About the Company

Syngene is an innovation-driven organization that offers comprehensive scientific services, spanning from initial discovery to commercial production. They operate as a contract research, development, and manufacturing organization. A core tenet of Syngene’s operations is an unwavering commitment to safety, which is integrated into all aspects of their work, professional conduct, and business performance. This commitment is reinforced through shared responsibility and accountability, emphasizing strict adherence to safety guidelines, procedures, and Standard Operating Procedures (SOPs) in both principle and practice.

Job Description

This role is for a Trainee/Intern within Syngene’s manufacturing facility, focusing on biopharmaceutical operations. The intern will be involved in the manufacturing processes for antibodies and other recombinant cell culture products, utilizing 2000L disposable reactors. A primary responsibility is ensuring strict compliance with Syngene’s safety policies and Environmental, Health, Safety, and Security (EHSS) requirements. The position involves active participation in manufacturing activities, proactive identification and resolution of operational gaps and risks, and precise execution of upstream processes. This includes managing batch processes, unit operations (like CIP and SIP), and accessory preparation, alongside meticulous monitoring of batch performance and data. The intern will be expected to maintain on-line documentation, adhere to cGMP practices in all manufacturing and associated activities (with QA, QC, and EAM), and attend mandatory training sessions covering EHS, cGMP, and HRD. Other duties include ensuring equipment qualification, verifying preventative maintenance, checking logbooks, confirming cleanroom readiness for line clearance, and coordinating with other departments for sample submissions and documentation closure. The role also entails initiating and processing upstream deviations and investigations, performing online documentation, ensuring cGMP compliance, and contributing to the continuous improvement of the Quality System by identifying system gaps. Leadership capabilities are not applicable for this role.

Responsibilities

• Active involvement in all manufacturing activities.
• Perform error-free operations by proactively eliminating operational gaps.
• Actively troubleshoot to minimize risks before and during execution.
• Execute upstream processes: manage batch processes/unit operations (including CIP, SIP, and preparation of accessories), and closely monitor batch performance and data.
• Follow and practice on-line documentation at all times.
• Adhere to cGMP practices during manufacturing activities and associated operations with QA, QC, and EAM.
• Attend training sessions on EHS, cGMP, and HRD.
• Ensure process equipment and instruments are in a qualified state.
• Verify PM schedules, check logbooks, and ensure cleanroom requirements are met to obtain line clearance from QA for batch execution.
• Actively coordinate with inter-departmental teams for sample submission, documentation closure, and timely execution of assigned tasks.
• Perform on-line documentation and ensure cGMP compliance in all manufacturing activities, with timely closure of executed documents and batch records.
• Ensure the Quality System is followed in day-to-day upstream operations and identify system gaps for improvement.
• Initiate and process upstream deviations/investigations and ensure their closure.

Qualifications

• Currently pursuing a Bachelor’s degree course or equivalent (e.g., B.Tech, B.Sc, Diploma).
• Possess a basic understanding of manufacturing processes and safety protocols.
• Demonstrate a willingness to work in cleanroom environments and adhere to hygiene standards.
• Exhibit good communication and teamwork skills.

Skills

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Other Information

Syngene is an Equal Opportunity Employer and provides 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. Syngene will also provide reasonable accommodation for qualified individuals with disabilities.

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