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

1. Minimum 6+ years of experience working in an analytical laboratory (QC or R&D) on biosimilar products.
2. Strong scientific knowledge of analytical techniques with an adequate understanding of upstream and downstream processes.
3. Expertise in HPLC (routine operation, troubleshooting, and maintenance) with hands-on experience in RP-HPLC, SE-HPLC, IEX-HPLC, and N-glycan analysis.
4. Experience in instrument qualification, laboratory setup, and oversight of analytical equipment.
5. Proficiency in technical writing, including preparation of study protocols, method validation/qualification documents, and reports.
6. Hands-on experience with CE, HCD, and ELISA-based methods (e.g., HCP, residual Protein A) will be an added advantage.
7. Strong communication, interpersonal, and team-handling skills, with the ability to collaborate effectively across cross-functional and global teams

Roles and Responsibilites

1. Lead a team of analysts and oversee assigned analytical projects.
2. Provide analytical support during scale-up, global development, and technology transfer activities across the product lifecycle.
3. Perform and/or provide training on analytical methods including HPLC, gel/capillary electrophoresis, HCD, and ELISA-based methods, ensuring generation of high-quality data.
4. Prepare and review instrument SOPs, IQ/OQ documents, PV documents, MOAs, and technical reports.
5. Participate in equipment qualification and requalification activities.
6. Perform and support method development and method qualification activities.
7. Ensure availability of required consumables, reagents, and other laboratory resources.
8. Ensure analytical instruments are maintained in a qualified state, including timely calibration and performance verification.
9. 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