Formulation Scientist (Parenteral)

• 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

• Responsible for product development for parenteral drug products, which includes pre-formulation, formulation design, process optimization & characterization, and technology transfer from R&D to different manufacturing sites.
• Lead all activities for transferring lab process to GMP manufacturing site and facilitate drug product manufacturing in GMP fill finish facility, in coordination with production and quality team.
• Responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials

• Hold self-accountable for the achievement of client milestone.
• Meet Compliance related expectation

• Self-Driven
• Self-Motivated
• Communication and coordination to deal with cross functional teams

• Excellence
• Integrity
• Professionalism

• Responsible for product development for parenteral drug products, which includes pre-formulation, formulation design, process optimization & characterization, and technology transfer from R&D to different manufacturing sites
• Lead all activities for transferring lab process to GMP manufacturing site and facilitate drug product manufacturing in GMP fill finish
• Experience of working with third party manufacturing facility
• Responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials
• Drive troubleshooting for technical batches, clinical batches, and registration batches for injectable fill finish facility
• Responsible for writing & reviewing lab development and GMP manufacturing related proposals & report for client

• Must have appreciable experience in parenteral drug products formulation and process development, from early to late phase including commercialization
• Expertise on selection and process/packaging development of vials, PFS, autoinjectors and its associated regulatory requirements for USA and Europe
• Extensive experience in de-formulation of reference product, comparability study and it's characterization
• Hands on experience for product and process development for both complex and conventional injectable Familiar with analytical characterization techniques for determining purity, potency and similarity assessment for biosimilars
• Good understanding of engineering principles & process controls related to equipment and processes across scales to transfer or receive processes/ injectable products
• Hands on experience on process validation and trouble shooting
• Hands on experience for working in GMP environment, ensuring data integrity and compliance to safety
• Good understanding of filter selection, filter optimization and filter validation studies
• Understanding of containment/isolator requirement for potent large molecules will be plus
• Know how knowledge for manufacturing process techniques for complex injectables such as liposome, nanoemulsions, polymer conjugates, nanoparticles, microspheres, and complex formation
• Expertise in design and optimization of lyophilization cycle for large molecules
• Handful skills for interpretation of results, drawing scientifically based conclusions, writing, and reviewing technical report
• Work closely with Manufacturing, quality, engineering, and validation teams of third-party manufacturing facility to achieve successful site technology transfer
• Knowledge of phase appropriate GMP quality system (early phase & late phase) and appreciable understanding of clinical study DP supply requirement
• Knowledge of preparing and review of GMP documents such as MFR,MPR, BMR, BPR, PPQP and PPQR
• Knowledge of QMS system, scientific methodology for handling product related deviations, OOT, OOS and CAPA, with full awareness of company's policy and procedures.
• Have a strong power of analysis, illustrated by the ability to quickly recognize the core issues, trends and risks assessment
• Earlier exposure to regulatory and client audit will be added advantage.
• Good oral communication and interpersonal skills for successfully driving programs involving multiple stakeholders
• Prior experience of contributing to regulatory filing of drug product dossier for regulated markets such as US, EU & ROW
• Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines.
• Earlier exposure to regulatory and client audit will be added advantage

Syngene International