Job Description

JOB DESCRIPTIONJob Title: Senior AssociateJob Location: Bangalore, IndiaLevel: 9About Syngene : Syngene ( ) 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 spiritMandatory 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 ensures safe operations and compliance to company's integrity & quality standards
• Driving a corporate culture that promotes 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 environment, health, and safety (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 to 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:Role Overview: We are seeking a highly skilled and motivated individual for the position in the Manufacturing Science and Technology (MSAT) team, focusing on Upstream processes in biologics. The ideal candidate will possess a robust background in upstream process development for both mammalian and microbial platforms and will be instrumental in technology transfer, process scale-up, and client interaction. This role requires a strategic thinker who can effectively troubleshoot issues, adhere to timelines, and ensure compliance with cGMP and regulatory requirements.Key Responsibilities: * Inbound and Outbound Technology Transfer:

• Lead the technology transfer process for new and existing projects, ensuring a seamless transition from development to manufacturing.
• Collaborate with cross-functional teams to facilitate the successful transfer of technologies and methodologies.
• Process Scale-Up:
• Oversee the scale-up of upstream processes from shake flask/AMBR scale to 2kL/5kL single-use and stainless-steel bioreactors.
• Develop and optimize protocols for process scale-up, ensuring consistency and quality in product yield.
• Process Monitoring and Troubleshooting:
• Implement process monitoring strategies to ensure optimal performance during production runs.
• Identify and resolve issues in real-time, utilizing data analysis and troubleshooting techniques to maintain production integrity.
• Single Point of Contact (SPOC) for Awarded Projects:
• Act as the main liaison for awarded projects, ensuring all client requirements are understood and met.
• Communicate effectively with clients to provide updates, gather feedback, and address any concerns throughout the project lifecycle.
• Client Interaction and Requirement Understanding:
• Conduct meetings with clients to gather and clarify project requirements.
• Translate client needs into actionable plans, ensuring alignment with project timelines and objectives.
• Adherence to Timelines and QUOTIF:
• Monitor project timelines closely, ensuring adherence to QUOTIF (Quality on time in full) metrics.
• Proactively manage any deviations from the schedule and implement corrective actions as necessary.
• Process Mapping and Model Building:
• Create detailed process maps and build models to visualize workflows and identify areas for improvement.
• Collaborate with stakeholders to validate and optimize these models.
• Facility Fit and Gap Assessment:
• Conduct facility fit assessments to evaluate the compatibility of processes with existing infrastructure.
• Identify gaps in current capabilities and develop strategies to address these gaps effectively.

• Documentation Authoring:
• Author and review critical documents such as Technology Transfer Documents (TTD), protocols, and risk assessments.
• Ensure all documentation complies with regulatory requirements and is maintained accurately.
• On-Floor Support During Batch Execution:
• Provide on-floor support during batch executions, ensuring adherence to established protocols and addressing any immediate issues.
• Collaborate with the production team to ensure seamless execution of upstream processes.
• Additional Tasks:

Perform any other tasks assigned from time to time to support the team and project goals.Role Accountabilities:

• 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.

Syngene ValuesAll employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

• Qualifications:
• Education: Master's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field.
• Experience: 9-12 years of relevant experience in upstream process development and technology transfer within the biopharmaceutical industry.
• Technical Skills:
• Strong background in mammalian and microbial platform development.
• Expertise in process scale-up and bioreactor operations.
• Proficiency in statistical analysis software (e.g., Minitab, JMP, or similar).
• Familiarity with process mapping and modeling tools.
• Comprehensive understanding of cGMP and regulatory requirements.
• Soft Skills:
• Excellent communication and interpersonal skills for effective client interaction.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively in a fast-paced environment and manage multiple priorities.
• Additional Requirements:
• Willingness to work shifts and weekends as needed.
• Strong commitment to safety and quality in all aspects of work.

Equal Opportunity EmployerIt 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.

Syngene International