Title: Formulation Scientist
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.
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
- 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 |
|
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 |
|
3 |
External Coordination |
Experience of working with third party manufacturing facility |
|
5 |
Quality approach |
Responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials |
|
6 |
Troubleshooting |
Drive troubleshooting for technical batches, clinical batches, and registration batches for injectable fill finish facility |
|
7 |
Compliance |
Responsible for writing & review of lab development and GMP manufacturing related proposals & report for client |
|
8 |
Responsible for managing GMP batch manufacturing documents |
|
|
9 |
Support for closure of QMS activities such as deviations, OOT, OOS & CAPA closure |
|
|
10 |
Support for client visit and audits |
|
|
11 |
Communication and interpersonal skills |
Responsible for cross-functional co-ordination |
|
12 |
Technical superiority |
Support for preparation of regulatory query response |
|
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 |
|
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.