Syngene Formulation Scientist Job For Pharma – Apply Online
Title: Formulation Scientist
Date: 12 Dec 2024
Job Location: Bangalore
Job Description
Job Title: Formulation Scientist
Job 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 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 Expectations for All Roles as per Syngene Safety Guidelines:
- Adhere to safe practices and procedures for self and the teams aligned.
- Contribute to developing procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity and quality standards.
- Promote a corporate culture of environment, health, and safety (EHS) mindset and operational discipline.
- Ensure completion of all mandatory training on data integrity, health, and safety measures for self and team members.
- Ensure compliance with Syngene’s quality standards at all times.
- Hold self and teams accountable for achieving safety goals.
- Govern and review safety metrics periodically.
Core Purpose of the Role
- Support product development for parenteral drug products, including pre-formulation, formulation design, process optimization & characterization, and technology transfer from R&D to manufacturing sites.
- Lead activities for transferring lab processes to GMP manufacturing sites and facilitate drug product manufacturing in GMP fill-finish facilities.
- Optimize manufacturing processes with a “right first time” approach to support drug product supply for clinical trials.
Role Accountabilities
- Hold self-accountable for achieving client milestones.
- Meet compliance-related expectations.
Leadership Capabilities
- Be self-driven and self-motivated.
- Demonstrate excellent communication and coordination skills to work with cross-functional teams.
Syngene Values
Employees are expected to consistently demonstrate alignment 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 molecules and large molecules.
Skills and Capabilities
Core Competencies:
- Develop parenteral drug products, including pre-formulation, formulation design, and process optimization.
- Extensive experience in de-formulation, comparability studies, and characterization.
- Expertise in analytical techniques and lyophilization cycle optimization.
Leading and Process Optimization:
- Successfully transfer lab processes to GMP manufacturing facilities.
- Develop a strong understanding of equipment and process control principles.
External Coordination: Work closely with third-party manufacturing facilities, ensuring effective knowledge transfer.
Quality and Compliance:
- Optimize manufacturing processes to ensure drug product supply for clinical trials.
- Drive resolution of deviations, OOT, OOS, and CAPA.
Troubleshooting: Address scale-up challenges and technical issues in GMP facilities.
Documentation and Reporting:
- Prepare and review GMP documents like BMR, BPR, PPQP, and PPQR.
- Contribute to regulatory filings and draft responses to regulatory queries.
Client and Audit Management: Manage client visits and audits with due diligence.
Project Management: Handle multiple projects within defined timeframes, identifying and mitigating risks.
Education: Master of Pharmacy (Pharmaceutics, Industrial Pharmacy, or Process Technology).
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