Downstream process development

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

All employees will consistently demonstrate alignment with our core 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

• Masters 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.