Formulation Scientist at Syngene – MPharma Apply Now!

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:

• Overall adherence to safe practices and procedures of oneself and the teams aligned.
• Contributing to the development of procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity and quality standards.
• Driving a corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following 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 with Syngene’s quality standards at all times.
• Hold self and teams accountable for achieving safety goals.
• Govern and review safety metrics from time to time.

Core Purpose of the Role:

• Product development for parenteral drug products, including pre-formulation, formulation design, process optimization & characterization, and technology transfer from R&D to different manufacturing sites.
• Leading activities for transferring lab processes to GMP manufacturing sites and facilitating drug product manufacturing in GMP fill-finish facilities in coordination with production and quality teams.
• Responsible for optimizing manufacturing processes (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:

• Self-driven.
• Self-motivated.
• Strong communication and coordination skills to deal with cross-functional teams.

Syngene 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:

1. Core Competency:
   • Responsible for product development for parenteral drug products, including formulation design, process optimization, and characterization.
   • Expertise in de-formulation, comparability studies, and characterization.
   • Familiar with analytical techniques for purity, potency, and biosimilar assessments.
2. Leading:
   • Lead activities for lab-to-GMP manufacturing transfer and process validation.
   • Expertise in scale-up methodologies and compliance to GMP.
3. External Coordination:
   • Experience working with third-party manufacturing facilities.
   • Work closely with external teams for successful technology transfer.
4. Quality Approach:
   • Optimize manufacturing processes to support clinical trial drug product supply.
5. Troubleshooting:
   • Resolve scale-up challenges for conventional and complex injectables.
6. Compliance:
   • Responsible for creating and reviewing lab and GMP manufacturing-related documents.
   • Expertise in handling QMS activities like deviations, OOT, OOS, and CAPA closures.
7. Client Visits and Audits:
   • Handle client audits and regulatory inspections.
8. Communication and Interpersonal Skills:
   • Coordinate cross-functionally with strong management and communication skills.
9. Technical Superiority:
   • Contribute to regulatory filing and draft responses to regulatory queries.
10. Agility:
    • Manage multiple projects within defined timelines.

Education:

• Master of Pharmacy (Pharmaceutics, Industrial Pharmacy, or Process Technology).