Title:  Specialist Development QA_Development Biology

Job Title: Specialist Development QA Development Biology

Department: Discovery and Development QA

Job Location: Bengaluru, India 

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

 The 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 the development of procedures, practices and systems that ensure safe operations and compliance with the company’s integrity & quality standards
• Driving a corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline at all times in the workplace.
• 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 training related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance with Syngene's quality standards at all times
• Hold yourself and your teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

 Core Purpose of the Role:

Key Responsibilities:

1. Responsible for driving Phase gate for Product Development across Biologics Development functions.
2. Review and Assess risk associated with Analytical Methods and Mitigation Plan.
3. Review and provide inputs on analytical methods to have robust methods.
4. Review and approval of Analytical Technology Transfer from Development services to Quality Control.
5. Review and approval of Method transfer documents and Specifications for all early and late phase programs.
6. Review and approval of Method development reports and QbD reports during Method development.
7. Review and approval of Method Qualification and Method transfer protocols & reports.
8. Coordination with cross-functional teams to complete the assigned work on time and data review.
9. Responsible for reviewing scientific experiments as per project requirements in an analytical laboratory catering to large molecule process development.
10. Providing the exact root cause for the issues and performing why-why analysis to understand the challenges
11. Review of Quality Assurance procedures in EDMS.
12. Contributing to development procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity & quality standards.
13. Providing the exact root cause for the issues and performing why-why analysis to understand the challenges
14. Review and implementation of cross-deployment of CAPAs across Development OUs.
15. Support for facing Customer audits and their related compliance.
16. Support for handling customer queries related to quality & compliance with Development OUs.
17. Overall adherence to safe practices and procedures of oneself and the teams aligned
18. Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace.
19. Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace.
20. Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self
21. Compliance with Syngene quality standards and Data integrity policies always.
22. Hold self-accountable for the achievement of safety goals

The Successful Applicant 

1. A minimum of 10 -15 years of experience in the pharmaceutical industry in Analytical Method development and Quality Control in large molecules and Biopharmaceuticals, with at least 5- 10 years of testing experience.
2. Proven track record of successfully managing and leading respective time.
3. Sound knowledge of analytical techniques, such as the characterization of large molecules, CE, RCE, GEL electrophoresis, HPLC, SEC-MALS, Bioassay, and plate-based techniques.
4. Sound knowledge of Guidelines such as ICH, USP etc
5. Strong understanding of regulatory requirements
6. Excellent communication, Interpersonal and problem-solving skills
7. Ability to work effectively with cross-functional teams and OU’s.
8. Technology Transfer/ Method Transfer from development to QC lab
9. Knowledge of setting acceptance criteria for method validation and transfers. Ability to Handle method transfer and data review as part of the transfer.

 Syngene Values 

All employees will consistently demonstrate alignment with our core values 

•  Excellence
•  Integrity
•  Professionalism 

Experience

• 10 -15 years of relevant experience

 Skills and Capabilities 

• Team player, Result-oriented and focused. 

Education 

• Master’s degree in Pharmacy and, Master’s in Biotechnology are both preferable

Equal Opportunity Employer 

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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.