Title:  Study Director-GLP

Designation: Deputy Manager

Job Location: Bangalore

Department: GLP-Physical Chemical Testing Laboratory

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose

To perform and manage the characterization, analytical method development, validation, and dose formulation analysis. Additionally, support in overseeing the Bioanalytical studies.

The role will involve conducting all work in compliance with applicable regulatory requirements and Good Laboratory Practice. Knowledge on Small and Large Molecule Bioanalysis is desirable, to handle shared responsibilities.

Key Responsibilities:  

• Develop and implement quality systems in coordination with Quality Assurance.
• Ensure studies comply with Good Laboratory Practice (GLP) principles.
• Operate and maintain analytical and ancillary equipment (HPLC/UHPLC, LCMS, Solo VPE, etc.).
• Ensure data integrity compliance with ALCOA+ principles.
• Manage study and facility deviations.
• Implement and adhere to best safety practices in the workplace.
• Collaborate with Test Facility Management, Quality Assurance Unit, Document Controller, Test Item Controller, and Archivist to conduct studies and manage the facility.
• Oversee calibration and maintenance of instruments/equipment to ensure compliance.
• Lead and manage a team of professionals, fostering a collaborative and productive work environment.
• Optimize processes to improve efficiency, reduce costs, and enhance quality.
• Plan, execute, and oversee analytical projects supporting toxicology and genetic toxicology studies.
• Identify opportunities for continuous improvement in laboratory practices and implement innovative solutions
• Develop and implement training programs to enhance the skills and knowledge of the team.

Educational Qualification:  

• M.Sc./ M. Pharm in Chemistry

Technical/Functional Skills:

• Experience in analytical studies. Knowledge and experience in and bioanalytical studies is desirable.
• Proficiency in handling analytical and ancillary instruments (GC, UPLC/HPLC, LCMS, Solo VPE, etc.).
• Ability to review study data, calibration, and maintenance records.
• Expertise in MS Office applications (Word, Excel, PowerPoint).
• Knowledge of regulatory requirements and guidelines (OECD, USFDA, EMEA, ICH, etc.).
• Strong leadership, communication, and interpersonal skills.
• Proficiency in project management, data analysis, and strategic planning.
• Ability to ensure compliance with industry standards and GLP requirements.
• Strong problem-solving skills for technical issue resolution.
• Ability to develop and implement strategies to enhance analytical capabilities and operational efficiency.
• Experience in handling client/regulatory audits
• Handle troubleshooting during the conduct of studies.
• Ability to identify potential risks and develop mitigation strategies
• Proficiency in technical writing for the preparation of reports, protocols, and standard operating procedures (SOPs)
• Familiarity with advanced analytical techniques and emerging technologies in the industry.
• Maintain effective communication with internal and external stakeholders to ensure alignment on project goals and timelines.

Experience:

• 12-14 years in the relevant regulated environment

Behavioral Skills:

• Good communication skill, both verbal and written.
• High level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
• Ability to work successfully in a dynamic environment.
• Ability to meet tight deadlines and prioritize work.
• Ability to develop new ideas and creative solutions.
• Ability to inspire and motivate team members to achieve their best performance and maintain high levels of engagement and morale.
• Skill in delegating tasks appropriately, empowering team members, and providing them with the autonomy and responsibility to excel in their roles.
• Skill in prioritizing tasks and managing time effectively to ensure that key objectives are met and adhere to the deadlines.

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.