Formulation Scientist Role at Syngene – MPharma Apply Online
Title: Formulation Scientist
Date: 6 Nov 2024
Job Location: Bangalore
Pay Grade: 8-I
Years of Experience: 3 – 6 Years
Job Description
Job Title: Formulation Scientist
Location: S18, Syngene, Bengaluru
Department: Formulation Development Centre (FDC)
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 a core priority both personally and professionally, ensuring adherence to safety guidelines, procedures, and SOPs.
Mandatory Expectations as per Syngene Safety Guidelines:
- Adhere to safe practices and procedures for self and aligned teams.
- Contribute to developing procedures, practices, and systems for safe operations and compliance with integrity and quality standards.
- Drive a culture that promotes EHS (environment, health, and safety) and operational discipline in the workplace.
- Ensure the safety of self, teams, and lab/plant by following safety protocols and EHS requirements.
- Complete mandatory training related to data integrity, health, and safety for self and team.
- Uphold Syngene’s quality standards.
- Hold oneself and teams accountable for achieving safety goals and review safety metrics regularly.
Core Purpose of the Role:
- Develop parenteral drug products, including pre-formulation, formulation design, process optimization, and technology transfer from R&D to various manufacturing sites.
- Lead lab process transfers to GMP manufacturing sites and support GMP fill-finish drug product manufacturing in collaboration with production and quality teams.
- Optimize manufacturing processes to support clinical trial drug product supply.
Role Accountabilities:
- Accountability for achieving client milestones.
- Meeting compliance expectations.
Leadership Capabilities:
- Self-driven and self-motivated.
- Effective communication and coordination with cross-functional teams.
Syngene Values:
All employees are expected to align with Syngene’s core values:
- Excellence
- Integrity
- Professionalism
Experience:
- At least 5 years of industrial research experience in formulation development and technology transfer of parenteral drug products for small and large molecules.
Skills and Capabilities:
- Core Competency
- Develop parenteral drug products, including formulation design, process optimization, and technology transfer.
- Experienced in parenteral drug product formulation, process development, and commercialization.
- Knowledgeable in vial, PFS, and autoinjector development, including regulatory requirements for the USA and Europe.
- Skilled in product and process development for complex injectables, with expertise in analytical characterization techniques.
- Leading
- Manage technology transfers of lab processes to GMP manufacturing facilities.
- Skilled in process validation, troubleshooting, and knowledge transfer to team members.
- Strong understanding of process controls, engineering principles, and GMP compliance.
- External Coordination
- Experience working with third-party manufacturing facilities.
- Collaborate with manufacturing, quality, engineering, and validation teams for successful technology transfers.
- Quality Approach
- Optimize manufacturing processes with a right-first-time approach.
- Knowledge of GMP quality systems for both early and late-phase clinical trial drug product supply.
- Troubleshooting
- Troubleshoot technical, clinical, and registration batches for injectable fill-finish facilities.
- Compliance
- Responsible for creating and reviewing GMP manufacturing proposals and reports.
- Experienced in preparing GMP documentation like BMR, BPR, PPQP, and PPQR.
- Quality Management System (QMS) Activities
- Handle product-related deviations, OOT, OOS, and CAPA with adherence to company policies.
- Client Visit and Audit Support
- Experience in handling regulatory and client audits, ensuring system improvements.
- Communication and Interpersonal Skills
- Cross-functional coordination and management experience.
- Proficient in oral communication and interpersonal skills for stakeholder engagement.
- Technical Superiority
- Experienced in preparing regulatory responses.
- Contributed to regulatory filings for drug products in regulated markets (e.g., US, EU).
- Agility
- Skilled in managing multiple projects, coordinating with functional and project managers, and adhering to project timelines.
Education: Master of Pharmacy (Pharmaceutics, Industrial Pharmacy, or Process Technology)
Link to Original Notification to apply: Apply here
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