Sr Associate

Syngene International Limited; Bengaluru; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Syngene International Limited in Bangalore seeks a scientifically skilled professional in downstream purification for monoclonal antibodies. You will design purification processes, plan early phase to commercial batches, and support tech transfer and GMP documentation.

The role requires hands-on chromatography hardware (AKTA, Tofflon, TFF), data handling and cross-functional collaboration. Experience with EDMS/TrackWise and a strong grounding in GMP practices will be valuable in this role within

Qualifications

• Relevant practical experience in downstream manufacturing focusing on monoclonal antibody purification.
• Experience in scale-up and tech transfer is preferable.
• Knowledge of early phase, PPQ and commercial batches is preferable, not mandatory.
• Experience using electronic lab notebooks and EDMS/TrackWise is advantageous.

Responsibilities

• Design purification processes for monoclonal antibodies.
• Plan and execute early phase, PPQ and commercial batches.
• Support DSP team with buffers, column packing and system CIPs.
• Review/write protocols, reports, BMRs, PDRs and SOPs; perform risk assessment.
• Troubleshoot purification systems (AKTA, Tofflon, TFF) and optimize platform.
• Collaborate with cross-functional teams to enable successful batch execution and tech transfer.

Skills

Downstream purification principles

AKTA handling

TFF systems

Tech transfer

Documentation

Team collaboration

Education

Master's degree in Life Science/ Biotechnology

Tools

AKTA chromatography

Tofflon chromatography

TFF systems

Column packing station

EDMS/TrackWise

Job description

JOB DESCRIPTION

Job Location: Bangalore

Department: Biopharmaceutical Operations

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

• Designing of purification processes for novel fusion antibodies; antibody fragments and other new formats.
• Planning and execution of early phase, PPQ and commercial batches.
• Actively involve in scale-up and technology transfer to GMP manufacturing, experience in process fitment.
• Author protocols, reports, BMRs, PDRs, SOPs Risk assessment, Qualification and validation document. Review tech transfer documents, Risk assessment, Impact assessment and executed BMRs, PDRs, protocols & reports.
• Support the DSP team with basic activities such as preparation of buffers, column packing and evaluation, system CIPs, document issuance etc.
• Troubleshoot recipes in purification systems -AKTA, Tofflon & TFF System and develop long-term solutions for the betterment of purification platform.
• Strong hand on documentation as per GDP.
• Compilation of manufacturing data for further evaluation.
• Authoring technical reports and communicating the key findings.
• Participating in the weekly/daily team meetings.
• Work closely with cross functional teams and contribute to successful batch execution, knowledge sharing, best practices and continuous improvement initiatives.
• Supporting in breakdown management of downstream equipment and serve as point of contact to ensure smooth functioning of equipment.
• Support in CLM, LOM preparation for project and do risk assessment for all project incoming risk assessment.
• Actively participate in manufacturing investigations and propose effective corrective and preventive actions.
• Well versed with TrackWise or similar QMS systems.

Syngene Values

• Excellence
• Integrity
• Professionalism

Experience

• Relevant practical experience in downstream manufacturing process specifically with monoclonal antibody purification

Skills and Capabilities

• Working knowledge of downstream purification principles is essential for this role.
• Proficient in handling of AKTA, Tofflon chromatography, Manual and auto TFF Systems, column packing station
• Experience in scale-up and tech transfer is preferable
• Knowledge on early phase, PPQ and commercial batches is preferable not mandatory.
• Experience in using electronic lab notebook, Electronic Database Management System (EDMS), TrackWise is preferable.

Education

• Master's degree in Life Science, Microbiology, Chemical Engineering, Biotechnology, or related field.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.