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. 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 : 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. To 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. To responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials Role Accountabilities Hold self-accountable for the achievement of client milestone. Meet Compliance related expectation Leadership Capabilities Self-Driven Self-Motivated Communication and coordination to deal with cross functional teams Syngene Values All employees will consistently demonstrate alignment with our 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 & large molecules Skills and Capabilities: # Skills Capabilities Responsibility Expectation 1 Core Competency 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 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 2 Leading 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 Proven track record for successful completion of technology transfer of complex injectable formulation by using parametric and non-parametric scale-up methodologies Capable to effectively transfer the knowledge to team, through strong reporting and verbal communication 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 Deep understanding of filter selection, filter optimization and filter validation studies Understanding of containment/isolator requirement for potent large molecules will be plus Preparation and review of drug device combination documents will be additional advantage 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 3 External Coordination Experience of working with third party manufacturing facility Work closely with Manufacturing, quality, engineering, and validation teams of third-party manufacturing facility to achieve successful site technology transfer 5 Quality approach Responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials Knowledge of phase appropriate GMP quality system (early phase & late phase) and appreciable understanding of clinical study DP supply requirement 6 Troubleshooting Drive troubleshooting for technical batches, clinical batches, and registration batches for injectable fill finish facility Expertise in resolving scale-up challenges for drug products ranging from conventional injectables, complex injectables, pre-filled syringes and combination products 7 Compliance Responsible for writing & review of lab development and GMP manufacturing related proposals & report for client Well versed with the methodology for writing proposal, which shall include detailed scope of project, concise key deliverables, and breakup for project costing components 8 Responsible for managing GMP batch manufacturing documents Expertise in preparation and review of GMP documents such as BMR, BPR, PPQP and PPQR 9 Support for closure of QMS activities such as deviations, OOT, OOS & CAPA closure Well versed with 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 10 Support for client visit and audits Earlier exposure to regulatory and client audit will be added advantage Capable to handle multiple client audits with due diligence to system improvement 11 Communication and interpersonal skills Responsible for cross-functional co-ordination Strong management skills with wide experience of working/coordinating both internal & external partners Good oral communication and interpersonal skills for successfully driving programs involving multiple stakeholders 12 Technical superiority Support for preparation of regulatory query response Prior experience of contributing to regulatory filing of drug product dossier for regulated markets such as US, EU & ROW Expertise in drafting response to regulatory query 13 Agility Appreciable experience in handling multiple projects within defined timeframe 1. Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines 14 Support for client visit and audits Earlier exposure to regulatory and client audit will be added advantage Capable to handle multiple client audits with due diligence to system improvement Education: Master of Pharmacy (Pharmaceutics or industrial pharmacy or process technology) 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.
