Project Lead Bioresearch Laboratory

JOB DESCRIPTION

Designation: Bioanalytical Manager/ Project Leader Small Molecule Bioanalytical Research Laboratory Clinical Development

Job Location: Bangalore India

Reporting to: Group Leader of Small Molecule Bioanalytical Laboratory

Job Grade: Level 8-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. Syngenes 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 Manager/ Project Leader for the Small Molecule Bioanalytical Laboratory is a technical leadership role responsible for overseeing studies conducted in the laboratory. Job responsibilities include performing critical method development and validation programs technical and regulatory compliance of all studies.

This role requires an individual with a robust background in pharmaceutics or other related life sciences coupled with extensive experience in the bioanalytical field particularly within small molecule bioanalysis.

This role demands an individual with a strong commitment to compliance integrity and excellence in bioanalytical research particularly in small molecule analysis. The role reports to the Group Leader/ HOD Small Molecule Bioanalytical Laboratory and is a full-time position based out of Bangalore India.

Key Responsibilities of the Role:

• Perform the bioanalytical work including method development method validation and study sample analysis as per the protocol in compliance with SOPs STPs.
• Guide the Scientist / Research Associates as and when required to execute method development / method validation / study sample analysis experiments.
• Coordinate with maintenance department for any problems related to utilities and equipment / instrument (e.g. LC-MS/MS HPLC etc) failures.
• Review data generated entries made in official documents and analytical results.
• Coordinate with QA personnel for study-based audits.
• Coordinate with documentation personnel and reporting writing team for preparation of MV report and bioanalytical report.
• Ensure all studies adhere to regulatory guidelines and expectations set by GCP/ GLP.
• Conduct routine reviews of method development transfer validation and sample analysis data and reports ensuring high-quality deliverables.
• Participate in all discussions on project-specific scientific details.
• Demonstrate high levels of leadership and accountability towards agreed goals.
• Oversee performance management and assessment of reporting staff fostering a culture of excellence and continuous improvement.

Education and Experience

Education

Masters or PhD in Pharmaceutics or other related life sciences from a reputed university.

Industry Experience

• Hands-on experience in small molecule regulated bioanalytical experiments
• Experience in scientific technical troubleshooting and guiding high performing small molecule teams

People leadership experience

Proven ability in managing and developing teams

Exposure and experience

Experience with working for a Bioanalytical CRO lab 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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