Title:  ASSOCIATE SCIENTIST

JOB DESCRIPTION

Job Title: SENIOR ASSOCIATE SCIENTIST

Job Location: Bangalore

Reporting to:  Pradeep Jadiyappa

Job Grade: 8-II

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 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

Core Purpose of the Role :

• Biologics formulation research and development, formulation process scale-up, technology transfer to GMP fill-finish facility, design and conduct drug substance/formulation stability studies as required
• Author the technical document related to formulation development

Role Accountabilities

• Design and develop parenteral formulations for complex biologics
• Execute pre-formulation studies of biologics through rational design principles including structure function assessment, buffer/excipient/stabilizer screening, etc.
• Plan and execute drug substance/product stability studies, analyze data trend and support assessment of degradation kinetics and assign shelf-life.
• Author protocols, technical reports and communicate studies outcome to cross-functional groups.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience
   1. Should have a strong background in Biologics Parenteral Formulation development including solid and liquid dosage forms
   2. Experience in both early and late formulation development of mAbs and fusion proteins
   3. Good knowledge on Formulation and Process characterization studies
   4. Experienced in handling instruments like Density meter / Osmometer / Viscometer / Turbidity meter / UV Spectrophotometer / HPLC systems
   5. Ability to learn quickly, enthusiastic, sincere, positive attitude, hardworking
   6. Should have positive temperament, rational/logical thinking and enthusiasm to deliver on time, hardworking and committed.
   7. Basic understanding of statistics, DoE and data visualization

2. Demonstrated Capability
   1. Should be experienced/demonstrated formulation and process characterization.
   2. Authoring Technical documents like PDR, Tech transfer, study reports etc.

3. Education
   1. M.Eng, M.Tech, M.Pharm or M.Sc. in Life Science/Biotechnology/ Bioprocess Engineering/ Pharmaceuticals/Biopharmaceuticals/ Biopharmaceutical Technology/ Biochemistry or equivalent degree.