Lead Injectable Manufacturing

JOB DESCRIPTION

Job Title: Lead Injectable manufacturing & Packaging

Job Location: Bengaluru

Department: FD - Manufacturing

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

Core Purpose of the Role: Responsible for Injectable dosage form manufacturing and packaging for Liquid Vials, Lyophilized vials and Prefilled Syringes for small molecules and large molecules.

Role Accountabilities

• Responsible for production & packaging management for Injectables for pilot and commercial plant.
• Contributing to development of procedures, practices and systems that ensure safe operations and compliance with the company’s integrity & quality standards
• Responsible for planning, organizing and ensuring that manufacturing is run-in cost-effective manner. And to ensure facility operation within the laid down annual revenue budgets.
• Documentation Management for review of the SOP's, EOPs, IOPs., BMR/BPR, QRA documentation
• Lead for FAT, equipment evaluation, risk assessment and equipment qualification.
• Responsible for facility planning to achieve weekly, monthly targets, capacity utilization, monitor and up keeping for smooth functioning of production activities, clinical batches manufacturing/commercial batches manufacturing.
• Co-ordination with other functions like project management, HR, Formulation & Development, Regulatory, QA & QC
• Management of QMS documentation as a part of review process of change controls, incidents, deviations – investigations, CAPA, OOS, OOT, Customer compliant, Audit management, APQR, validation protocols
• Responsible for implementation of cGMP requirements to meet compliance w.r.t. USFDA, EU, MHRA standards and lead client visits/audits, regulatory and QP audits.

Leadership Capabilities

• Proactive planning
• Decision making
• Process optimization & troubleshooting
• Effective communication
• Adaptability and problem-solving skills.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Looking for a thought leader with experience in manufacturing liquid vials, lyophilized vials, and pre-filled syringes.
2. Demonstrated Capability: Should have proven track record for working on small and large molecules and has faced FDA, EMEA and other regulatory audits.
3. Education: B. Pharm/M. Pharm/MSc.

Skills and Capabilities

• Should have exposure of Isolator based vials & PFS filling line.
• Should have experience of handling clinical supply, Exhibit and commercial batches.
• Should be well versed with Media fill, Trouble shooting.
• 21 CFR compliance, Equipment qualification EU annex 1.
• new product evaluation, Batch size selection, COGS,
• Environmental monitoring program for Sterile manufacturing.
• Batch record review, Exhibit and process validation, Packaging of vials & PFS etc.

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.