Title: Project Leader - Bioanalytical Research Lab
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. 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 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
Master’s or PhD in Pharmaceutics or other related life sciences from a reputed university.
Industry Experience
- Minimum of 10 years of experience in regulated small molecule bioanalysis
- 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 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.