We are seeking a meticulous and motivated QA Analyst to join our team. The QA Analyst will be responsible for ensuring the quality and reliability of our systems and processes through comprehensive audits, testing, and compliance with regulatory standards. The ideal candidate will have a strong attention to detail, excellent communication skills, and the ability to work collaboratively in a dynamic environment. Key Duties and Responsibilities: Perform Quality Assurance Audits: Conduct system process audits to identify inconsistencies and areas for improvement. Quality Standards Development: Develop, review, and update quality standards to align with industry best practices. Testing Processes: Create, update, and evaluate test cases; contribute to both manual and automated testing efforts to ensure optimal system performance. Documentation: Develop, update, and maintain software documentation, standard operating procedures (SOPs), validation documentation, and other technical materials. Regulatory Compliance: Ensure adherence to relevant regulatory requirements, including but not limited to CSV, 21 CFR Part 11, EU regulations, GxP, and GMP standards. Skills and Qualifications: Quick learner with the ability to adapt to new tools and processes. Strong verbal communication and coaching skills. Excellent written communication skills for clear and concise documentation. Proven ability to work effectively in a team environment. Goal-oriented with a focus on achieving the mission and vision of the organization. Exceptional time management skills to prioritize tasks and meet deadlines. Flexible working approach, capable of adapting to changing project requirements and timelines. Preferred Experience: Experience with manual and automated testing tools. Familiarity with quality assurance frameworks and methodologies. Knowledge of regulatory compliance standards in relevant industries.
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!
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.
Job Overview: We are seeking a skilled and passionate Android App Developer to join our dynamic team. As an Android Developer, you will play a crucial role in designing, coding, testing, and debugging mobile applications for Android operating system. Responsibilities Collaborate with the founding team to design and develop the Android application from the ground up. Implement user interfaces and features that provide an exceptional user experience. Stay up-to-date with the latest industry trends, technologies, and best practices to continuously improve our mobile application. Participate in code reviews and provide constructive feedback to maintain code quality and consistency. Unit-test code for robustness, including edge cases, usability, and general reliability Work on bug fixing and improving application performance. Requirements and Skills Around 2 years of hands-on experience working as an Android Developer BS/MS degree in Computer Science, Engineering or a related subject. Have published at least one Android app on Google Play Store Proven experience in Android app development, preferably in a startup environment. Proficiency in Kotlin . Experience with Android SDK . Experience with Google Maps and Firebase . Strong knowledge of Android UI design principles, patterns, and best practices Working knowledge of the general mobile landscape, architectures, trends, and emerging technologies. Understanding of Android Architecture , Framework , Core Java , Android Studio IDE , Android Debugger . Familiarity with Agile development methodologies Experience with integrating third-party libraries and APIs Collaborate with cross-functional teams Experience with version control systems, such as Git Solid understanding of the full mobile development life cycle. Ability to work independently and collaboratively in a fast-paced startup environment. Excellent problem-solving and communication skills. Bonus Previous start-up experience
Job Summary We are seeking a skilled In Vitro Statistician with 2-7 years of experience to support our research and development teams in statistical analysis of in vitro studies. The ideal candidate will be responsible for designing experiments, analyzing data, and providing statistical insights to support decision-making in pharmaceutical, biotechnology, or life sciences research. Key Responsibilities: Design, develop, and analyze in vitro study experiments, ensuring statistical rigor and accuracy. Apply appropriate statistical models and methodologies for data interpretation. Work closely with scientists, biologists, and researchers to provide statistical guidance in study design and result evaluation. Utilize statistical software (e.g., SAS, R, JMP, or Python) to conduct data analysis, visualization, and reporting. Validate and verify data integrity, ensuring compliance with regulatory guidelines (FDA, ICH, GLP). Develop and review statistical analysis plans (SAPs), study protocols, and technical reports. Support regulatory submissions by preparing statistical documentation and reports. Stay updated with the latest statistical methods and best practices in in vitro research. Required Qualifications & Skills: Master’s or Ph.D. in Statistics, Biostatistics, Bioinformatics, or a related field. 2-7 years of experience in statistical analysis of in vitro studies, preferably in the pharmaceutical, biotechnology, or life sciences sector. Strong knowledge of experimental design, regression models, ANOVA, DOE, and multivariate analysis. Proficiency in statistical software (SAS, R, JMP, Python, or equivalent). Experience with data visualization, trend analysis, and predictive modeling. Understanding of regulatory requirements and compliance standards (FDA, ICH, GLP). Excellent communication skills to present findings to cross-functional teams. Strong problem-solving skills and attention to detail. Preferred Qualifications: Experience in bioassays, pharmacokinetics, biomarker analysis, or toxicology studies. Familiarity with machine learning and AI-based statistical modeling. Knowledge of clinical and preclinical statistical applications.
Job Summary We are seeking a skilled In Vitro Statistician with 2-7 years of experience to support our research and development teams in statistical analysis of in vitro studies. The ideal candidate will be responsible for designing experiments, analyzing data, and providing statistical insights to support decision-making in pharmaceutical, biotechnology, or life sciences research. Key Responsibilities: Design, develop, and analyze in vitro study experiments, ensuring statistical rigor and accuracy. Apply appropriate statistical models and methodologies for data interpretation. Work closely with scientists, biologists, and researchers to provide statistical guidance in study design and result evaluation. Utilize statistical software (e.g., SAS, R, JMP, or Python) to conduct data analysis, visualization, and reporting. Validate and verify data integrity, ensuring compliance with regulatory guidelines (FDA, ICH, GLP). Develop and review statistical analysis plans (SAPs), study protocols, and technical reports. Support regulatory submissions by preparing statistical documentation and reports. Stay updated with the latest statistical methods and best practices in in vitro research. Required Qualifications & Skills: Master’s or Ph.D. in Statistics, Biostatistics, Bioinformatics, or a related field. 2-7 years of experience in statistical analysis of in vitro studies, preferably in the pharmaceutical, biotechnology, or life sciences sector. Strong knowledge of experimental design, regression models, ANOVA, DOE, and multivariate analysis. Proficiency in statistical software (SAS, R, JMP, Python, or equivalent). Experience with data visualization, trend analysis, and predictive modeling. Understanding of regulatory requirements and compliance standards (FDA, ICH, GLP). Excellent communication skills to present findings to cross-functional teams. Strong problem-solving skills and attention to detail. Preferred Qualifications: Experience in bioassays, pharmacokinetics, biomarker analysis, or toxicology studies. Familiarity with machine learning and AI-based statistical modeling. Knowledge of clinical and preclinical statistical applications.
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.
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.
You are a meticulous and motivated QA Analyst responsible for ensuring the quality and reliability of systems and processes through audits, testing, and compliance with regulatory standards. Your strong attention to detail, excellent communication skills, and ability to work collaboratively in a dynamic environment are key assets. Your main responsibilities include conducting system process audits to identify inconsistencies, developing and updating quality standards, creating and evaluating test cases, and ensuring regulatory compliance. You will also be responsible for developing and maintaining software documentation, SOPs, validation documentation, and other technical materials. To excel in this role, you should be a quick learner adaptable to new tools and processes, possess strong verbal and written communication skills, work effectively in a team environment, and have exceptional time management skills to prioritize tasks and meet deadlines. A goal-oriented mindset focused on achieving the organization's mission and vision, as well as a flexible working approach to adapt to changing project requirements, are also required. Preferred qualifications include experience with manual and automated testing tools, familiarity with quality assurance frameworks and methodologies, and knowledge of regulatory compliance standards in relevant industries.,