Bioanalytical Manager

JOB DESCRIPTION

Role: Bioanalytical Manager, Immunogenicity Research Laboratory

Job Location: Bangalore, India

Reporting to: HOD of Large Molecule Bioanalytical Laboratory

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 Manager for the Large Molecule Bioanalytical Laboratory is a technical leadership role responsible for overseeing studies conducted in the laboratory. Job responsibilities include directing study directors/principal investigators, role of a study director for critical method development and validation programs, technical and regulatory compliance of all studies, resourcing and team management.

This role requires an individual with a robust background in biochemistry, microbiology, or other biological sciences, coupled with extensive experience in biotech and bioanalytical fields, particularly within large molecule bioanalysis.

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

Key Responsibilities of the Role:

• Technical oversight and management of junior study directors/principal investigators working with immunoassay and cell-based methods for Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Biomarkers for biologics.
• Be a study director for critical method developments and validations.
• Ensure all studies adhere to regulatory guidelines and expectations set by GLP/GCLP, serving as the primary point of contact for study related regulatory questions.
• Guide the team on troubleshooting and provide technical and regulatory guideline support.
• Conduct routine reviews of method development, transfer, validation, and sample analysis data and reports, ensuring high-quality deliverables.
• Participate in project meetings with both Indian and international clients, and participate in all discussions on project-specific scientific details.
• Demonstrate high levels of leadership and accountability towards agreed goals.
• Participate in interviews and discussions, when needed, for team expansion.
• Work in a collaborative model with various functions within the laboratory and departments within Syngene, including Business Development (BD), Quality, and Logistics.

• Oversee performance management and assessment of reporting staff, fostering a culture of excellence and continuous improvement.

Education and Experience

Education

Masters or PhD in Biochemistry/ Microbiology/ other biological sciences from a reputed university.

Industry Experience

• Minimum of 10 years of experience in regulated (GLP/GCLP) large molecule bioanalysis
• Hands-on experience in large molecule regulated bioanalytical experiments
• Experience in scientific, technical troubleshooting and guiding high performing large molecule teams

People leadership experience

Proven ability in managing and developing teams

Exposure and experience

Experience with working for a Large Molecule 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 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.