Manager Manufacturing Operations

JOB DESCRIPTION

Job Title: Manager - Manufacturing Operations

Job Location: Bangalore     

Department: Pharmaceutical Development - FD

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

• 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

Role Accountabilities

• Lead and oversee end‑to‑end manufacturing of drug product manufacturing operations, including manufacturing and  packaging, and facility readiness in compliance with cGMP requirements.
• Ensure robust QMS, GDP, and data integrity compliance across manufacturing, qualification, and validation activities; review and approve SOPs, protocols, QRM, study reports, deviation investigations, and change controls.
• Provide technical and operational leadership for qualification, validation, and lifecycle management of DP equipment and facilities, including FAT, SAT, IQ, OQ, PQ, periodic requalification, and routine validation activities.
• Act as the primary interface with Engineering, Validation, Quality Assurance, and Cross‑functional teams for calibration, preventive maintenance, equipment commissioning, qualification planning, and manufacturing issue resolution.
• Own inspection readiness and audit management for regulatory and customer audits, including documentation review, audit trail oversight, alarm trending, inspection responses, and CAPA implementation.
• Drive people management and capability development, including training strategy, competency assessment, mentoring of executives/juniors, and building a strong GMP and safety culture within the department.
• Continuously identify and implement process improvements, risk mitigation strategies, and operational efficiencies in line with current regulatory expectations and business objectives.

Leadership Capabilities

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience: Relevant hands‑on experience in solid oral drug product manufacturing with strong exposure to Manufacturing formulation operations.

2. Education : Master’s or Bachelor’s degree in Pharmacy, or a Master’s degree in Pharmaceutical Sciences.

Experience: 7 to 10 Year’s

Skills and Capabilities

• Manufacturing operations, including manufacturing and  packaging, and facility readiness in compliance with cGMP requirements.
• In‑depth knowledge of QMS, GDP, data integrity, and regulatory requirements, with proven capability to review, approve, and drive SOPs, protocols, QRM, study reports, deviations, change controls, and CAPAs.
• Extensive experience in equipment and facility lifecycle management, encompassing installation, commissioning, FAT/SAT, IQ/OQ/PQ, periodic requalification, and routine validation activities.
• Strong cross‑functional coordination skills, enabling effective collaboration with Engineering, Validation, Quality Assurance, and other stakeholders for calibration, preventive maintenance, qualification, and issue resolution.
• Demonstrated capability in regulatory and customer audit management, including inspection readiness, audit trail oversight, alarm trending review, responses to observations, and CAPA implementation.
• Proven people management and development skills, including training strategy, mentoring, performance oversight, and fostering a strong GMP and safety culture within the manufacturing team.
• Ability to drive continuous improvement, risk management, and operational excellence aligned with current regulatory expectations and business objectives.

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.