Associate Principal Scientist - Analytical Services -Bioassay

Department: Analytical Services (Biologics)

Location: Hyderabad

About the Role

Daicel Chiral Technologies (India) Pvt. Ltd. is seeking a highly experienced and motivated Associate Principal Scientist - Bioassay to lead bioassay activities within the Analytical Services (Biologics) division. This leadership role involves managing a team of scientists, establishing advanced bioassay platforms, driving method development and validation programs, ensuring regulatory compliance, and serving as a key technical interface with clients.

The ideal candidate should possess extensive experience in Peptide and Monoclonal Antibody Bioassays. Experience in Oligonucleotides, Antibody Drug Conjugates (ADCs), and Immunogenicity Assays will be an added advantage

Required Qualifications

- M.Sc. / M.Tech/ M.Pharm in Biotechnology, Life Sciences or related discipline.
- PhD in Biotechnology, Biochemistry, Immunology, or related field

Required Experience

- 15+ years of relevant industry experience for M.Sc./M.Tech/M.Pharm in Biotechnology candidates OR 10+ years of relevant experience for PhD candidates.
- Hands-on expertise in biologics bioassays, particularly: Peptides, Monoclonal Antibodies (mAbs)
- Experience in Oligonucleotides, ADCs, and Immunogenicity assays is preferred.

Desired Technical Skills

- Cell-based Functional Assays, ELISA and Immunogenicity Assays, and Potency Bioassays
- Method Development & Validation
- Statistical Analysis of Bioassays
- SoftMax Pro and PLA Software
- Stability Studies and Forced Degradation Studies
- GMP / GLP / GDP Compliance
- Regulatory Documentation & Quality Systems

Desired Competencies

- Strong leadership and people management skills
- Excellent scientific writing and communication skills
- Client-facing and stakeholder management capability




- Analytical problem-solving and troubleshooting expertise
- Project management and multitasking abilities
- Strong quality and compliance mindset

Key Responsibilities:

Technical Leadership

- Lead and manage a team of scientists and analysts engaged in biologics bioassay projects.
- Establish new bioassay platforms and drive technology implementation.
- Lead feasibility studies, proof-of-concept (POC), method development, optimization, validation/verification, and method transfer activities.
- Oversee execution of cell-based assays, cell-free assays, ELISA, immunogenicity assays, potency assays, and batch release testing.
- Review and interpret bioassay data, prepare scientific reports, and ensure technical excellence.

Bioassay Development & Data Analysis

- Develop and validate bioassays for biologics including peptides and monoclonal antibodies.
- Evaluate assay performance, robustness, sensitivity, precision, accuracy, and specificity.
- Perform and review statistical analysis using SoftMax Pro and Parallel Line Analysis (PLA) Software
- Analyze dose-response curves, relative potency calculations, assay validity, and statistical assessments.

Quality & Regulatory Compliance

- Ensure compliance with cGMP, GLP, GDP, Data Integrity principles, and Quality Management Systems.
- Maintain compliance with ICH Q2(R2), FDA, EMA, WHO, CDSCO, and applicable regulatory guidelines.
- Review and approve SOPs, protocols, MOAs, reports, validation documents, and laboratory records.
- Lead OOS,



OOT, deviations, change controls, investigations, CAPA, and risk assessments.
- Support internal, client, regulatory, and FDA audits.

Client & Business Interaction

- Evaluate client requirements and technical queries.
- Prepare technical and commercial proposals.
- Participate in client discussions, teleconferences, and project finalization meetings.
- Provide scientific support and timely responses to client questions and audit observations.

Laboratory Operations & Team Management

- Allocate project activities and monitor team performance.
- Provide technical guidance, mentoring, and training to team members.
- Ensure effective laboratory operation and resource utilization.
- Coordinate cross-functional activities to meet project timelines.
- Report project status and department updates to Analytical Services leadership.

Secondary Responsibilities

- Inventory and laboratory consumable management.
- Equipment calibration and maintenance coordination.
- Environmental monitoring and laboratory compliance activities.
- LN2 monitoring, refilling, and inventory management.
- Temperature, humidity, and differential pressure monitoring.
- Biohazard waste management compliance.
- CO2 cylinder replacement coordination and laboratory housekeeping oversight.

Why Join Daicel?

- Chance to lead advanced biologics bioassay programs.
- Work with global clients and cutting-edge biologics platforms.
- Professional growth in a highly regulated and scientifically driven environment.
- Collaborative and innovation-focused culture.

How to Apply

Interested candidates meeting the above qualifications and experience criteria are encouraged to apply.

Email your updated resume to: [email protected]

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📌 Associate Principal Scientist - Bioassay (Telangana)
🏢 Daicel Chiral Technologies
📍 Telangana