Formulation Scientist (Parenteral)

JOB DESCRIPTION

Job Title:Formulation scientist

Job Location:S18 Syngene Bengaluru

Department: Formulation Development Centre (FDC)

About Syngene:Syngene () 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 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 companys 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 integrityhealth 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 :

• 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

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 3 years of industrial research experience in formulation development and technology transferof parenteral drug products for small molecules & large molecules

Responsibilities:

• 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

Skills and Capabilities:

• 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 its 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 understandingof filter selection filter optimization and filter validation studies
• Understanding ofcontainment/isolatorrequirement for potent large molecules will be plus
• Know how knowledge for manufacturing process techniques for complex injectables suchas liposome nanoemulsions polymer conjugates nanoparticles microspheres and complex formation
• Expertise in design and optimization oflyophilization cyclefor 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 appropriateGMP quality system(early phase & late phase) and appreciable understanding of clinical study DP supply requirement
• Knowledge of preparing and review of GMP documents such asMFRMPR BMR BPR PPQP and PPQR
• Knowledge of QMS system scientific methodology for handling product related deviations OOT OOS and CAPA with full awareness of companys 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

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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.