Title:  Associate Manager

JOB DESCRIPTION

Designation: Associate Manager

Level: 7- I

Job Location: Bangalore

The Company

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key Result Areas

Role-specific:

Functional Responsibilities:

• Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production.
• Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics.
• Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance.
• Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Employ DOE and QbD principles for process optimization and robustness assessment.
• Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robustness and consistency in compliance with regulatory requirement.
• Prepare technology transfer protocols/descriptions and execute transfer to clinical and commercial manufacturing sites.
• Collaborate with downstream processing, analytical development, and quality assurance teams to ensure seamless integration of upstream processes.
• Liaise with regulatory affairs to ensure compliance with industry standards and guidelines.
• Analyze experimental data to draw meaningful conclusions and make data-driven decisions.
• Prepare and present technical reports, project updates, and scientific findings to senior management and stakeholders.
• Ensure that all upstream processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements.
• Prepare and review process descriptions and CMC sections of regulatory documents to support regulatory submissions as required for IND and BLA.
• Develop and implement strategic plans to achieve project milestones and goals.
• Mentor and develop team members to foster a high-performance culture.

Primary Responsibilities:

• Project Ownership: Accountable for the successful execution of projects from initiation through completion, ensuring all deliverables meet client expectations and regulatory standards.
• Quality Assurance: Responsible for ensuring that all processes comply with cGMP and other regulatory requirements, thereby safeguarding product quality and patient safety.
• Team Leadership: Mentor and guide junior team members, fostering a collaborative and innovative environment that encourages professional growth and development.
• Performance Metrics: Monitor and report on key performance indicators (KPIs) related to process efficiency, project timelines, and quality metrics, ensuring continuous improvement.
• Client Satisfaction: Ensure high levels of client satisfaction through effective communication, timely updates, and proactive problem-solving.
• Compliance and Risk Management: Identify and mitigate risks associated with technology transfer and process scale-up, ensuring that all operations are compliant with internal and external guidelines.
• Deliver high-quality statistical analysis and reports to support process optimization.
• Develop and validate process maps and models in collaboration with cross-functional teams.
• Adapt to additional tasks and responsibilities as assigned, demonstrating flexibility and a proactive approach.

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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.

Pls visit us at https://syngeneintl.com/ to know more about us and what we do.