Apply now »

Title:  Deputy Manager - Bioanalytical Research Lab

Date:  21 Feb 2025
Job Location:  Bangalore
Pay Grade: 
Year of Experience: 

 

JOB DESCRIPTION

 

Designation: Study Director/ Group leader/ Manager, Small Molecule Bioanalytical Laboratory, Clinical Development

Job Location: Bangalore, India

Reporting to: Head of Bioanalytical Laboratory

Job Grade: Level 7-II

 

The Company

 

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

 

The Role

 

The Bioanalytical Study Director/ Group Leader/ Manager is a pivotal role responsible for the conduct of comprehensive bioanalytical studies aimed at the quantification of small molecules using LC-MS/MS. The role demands a collaborative approach, working closely with the Bioanalytical team to analyze small molecules.

This role requires a proactive individual who can manage complex bioanalytical programs, ensure compliance with GxP regulatory standards, effectively communicate with clients and drive innovation within the team and lab. The role reports to the Head of Bioanalytical Laboratory and is a full-time position based out of Bangalore, India.

 

Key Responsibilities of the Role:

 

  • Working with a collaborative bioanalytical team of analyzing scientists for the development, validation and sample analysis for NCEs and Generics using the LC-MS/MS in support human studies.
  • Monitor the day-to-day activities conducted in the laboratory like method development, method validation and study sample analysis and also guiding the Project Leaders/Scientists/Research Associates.
  • Review method development and validation protocols, method validation reports, Study sample analysis protocol and Bioanalytical reports.
  • Ensure regulatory compliance across all bioanalytical programs, adhering to GLP/ GCP.
  • Ensure the technical compliance of programs by adhering to latest guidelines and white papers, maintaining high-quality deliverables and adherence to project timelines.
  • Independently manage studies and team, from executing studies to technical data review, analysis, and interpretation using advanced software tools.
  • Engage in technical forecasting, troubleshooting, client interactions, and strategic planning to ensure the successful execution of programs.
  • Work collaboratively across various functions within the laboratory and departments within Syngene - BD, Quality, Logistics, etc.
  • Participate in cross-functional project meetings to represent bioanalytical research services.
  • Oversee performance management and assessment of reporting staff, fostering a culture of excellence and continuous improvement.

 

 

Education and Experience

 

Education

 

Masters or PhD in Pharmaceutical Sciences from a reputed university.

 

Industry Experience

 

  • Minimum of 12 years of direct experience in small molecule bioanalysis, with a strong focus on LC-MS/MS based assays.
  • Demonstrated success in regulatory audits and dossier submissions related to bioanalytical studies.
  • Experience in a GCP/GLP bioanalytical laboratory

 

People leadership experience

 

Proven ability in leading, developing and managing teams

 

Exposure and experience

 

Experience with working for a Small Molecule Bioanalytical CRO lab will be an added advantage.

Experience with developing and validating LC-MS/MS methods for large molecules will be an added advantage.

Hands-on experience on Watson LIMS will be an added advantage.

 

 

Core competencies required for the role

 

  • Scientific:
    • Brings a creative and an innovative advantage to projects
    • Is curious, eager to learn and make a difference
    • Thinks scientifically and understands the problem statement in assigned programs/assays
    • Understands the MOA of the drug, the patient population and the related assay strategy
    • Publishes posters, papers and articles regularly
  • Technical
    • Conducts/plans experiments without errors and gaps
    • Reports/analyzes data punctually and communicates effectively
    • Troubleshoots and investigates logically (is able to defend the logic behind experimental results)
    • Is able to forecast risks and make mitigation plans ahead of time
    • Has good organizational, project management and client engagement skills
  • Documentation
  • Records data as per ALCOA++ policy
  • Pays attention to detail
  • Is punctual in responding to QC and QA reports
  • Displays minimal audit finding index
  • Writes clearly and concisely with English skills at >B+

 

 

 

 

 

 

 

 

 

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.

 

Pls visit us at https://syngeneintl.com/ to know more about us and what we do.

Apply now »