16 Bioanalytical Jobs

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department: Bioanalytical- Protiens & Biosimilars Designation: Research Associate Job Location: Ahmedabad (Gujarat) Education: M.Pharm/B.Pharm or M.Sc. Experience: 0 to 2 years CTC Range: 3 to 4 Lacs Key Responsibilities: Design and execute experiments to assess the PK and immunogenicity of therapeutic compounds using a variety of assays and methodologies. Develop and validate bioanalytical methods for the detection and quantification of anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Collaborate with cross-functional teams to plan and conduct immunogenicity studies, ensuring compliance with regulatory guidelines. Analyze and interpret data, generate scientific reports, and present findings to internal teams and external stakeholders. Stay up-to-date with the latest advancements in immunogenicity bioanalysis and contribute to the development of innovative approaches. Maintain laboratory equipment, ensure data integrity, and adhere to quality control and safety protocols. Participate in regulatory submissions and assist in interactions with sponsor audits as needed. COMPETENCIES Communication Work Ethic Organizational Culture fit Accountability

The Position Organization : - Jubilant Biosys Designation & Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience. Experience in a drug discovery industry/ CRO in DMPK department. Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.

" The Position Organization : - Jubilant Biosys Designation Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience.

Walk-In - Trainee CRA(Males) - B.Pharm / M.Pharm Freshers - Vimta Labs Greetings from Vimta Labs Ltd! We have openings for Freshers (Males only) in Clinical Research at Vimta Labs. Details of the job: Qualification: B. Pharm / M. Pharm Experience: Freshers No. of Positions: B. Pharm (5), M. Pharm (5) Job Location : Vimta Labs, Cherlapally CTC: 2.24 to 2.51LPA Gender: Only Male as this includes Night Shifts as well. Interested candidates can directly walk in to our office. Walk-In Date: 13th May (Tuesday) - 15th May (Thursday) Time: 10 AM to 11AM Interview Venue: Vimta Labs Ltd, IDA Cherlapally, Hyderabad Telangana 500051 Contact: Keerthana 9160712930

Development & Validation of Bioanalytical Method, Analysis of samples PK, BA/BE Studies, Preparation of reports. Should have experience in sensitive assays of drugs from biological matrix, Analysis based on LC-MS/MS Liquid handling system, ICP-MS Required Candidate profile Candidates must have experience in Bioanalytical department. MSc (Analytical, Org, Bioanalytical), M/Pharma, PhD in chemistry or Pharmaceuticals Science. Ready to work in first and second shift Perks and benefits 5 Days week, Bus Facility, Birthday Leave, 28 PL

Production: Execute production batches, ensure GMP, manage documentation QA: Ensure cGMP, Issuance and retrievals and manage records. QC: Analyze biopharma samples & maintain Documentation R&D: Prepare stocks and buffers, extract proteins & analyze.

MD/MV Roles and Responsibilities:- MD/MV group does assay method development and validation for various drug and their metabolites in biological fluids like plasma serum or urine by using LC/MS/MS. During method validation precision, accuracy, stability of drug/metabolite in biological fluid as well as after extraction is evaluated. The validated methods are then followed for the analysis of subject samples analysis for doing bioequivalence study.

Review Validation protocol, Chromatography Raw Data, Validation, Study Report, BA Report, in process report, responsible for providing response to QA. Required Candidate profile knowledge of Bioanalytical Data Review Prefer Ready to work in first and second shift MSc ,M.Pharma / B.Pharma with Bioanalytical data review experience will prefer. Perks and benefits 5 Days week, Bus Facility, Birthday Leave, 28 PL

Role & responsibilities Working with a collaborative Bioanalytical team on large molecule analysis for established assays and working on novel analytical platforms and ideas for PK/TK, PD (Biomarkers), ADA and Nab (Cell based and non-cell based). Ensure regulatory compliance across all bioanalytical programs, adhering to GLP & GCLP standards for method development, transfer, validation, and sample analysis for biologics. Ensure the technical compliance of programs by adhering to latest guidelines and white papers, maintaining high-quality deliverables and adherence to project timelines. Independently manage studies and team, from executing studies to technical data review, analysis, and interpretation using advanced software tools. Engage in technical forecasting, troubleshooting, client interactions, and strategic planning to ensure the successful execution of programs. Work collaboratively across various functions within the laboratory and departments within Syngene - BD, Quality, Logistics, etc Preferred candidate profile Minimum of 5 years of direct experience in large molecule bioanalysis, with a strong focus on ligand binding assays, biological assays, and cell-based assays. Demonstrated success in regulatory audits and dossier submissions related to bioanalytical studies. Experience in a GLP/GCLP bioanalytical laboratory. Perks and benefits

MD/MV group does assay method development and validation for various drug and their metabolites in biological fluids like plasma serum or urine by using LC/MS/MS. During method validation precision, accuracy, stability of drug/metabolite in biological fluid as well as after extraction is evaluated. The validated methods are then followed for the analysis of subject samples analysis for doing bioequivalence study. Candidates must experience in MD-MV onto LC/MS/MS for drugs and their metabolites in various biological fluids. Well versed in operating and trouble shooting LC/MS/MS instruments. Well versed in literature search, basic computer knowledge and MS-office. Aware of recent trends in regulated bioanalysis and regulatory guidelines Perform the extraction of samples using wet chemistry. Centrifuges, evaporators, freeze specimens as required. Performs aliquots of samples for wet chemistry. Performs wet chemistry according to study protocol guidelines and/or SOPs. Completes QC sheets and makes log book entries as required by protocol and/or SOP. Operate HPLC, LC/MS/MS and ICP-OES; troubleshoots problems and performs minor repairs

We are seeking an experienced Clinical Research Project Leader to oversee bioanalytical projects within our clinical research division. The ideal candidate will have 8-15 years of experience in analytical methods and bioanalytical research, demonstrating a strong understanding of regulatory requirements and industry best practices. Key Responsibilities: Project Management: Lead bioanalytical projects from initiation to completion, ensuring adherence to timelines, budgets, and quality standards. Develop project plans, manage resources, and coordinate cross-functional teams. Analytical Expertise: Utilize extensive knowledge of analytical techniques (such as LC-MS/MS, HPLC, and others) to guide bioanalytical method development, validation, and sample analysis. Ensure compliance with relevant regulatory standards (FDA, EMA, ICH). Collaboration: Work closely with clinical operations, regulatory affairs, and other departments to ensure seamless integration of bioanalytical activities within clinical trials. Facilitate communication between internal teams and external partners. Data Analysis Reporting: Oversee data analysis and interpretation of bioanalytical results. Prepare and review study reports, ensuring accuracy and compliance with regulatory requirements. Quality Assurance: Implement and maintain quality control processes to ensure the integrity and reliability of bioanalytical data. Participate in audits and inspections as required. Mentorship: Provide guidance and mentorship to junior team members, fostering a collaborative and innovative work environment. Continuous Improvement: Identify opportunities for process improvements in bioanalytical workflows. Stay updated on industry trends and advancements in analytical techniques.

Designation: Senior Research Associate/ Executive/ Analyst Job Location: Bangalore, India Reporting to: Group Leader of Bioanalytical Research 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. Syngenes 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 Research Associate/ Executive/ Analyst for the Small Molecule Bioanalytical Laboratory is a technical role responsible for conducting BA/BE studies 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 into the Project Leader / Group Leader, 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 sample processing for method development, method validation and study sample analysis as per the protocol in compliance with SOPs, STPs. Prepare STP, MV protocol and study sample analysis protocol. Coordinate with maintenance department for any problems related to utilities and equipment / instrument (e.g. LC-MS/MS, HPLC, etc) failures. Document data generated, entries in official documents. Ensure all studies adhere to regulatory guidelines and expectations set by GCP/ GLP. Participate in all discussions on project-specific scientific details. Education and Experience: Education: Masters in Pharmaceutics or other related life sciences from a reputed university. Industry Experience: Minimum of 1 years of experience in regulated small molecule bioanalysis Hands-on experience in small molecule regulated bioanalytical experiments 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 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 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.

Job Description :- QC Executive / Sr. Executive Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of all raw materials supplied by these vendors for every batch. We do in-house stability studies to make sure our products last the full shelf life and give the best results to our customers. Our goal is to provide our customers with nutraceutical products that promote health and wellness, and we are committed to using science-backed ingredients and formulations to achieve this goal. We are also committed to continuous innovation and improvement and are always looking for new ways to enhance our products and processes. Benefits Provided: 1 Free Air-Conditioned Transportation to the Factory 2 Paid Leave 3 Tea/Coffee & Canteen Facility 4 Accident Insurance 5 Provision for Bonus & Gratuity 6 Training programs for professional advancement 7 Progressive work environment conducive to personal and professional growth Job Title :- QC Executive / Sr. Executive Role & Responsibility: 1.To follow and ensure Good Laboratory Practices. 2.To perform the work according to work allotment. 3.To follow good documentation practices while making entries in Documents and records. 4.Make sure that materials are appropriately tested and results are reported. 5.To perform the Initiation and review of any change related to the department. 6.Make sure that deviations and Out of Specification Investigation are investigated and solved it with CAPA. 7.To perform the Preparation and review of all SOPs related to department, Specification and test procedures. 8.Preparation and execution of validation protocol for method validation and Analyst validation. 9.SOP Review, revision and Harmonization. 10.To perform the new products analysis method, review and arrange for necessary Corrections in test procedures. 11.To perform the Analytical method, transfer activity and report protocol review. 12.Arranging AMC of Instrument and servicing. 13.To perform the Instrument spare procurement and maintenance. 14.To Review of periodic calibration of Instruments. 15.Reference Standard procurement and management. 16.Monitoring the activity of working standard preparation and managements. 17.In- house training of Analysis and training of corporate training modules. 18.Review Analyst Qualification/ certification. 19.Departmental correspondence, Internal and external Audit compliance action. 20.Co-ordination with maintenance Dept. for QC Dept. utilities and its Maintenance. 21.To Review Qualification of Laboratory Instruments Equipment. 22.Handling Change control, OOS, OOT, Incident and deviation & CAPA. 23.Monitoring stability sample analysis, Microbiology Lab record review. 24.To check pharmaceutical addendum & supplement to make necessary amendment in the specification, whenever change in the Pharmacopoeia is observed. 25.Co-ordination for SCM related activity with IT and QA. 26.Storage of Laboratory data & records. 27.Instrument Data back up, and software users rights. 28.Arranging for outside testing and calibrations and its report Review. 29.To ensure the Approval and Rejection of Raw Material, Packing Material & Intermediates products. 30.Review of analytical results/data of in-process. Intermediate, water analysis finished API and issue COA for each batch of API. 31.Trouble shooting of the QC Instruments 32.If any additional responsibility assigned by senior. 33.To ensure all QC staff do the performance under GLP 34.Any additional job responsibilities as assigned by HOD. Department :- Quality Control Number Of Positions :- 01 Experience :- 3 to 8yrs Employment Type :- Full Time, Permanent Education UG: B.SC in Any Specialization PG : M.SC in Any Specialization Compensation :- As per Industry norms & experience Key Skills :- QC, UV, HPLC, ADL, Analytical, Method Development, Wet Analysis, PH Meter, GLP, Stability Analysis, SOP Review

Role & responsibilities Development and validation of bioanalytical methods using LCMS and other sophisticated instruments. Routine calibration of the instruments. Strong basic knowledge about Analytical instruments of LCMS, HPLC, HPTLC, GC-MS and other instruments. Good understanding of GLP and documents thereof. Knowledge of USFDA guidelines. Excellent communication skills & co-ordination among all the team members. Should possess good interpersonal and management skills Accountable for the whole group productivity in terms of number of samples, analysis, quality, quantity timelines better Turn Around Time (TAT) improvement Preferred candidate profile The candidate should have 1-4 years of experience in Bioanalytical Lab.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for monitoring, auditing and assuring the quality of operational aspects of the Facility according to established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements with support of auditors & other senior members. Job Responsibilities Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable. Performs audits (both project and non-project related) to assure the compliance to GCP/ GLP, SOPs, regulatory requirements of the following departments wherever applicable; Bio analytical Operations, Clinical Operations Department, Pharmacokinetic Unit, Quality Assurance Unit, and Other general divisional operations. Conducts in process surveillance (both project and non-project related) to assure ongoing compliance of the Bio analytical Operations/Clinical Operations/others Department as applicable. Prepares QA audit reports for all the above audits/surveillances performed. Conducts appropriate follow-up and take to completion any unresolved issues as a result of audit findings. Performs audit / review of software validation packages and IQ/OQ documents for systems used within the facility. Assists in the formal training of new and existing QA staff members to both QA and facility audit and procedures. Revise, implements, and maintains records of standards Operating procedures and additional relevant documents for the facility. Assists in Internal Audits whenever required. Reports to QA Management with respect to the operational status and disposition of all matters relating to the operations in the QA unit. Performs all work in accordance with all established regulatory and compliance and safety requirements. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Minimum Bachelor Degree holder in Science or Pharmacy. Knowledge, Skills and Abilities Knowledgle on current Guidelines like ICH Guidlines ,GCP and GLP for BA/BE studies Technical skills on LIMS, EP and Analyst software. Ability to perform audits in accordance to GDP, GLP and GCP and other requlatory requirements. Experience Minimum 2-4 years Experience in Regulated Industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Under supervision of reporting manager developing, validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applying the assay for the analysis of drugs and metabolites in biological fluids. Job Responsibilities Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre s, Standard Operating Procedures and in a consistent manner with current regulatory (DCGI- CDSCO, TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations. To work with the assigned project lead for Bioanalytical method development, Bioanalyitcal Method validation and Routine batch sample analysis (RBSA). Involves in preparation of project specific solutions and sample preparation. Documents all the work and results of all assignments as required. Verifies and saves acquired results in Chromatography Data acquisition systems, when required. Performs Laboratory Investigation, when required. Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems. Performs raw data compilation, assists in project wrap-up. To ensure lab work area cleanliness. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Minimum Bachelor Degree holder in Pharmacy or Masters Degree in Science. Knowledge, Skills and Abilities Good knowledge of GLP requirements. Good skills in MS Office. Good in Communication skills. Flexible to work Strives to drive projects related to Bioanalytical effectively. Experience Minimum 2-4 years of experience in Bioanalytical. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.