
- Perform and support method development and method qualification activities.
- Ensure availability of required consumables, reagents, and other laboratory resources.
- Ensure analytical instruments are maintained in a qualified state, including timely calibration and performance verification.
- Support seniors in laboratory budgeting, planning, evaluation, and implementation of laboratory procedures and systems.
Qualification Required
Mtech or MSc
Relevant skills / Industry experience
6+ years of experience working in analytical labs (QC or R&D) in the biopharma industry.
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213