Syngene Bioassay Jobs For BSc, MSc, MTech Biotech – Apply Online

Title: Bioassay Analyst – Large molecules

Date: 19 Mar 2025

Job Location: Bangalore

JOB DESCRIPTION

Job Title: Executive or Senior Executive

Job Location: Bangalore

Job Grade: Level 9 (9-I or 9-II)

About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned.
• Contributing to development of procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity & quality standards.
• Driving a corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following EHS requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team, including self.
• Compliance with Syngene’s quality standards at all times.
• Hold self and their teams accountable for the achievement of safety goals.
• Govern and review safety metrics from time to time.

Core Purpose of the Role:

The candidate shall be responsible for performing the development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal Antibodies (mAbs) and other LMs. The candidate shall be responsible for method development, validation, and stability testing of drug substance/drug product. The candidate shall be willing to work in shifts.

Role Accountabilities:

• Develop and validate cell-based assays and binding assays (ELISA), SEC, and CGE, especially for monoclonal antibodies (mAbs), etc. Troubleshoot problems for these methods.
• Must have strong knowledge of the development of cell-based bioassays for monoclonal antibodies.
• Experience in qualification and validation of cell-based bioassays.
• Good documentation/laboratory practices such as ALCOA+.
• Broad knowledge of the analysis of cell-based assays to derive relative potency using software (such as Softmax Pro and PLA).
• Basic cell culture techniques and hands-on experience in maintaining mammalian cells. Must have experience in handling various cell lines (adherent and suspension cell lines).
• Preparation of mammalian cell banks for bioassays. Experience in handling primary and continuous cell lines, including revival, maintenance, cell bank preparation, and cryopreservation.
• Prepare raw datasheets, protocols, reports, and SOPs.
• Handling of QMS (Incidents, deviations, Out of Specifications, change controls, etc.) for GMP activities.
• Responsible for procurement and inventory maintenance of Pharmacopeial Standards, Chemicals, Reagents, Consumables, and Spares required for projects.
• Adhere to GxP/GMP/Safety procedures as defined in the internal standard operating procedures.
• Must have proficiency in MS Office (Word, Excel, PowerPoint), Outlook, and other essential tools required for routine activities.
• Experience in developing and validating SEC, CGE methods, especially for monoclonal antibodies (mAbs), is an added advantage.
• Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments is an added advantage.
• Good communication and email writing skills are required since the candidate needs to communicate with clients/external users situated overseas.
• Commitment to safety.

Behavioral Skills

• Good interpersonal skills.
• Self-time management.
• Good team player.
• Polite and good communication skills.

Syngene Values

All employees will consistently demonstrate alignment with our core values:

• Excellence
• Integrity
• Professionalism

Specific Requirements for this Role

Experience: 2-6 years

Skills and Capabilities:

• Development, validation, and routine testing of bioassay/ELISA, SEC, and CGE for monoclonal antibodies (mAbs) and other large molecules.
• Qualification and validation of cell-based bioassays.
• Able to follow instructions and perform tasks under the supervision of the Team Leader.
• Preparation and maintenance of all the documents.
• Experience in developing and validating SEC, CGE, and HPLC methods for mAbs is an added advantage.
• Theoretical knowledge of chromatography and spectroscopy techniques.
• Good documentation/laboratory practices such as ALCOA+.
• Good knowledge of MS Office (Word, Excel, PowerPoint) and email writing skills.

Education:

M. Pharm / M. Tech / M.Sc. / B.Sc. (Biotechnology/Biochemistry) with 2-6 years’ experience in a GMP environment (QC).

APPLY ONLINE HERE

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