The Bioanalytical Analyst and Senior Analyst will support bioanalytical studies in the clinical research domain, focusing on bioanalytical method development, validation, and sample analysis. The candidates will contribute to the execution of bioanalytical projects in compliance with GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and applicable regulatory requirements. Senior Analysts will have more supervisory and project leadership responsibilities. Key Responsibilities Analyst I/II (3-5 Years of Experience) Bioanalytical Method Development: Assist in developing and optimizing bioanalytical methods, including LC-MS/MS, HPLC, and other analytical techniques. Sample Preparation: Conduct bioanalytical sample preparation, including extraction techniques such as protein precipitation, liquid-liquid extraction, and solid-phase extraction. Method Validation: Assist in bioanalytical method validation following regulatory guidelines (FDA, EMA) for clinical trials. Sample Analysis: Perform bioanalysis of clinical samples such as plasma, serum, urine, etc., ensuring accuracy, precision, and reliability of results. Documentation: Maintain accurate and complete documentation, including lab notebooks, SOPs, protocols, and reports. Compliance: Follow Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) to ensure data integrity. Data Analysis: Process raw data and generate reports for study documentation and regulatory submission. Equipment Maintenance: Operate and maintain laboratory equipment, ensuring proper calibration and troubleshooting as necessary. Senior Analyst I/II (5-8 Years of Experience) In Addition To The Responsibilities Mentioned For Analyst I/II Project Management: Lead and manage bioanalytical projects, ensuring timely and accurate delivery of results. Supervision: Mentor junior analysts and provide technical guidance to ensure best practices in bioanalytical processes. Regulatory Compliance: Ensure all bioanalytical activities are compliant with regulatory standards (FDA, EMA, etc.) and maintain audit readiness. Client Interaction: Collaborate with sponsors, clients, and cross-functional teams to meet project goals and expectations. Method Troubleshooting: Troubleshoot bioanalytical methods and equipment issues, providing solutions to improve performance. Reporting & Review: Review data analysis reports generated by junior team members, ensuring accuracy and regulatory compliance. Quality Control: Oversee and implement quality control measures for all bioanalytical processes, including internal audits. Show more Show less

Job Summary We are looking for a versatile Analyst focusing on our In Vitro segment with experience in one or more of our in vitro services, such as IVRT, IVPT, in vitro bioequivalence (BE) studies, BCS biowaivers, enteral feeding tube studies, or in vitro statistical analysis. While expertise in all these areas is not required, candidates should have a strong foundation in in vitro techniques, regulatory guidelines (eg: FDA, EMA), and data interpretation to support pharmaceutical product development. Key Responsibilities Conduct or support one or more of the following: In vitro release testing (IVRT) and in vitro permeation testing (IVPT) for pharmaceutical formulations. In vitro bioequivalence studies and BCS biowaiver studies as per regulatory standards. Enteral feeding tube studies to assess drug administration compatibility. Analysis and interpretation of data from in vitro studies, applying statistical methods where required. Ensure compliance with FDA, EMA, ICH, and USP guidelines in laboratory procedures. Prepare and review study protocols, scientific reports, and regulatory documentation. Collaborate with cross-functional teams, including regulatory affairs and bioanalytical scientists. Maintain laboratory equipment, follow SOPs, and ensure GLP/GMP compliance. Basic understanding of statistical analysis for in vitro studies is a plus. Qualifications & Skills Education: Bachelor’s, Master’s or Ph.D. in Pharmaceutical Sciences, Biopharmaceutics, Analytical Chemistry, or a related field. Experience: At least 2 years of experience in any in vitro research area, preferably within a CRO or pharmaceutical company. Soft Skills Strong analytical and problem-solving abilities. Excellent written and verbal communication skills. Ability to learn quickly and adapt to new in vitro methodologies. Why Join Us? Work with a leading CRO specializing in diverse in vitro research areas. Gain exposure to multiple in vitro techniques and expand your expertise. Collaborative and growth-oriented work environment. If you are eager to develop expertise in in vitro research and contribute to high-impact pharmaceutical studies, we encourage you to apply! Show more Show less

The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findings meticulously, preparing detailed reports for management and regulatory bodies. Additionally, you will participate in audits and inspections to uphold quality standards. To excel in this role, you should hold a Bachelors/Masters degree in Life Sciences, Pharmacy, Chemistry, or a related field. With 2-6 years of experience in Quality Control/Quality Assurance within the pharmaceutical or biotech industry, you are expected to have a strong understanding of GLP, GCP, FDA, EMA, and ICH guidelines. Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation, along with excellent attention to detail and problem-solving skills, are essential. Effective communication and interpersonal skills are necessary to collaborate with cross-functional teams. Moreover, staying updated with regulatory changes and industry best practices will contribute to enhancing the organization's quality standards. Experience with bioanalytical, clinical, or preclinical study reviews, knowledge of electronic data capture (EDC), and the ability to handle multiple projects with tight deadlines are preferred skills for this role. Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) would be advantageous.,

Job Summary The Contract & Proposal (C&P) professional will be responsible for managing the end-to-end process of drafting, negotiating, and finalizing proposals and contracts related to bioanalytical services. This role bridges scientific understanding with commercial acumen, ensuring timely, compliant, and competitive proposals are delivered to clients and sponsors in alignment with business objectives. Key Responsibilities Collaborate with Business Development, Project Management, and Scientific teams to understand client requirements and scope of work. Prepare detailed technical and commercial proposals for bioanalytical services (e.g. PK/PD studies, method development & validation, sample analysis). Coordinate internal costing exercises and build accurate pricing models based on resource and timeline inputs. Draft, negotiate, and finalize various contract types (e.g., MSA, CDA, SOW, Work Orders) with clients. Review RFPs and RFIs, and prepare responses ensuring compliance with client guidelines and internal standards. Maintain a database of approved proposal templates, standard pricing modules, and contract clauses. Track proposal status, feedback, negotiations, and closure timelines in coordination with BD. Support audit and compliance documentation related to contracts and pricing. Ensure alignment with regulatory requirements (GLP/GCP), industry standards, and corporate policies in all documentation. Build strong relationships with external sponsors and internal cross-functional teams. Required Qualifications Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, or related field. 2–7 years of experience in C&P or Proposal Development roles in a Bioanalytical or Clinical CRO. Strong understanding of bioanalytical lab services, GLP/GCP compliance, and clinical study structures. Proficiency in MS Excel, Word, and PowerPoint; experience with CRM tools is a plus. Excellent communication, negotiation, and writing skills. Detail-oriented with strong analytical and time management skills. Preferred Attributes Experience dealing with international clients (US/EU/APAC) in a regulated environment. Ability to manage multiple proposals simultaneously with tight deadlines. Familiarity with regulatory frameworks (USFDA, EMA, DCGI) relevant to bioanalytical studies.

The Contract & Proposal (C&P) professional will be responsible for managing the end-to-end process of drafting, negotiating, and finalizing proposals and contracts related to bioanalytical services. This role bridges scientific understanding with commercial acumen, ensuring timely, compliant, and competitive proposals are delivered to clients and sponsors in alignment with business objectives. You will collaborate with Business Development, Project Management, and Scientific teams to understand client requirements and scope of work. Your responsibilities will include preparing detailed technical and commercial proposals for bioanalytical services such as PK/PD studies, method development & validation, and sample analysis. Additionally, you will coordinate internal costing exercises and build accurate pricing models based on resource and timeline inputs. In this role, you will draft, negotiate, and finalize various contract types (e.g., MSA, CDA, SOW, Work Orders) with clients. You will review RFPs and RFIs, and prepare responses ensuring compliance with client guidelines and internal standards. Maintaining a database of approved proposal templates, standard pricing modules, and contract clauses will also be part of your duties. Tracking proposal status, feedback, negotiations, and closure timelines in coordination with BD, as well as supporting audit and compliance documentation related to contracts and pricing, are crucial aspects of this role. Ensuring alignment with regulatory requirements (GLP/GCP), industry standards, and corporate policies in all documentation is essential. Building strong relationships with external sponsors and internal cross-functional teams is key to success in this role. Required Qualifications: - Bachelors or Masters degree in Life Sciences, Pharmacy, Chemistry, or related field. - 2-7 years of experience in C&P or Proposal Development roles in a Bioanalytical or Clinical CRO. - Strong understanding of bioanalytical lab services, GLP/GCP compliance, and clinical study structures. - Proficiency in MS Excel, Word, and PowerPoint; experience with CRM tools is a plus. - Excellent communication, negotiation, and writing skills. - Detail-oriented with strong analytical and time management skills. Preferred Attributes: - Experience dealing with international clients (US/EU/APAC) in a regulated environment. - Ability to manage multiple proposals simultaneously with tight deadlines. - Familiarity with regulatory frameworks (USFDA, EMA, DCGI) relevant to bioanalytical studies.,