69 Method Transfer Jobs

We are seeking a highly skilled Executive / Sr. Executive Quality Assurance with 8 to 10 years of experience in API / Bulk Drug Manufacturing . The role involves overseeing laboratory incidents, OOS/OOT investigations, analytical method validations, data integrity compliance , and ensuring adherence to GMP and regulatory standards . Key Responsibilities: Handle and review laboratory incidents, OOS (Out of Specification), OOT (Out of Trend), deviations, and root cause investigations . Review and monitor calibration schedules and records for critical analytical instruments (HPLC, GC, UV, IR, AAS, ICP-MS). Oversee analytical method validation, method transfers, and specification reviews in alignment with regulatory requirements. Provide training to QC teams on laboratory procedures, data integrity , and documentation practices . Conduct surprise lab audits/visits and proactively identify compliance gaps to ensure readiness for inspections. Ensure compliance with cGMP, ICH, and regulatory guidelines throughout QA operations. Eligibility Criteria: Education: B.Sc / M.Sc in Chemistry or related field. Experience: Minimum 8 to 10 years in pharmaceutical Quality Assurance (API / Bulk Drug). Preferred Candidates: Male candidates available for immediate joining .

As a Quality Control Laboratory Specialist, your primary responsibility will be to ensure compliance with Standard Operating Procedures (SOPs) and regulatory requirements within the laboratory. You will be required to provide training to QC Associates on SOPs and current regulatory standards based on review observations. Additionally, your role will involve reviewing a variety of analytical data including Finished, Intermediate, Raw Material, and Stability samples. It will be your duty to meticulously review electronic data and compare it with hard copies to guarantee the accuracy of the analytical results. You will also be responsible for examining Stability Protocols, schedules, data sheets, as well as master lists of instruments and equipment, along with their respective Qualification documents. Furthermore, you will play a crucial role in reviewing Preventive Maintenance and Calibration schedules, along with the Calibration data of all Analytical Instruments housed within the Quality Control laboratory. You will also be tasked with reviewing Method transfer/verification/validation protocols and reports, including the raw data, as well as evaluating Reference Standards/Working Standards and their respective Certificates of Analysis. In order to ensure the consistency of analytical trends, you will be expected to prepare quality comparison sheets for all dispatched materials. Your role will also involve reviewing monthly comprehensive assessment reports, laboratory errors, invalidations, and Analyst Qualification raw data. Additionally, you will need to conduct an audit trail review of all standalone instruments and Empower systems within the Quality Control department, as well as reviewing certificate of analysis documents. Key Competencies required for this role include excellent verbal and written communication skills, persuasiveness, strong inter-personal skills, adaptability, foresight, and a solid understanding of business processes. If you possess these competencies and are ready to take on the responsibility of maintaining quality standards within the laboratory, we encourage you to apply for this position.,

You will be joining a company committed to delivering high-quality pharmaceutical products and services, with a mission to enhance the quality of life through innovative healthcare solutions. The culture at Zydus revolves around collaboration, integrity, and excellence. As the ADL - Analytical Development Laboratory Executive/Senior Executive, your primary responsibility will involve method development, verification, and validation to ensure compliance with Pharmacopeial standards. You will also support various analytical activities within the department. Your key responsibilities will include method development, verification, and validation for Pharmacopeial standards, DMF updations, and other requirements within the department. Additionally, you will be involved in calibration and other analytical activities such as Engineering Batch and F&D Batch. You may also provide on-site or off-site support to Site-QCs for investigations or analysis. Evaluation and analysis related to Elemental Impurities and Nitrosamine Impurities Compliance, stability sample management, and coordination for resolving IT, Electrical, Civil, and other lab instruments breakdown issues will be part of your duties. Qualifications required for this role include a degree in B. Pharm / M.Sc. / M. Pharm with a minimum of 3-5 years of experience. You should possess skills in Method Development, Method Validation, and Method Transfer for Drug Substances and Drug Products. Additionally, you should be proficient in evaluating, analyzing, and preparing reports for Elemental Impurities compliance in Excipients, Drug Substances, and Drug Products. Experience with advanced analytical techniques and regulatory compliance is a preferred skill for this position. Zydus is an equal opportunity employer that values diversity and is dedicated to fostering an inclusive environment for all employees.,

Manage & guide team, coordinate with all concerned department, supervise method development/validation, review data/docs, oversee calibration, method transfers, customer calls & team training. Required Candidate profile M.Pharm/ M.Sc with team management skills in AR&D. Strong in method development/validation, data review, calibration, training juniors, client coordination.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. To carry out the sampling of all the materials according to Standard Operating Procedure (SOP). To ensure the status label on the material and transfer such material in the respective area. To ensure that all activities followed in accordance with the SOP. To perform the analysis as per the specification & standard test procedure and record the necessary results in respective documents for Raw Material/Packing material/In-process sample, Validation sample, finish products and other samples. To involved and support in investigation of failure of any material or product in case of any out of specification (OOS) or OOT or laboratory incident or non-conformity and take corrective and preventive actions. To prepare reagents and volumetric solution and standardize it. To check and verify standardization and preparation of reagents and volumetric solution. To raise and implement change control or document change request wherever necessary. To perform chemical analysis To assess the results of testing of Raw Material/Packing material/In-process sample, Validation sample, finish products and other sample to ensure alignment with standard operating procedure (SOP) and regulatory guidelines. To perform the calibration of analytical instruments. To follow and ensure Good Laboratory Practices (GLP), Good Documentation Practices and Good Manufacturing Practices (GMP) inside Quality Control. To ensure availability the working & impurities standards as per various pharmacopoeias. To assist Supervisor in preparation of SOP and give suggestions to improve system performance. To check, verify and review the calibration of all the analysis instruments whether performed as per the schedule. To check completion of method transfer successfully in coordination with Analytical Development Lab (ADL) Department. To make entry into LIMS. To ensure recording of all the data related to the testing online, on day-to-day basis and ensure traceability of the same. To work for lab readiness for audit and ensure compliance in Laboratory. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

You must have experience in analytical development or handling of oligonucleotides method development. Additionally, you should possess experience in characterization techniques related to oligonucleotides. In this role, you will be responsible for providing routine analysis support to the process development team for various projects. It is essential that you have good documentation skills in line with laboratory GMP practices and the ability to understand and adhere to current Good Manufacturing Practices. Your duties will include ensuring compliance with all quality audits, maintaining data integrity, and following ALCOA++ Principles. You will also be required to prepare and review method development reports, method validation protocols, and reports. Experience in method qualification activities is necessary for this position. As part of your responsibilities, you will work with the instruments assigned for analysis and be involved in their calibration. Collaboration with DQA/Plant QC for method transfer will also be expected. Any additional experience in characterization techniques of oligonucleotides and peptides will be considered advantageous. It is preferable that you have experience in amino acids analysis, SEC-MALS, DLS, CE, and other related techniques. Interpretation of characterization data is a crucial aspect of this role, and you should be capable of performing this task effectively.,

Role & responsibilities Perform the calibration and preventive maintenance of the instruments as per the respective schedules. Analysis of raw material / finished products / stability samples / Dissolution profiling for R&D/ Plant support. Analytical Method Development /Verification Assay, Related substances, Dissolution etc . Perform the determination of KF factor, Daily verification of Balances, pH meter, Milli-Q water system, Hot Air Oven, Refrigerator temperature monitoring. Develop/ optimize the analytical methods by Chemical/ instrument analysis Verify/ validate the analytical methods by Chemical/ instrument analysis Preparation / Revision of Specification and Method of analysis for Raw materials / Finished Product / Inactive / Excipients etc Appropriate documentation of results and calculations, preparation of SOPs, specifications and test methods. Interpret results, evaluate data, draw relevant conclusions and give timely feedback to concerned Departments. Analytical Technology transfer of analytical methods by Chemical/ instrument analysis Perform the Impurity standard/ working standard/ primary reference standards. Receiving and filling controlled copy of specifications / method of analysis / SOP / STP etc Operation of various software like Oasis LIMS, Q Edge TMS, Chromeleon etc Preferred candidate profile Qualification: B. Pharm / M.Pharm / M. Sc Experience: Minimum 2 years in HPLC Analysis Development and Validation Perks and benefits Mediclaim

1. Execute validation of analytical methods as per ICH guidelines 2. Method Verification 3. Method Transfer 4. Instrument Handling (HPLC,UV-Visible Spectrophotometer) 5. Documentation & Compliance 6. Audit Readiness & Regulatory Support Perks and benefits Bachelor's Accommodation and Travelling facility

Role Description: Quality control executive Location: Mil Laboratories Pvt. Ltd. 541, GIDC, Manjusar, Ta. Savli, Dist. Vadodara - 391775 Experience: 5 to 6 years Roles Responsibilities:- To perform all the testing related to RM, bulk, FP and stability samples To perform all the testing of packaging materials Handling of QMS documents like SOP, CAPA, repeat analysis, Deviation etc. To manage and lead the team To perform analytical method validation To prepare specifications for different materials New vendor approval Should have working experience of HPLC, GC, UV spectrophotometer, centrifuge etc. What will you need to be successful Preferred experience in sterile pharma plant. Extensive understanding of sterile and disinfectant products, GMP and GLP Should have faced and experienced regulatory audits Positive attitude, problem solving and time management hould have a knowledge of ICH guidelines and other standards Interested Relevant can share profiles to

As a member of the team, you will be responsible for core analytical method development and CMC activities related to Inhalation dosage forms. Your role will involve performing analytical tasks throughout the development process, including scale-up support, method validation, method transfer, release testing, stability testing, drug product characterization, E&L Study, In-vitro study, as well as routine analysis of inhalation dosage forms. You will conduct various tests such as assay, related compound analysis, APSD, DDU, and particulate matter analysis for inhalation dosage forms. The ideal candidate for this position should hold a degree in M. Pharm, M. Sc., or B. Pharm. Amneal is an equal opportunity employer committed to creating a diverse and inclusive workplace that values individuals from all backgrounds. The Human Resources team at Amneal plays a crucial role in partnering with all departments to ensure effective people management for current and future business needs. The team performs various key roles, including: - Executive Role: Providing expertise in all aspects of people management and offering strategic input into key business decisions. - Audit Role: Ensuring compliance with legal requirements and best practices in employment policies and procedures across the organization. - Facilitator Role: Collaborating closely with different departments to enhance their ability to achieve objectives through effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, and Health & Wellbeing. - Consultancy Role: Offering expert advice to the organization and managers on various aspects of workforce management, employee relations, and performance. - Service Role: Keeping the organization informed and prepared to address changes in employment matters, such as legislative updates and shifts in the labor market characteristics. Join us at Amneal and be part of a team that values diversity, inclusion, and excellence in people management.,

This role has been designed as ?Hybridwith an expectation that you will work on average 2 days per week from an HPE office, Who We Are Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work We help companies connect, protect, analyze, and act on their data and applications wherever they live, from edge to cloud, so they can turn insights into outcomes at the speed required to thrive in todays complex world Our culture thrives on finding new and better ways to accelerate whats next We know varied backgrounds are valued and succeed here We have the flexibility to manage our work and personal needs We make bold moves, together, and are a force for good If you are looking to stretch and grow your career our culture will embrace you Open up opportunities with HPE, Job Description Global Sales at HPE is about building the future We are redefining whats next and combining our legacy of innovation with a bold new goal to accelerate everything we do Our sales organization is comprised of 10,000+ professionals in sales, presales, service, and support functions Together with our partners, we deliver global, commercial, public sector & small/medium business customers throughout 11 geographies Were transforming businesses Join us redefine whats next for you, Job Family Definition Responsible for architecting solutions that will achieve customer business outcomes either within a specific technical domain, or across the broader company portfolio (hardware, software, services, and as a service offerings) in combination with all necessary third-party components (e g software and integration) Develops and articulates compelling, accurate, and relevant proposals and ensures customer's business and technical requirements are met Can be aligned to a specific area of technical expertise (e g , products, solutions, services) Provides technical expertise to sales teams and customers (through sales presentations, product/solution demonstrations, etc) aimed at gaining the customer mindshare within their domain These jobs focus on technical selling to customers/partners May be aligned to specific accounts based on business priority, Management Level Definition Contributions include applying intermediate level of subject matter expertise to solve common technical problems Acts as an informed team member providing analysis of information and recommendations for appropriate action Works independently within an established framework and with moderate supervision, Responsibilities What youll do: Develops and articulates compelling customer proposals, ensuring the customers business and technical requirements are met, Identifies and articulates key risks related to the respective scope, Provides work estimations as well as recommendations on sourcing models, Review customer proposals for accuracy, relevance, and competitiveness, ensuring customer enthusiasm and collaborating with senior colleagues in review processes as necessary, Offers input to address key end-customer IT trends, requirements, gaps, or unmet needs, Performs due diligence by ensuring technical design solutions work, meet customer workload needs, service level expectations, and are within budget, Develops and maintains awareness of leading-edge and emerging technologies, understanding these resources to find, both inside and outside of HPE, information regarding trends and standards, while also actively monitoring competitor offerings and activities, Creates and develops the implementation design of technical products, services, and solutions that address specific customer needs by participating in deep-dive discussions and leveraging a solid knowledge of customers' technical environment and a thorough knowledge of company's portfolio, Addresses customer questions and concerns regarding technical products, services, and solutions within a specific scope, Collaborates with internal and external partners to successfully transfer knowledge and deliver effective solutions to customers, Connect with key partners and stakeholders within an area of specialization and understand their capabilities, and limitations, supporting all partner enablement and initiatives as needed, Proactively build the pipeline by identifying opportunities (e g , enhancements, unmet or unrecognized needs, up-selling, and cross-selling opportunities) within the account, Supports the opportunity pipeline and help drive through the sales process to closure, Actively participates in sales forecast meetings and provides feedback to accelerate the sales lifecycle, Documents ongoing work (activities, tasks) throughout the sales cycle using specific tools and resources, sharing best practices with peers and partners to collaborate effectively, Develops a working relationship with the customer technical teams by understanding the customers ecosystem and how HPE's solutions can align to the ecosystem and deliver value, Proactively share knowledge with peers, Education And Experience What you need to bring: First-level university technical degree or equivalent technical qualifications 2-4 years of technical experience in IT with a focus on technical selling Knowledge-based and experienced-based relevant industry certifications are preferred, Knowledge And Skills Intermediate level experience participating in solution configurations and overall architecture design along with assisting in creating demos and proofs-of-concept (POC) to meet customer requirements, Intermediate level understanding of the company portfolio of products, software, and services and how these fit into solution domain specialization, Intermediate level understanding of aaS business models, differentiated value, solutions, and workloads, along with the ability to prioritize aaS offerings and consumption models that will achieve the customers outcomes, Intermediate-level written and verbal communication skills, including emphasizing, collaborating, active listening and storytelling, and ability to communicate in English and applicable local languages (both in-person and virtual) as needed to perform job requirements, Demonstrates intermediate-level discussion and persuasion skills, as well as respectfully questioning and challenging proposed solutions, Intermediate-level business and financial acumen?sales cycle, pipeline growth, reporting, ability to influence, business strategy linkage?with an awareness of functional responsibilities of various customer business roles, Intermediate consultative and value selling skills, including presenting, whiteboarding, objection handling, and closing skills to proactively help customers make business decisions, Intermediate-level company business knowledge, technical tools, and standard customer relationship management (CRM) systems and tools, Hands on experience with one or more products, solutions, tools, or services aligned to respective job responsibility, Ability to deliver live demonstrations or walk throughs of products, solutions, tools or services to customers, partners, and other stakeholders, Intermediate-level project and time management skills or experience with excellent analytical and problem-solving skills, including appropriate due diligence, Intermediate-level knowledge of partner offerings and how/when to leverage them for deals within an area of specialization, Intermediate level knowledge of different types of partners and products, relevant to assigned solution domain and understanding of the company's go-to-market strategy, Additional Skills Accountability, Accountability, Active Learning (Inactive), Active Listening, Assertiveness, Bias, Building Rapport, Buyer Personas, Coaching, Complex Sales, Creativity, Critical Thinking, Cross-Functional Teamwork, Customer Experience Strategy, Customer Interactions, Design Thinking, Empathy, Financial Acumen, Follow-Through, Growth Mindset, Identifying Sales Opportunities, Industry Knowledge, Intellectual Curiosity (Inactive), Long Term Planning, Managing Ambiguity {+ 6 more} What We Can Offer You Health & Wellbeing We strive to provide our team members and their loved ones with a comprehensive suite of benefits that supports their physical, financial and emotional wellbeing, Personal & Professional Development We also invest in your career because the better you are, the better we all are We have specific programs catered to helping you reach any career goals you have ? whether you want to become a knowledge expert in your field or apply your skills to another division, Unconditional Inclusion We are unconditionally inclusive in the way we work and celebrate individual uniqueness We know varied backgrounds are valued and succeed here We have the flexibility to manage our work and personal needs We make bold moves, together, and are a force for good, Let's Stay Connected Follow @HPECareers on Instagram to see the latest on people, culture and tech at HPE, Job Sales Job Level TCP_02 HPE is an Equal Employment Opportunity/ Veterans/Disabled/LGBT employer We do not discriminate on the basis of race, gender, or any other protected category, and all decisions we make are made on the basis of qualifications, merit, and business need Our goal is to be one global team that is representative of our customers, in an inclusive environment where we can continue to innovate and grow together Please click here: Equal Employment Opportunity, Hewlett Packard Enterprise is EEO Protected Veteran/ Individual with Disabilities, HPE will comply with all applicable laws related to employer use of arrest and conviction records, including laws requiring employers to consider for employment qualified applicants with criminal histories, Show more Show less

Role & responsibilities Experience in operation and trouble shooting of process in plant. Isolation and purification of different organic compound using column chromatographic and crystallization techniques. Optimize the process parameters, what-if studies, holding studies etc. for scale up. Investigation of OOS/OOT and stability related issues. Handled various reagents like NaH, NaBH4, Br2, BHA, n-BuLi,TMSCl, TFA,PPA, Raney Nickel, Pd/carbon & also hazardous chemicals like POCl3, SOCl2 etc. Reactions performed like Hydrogenation,Brominaion,Oxidation,Reduction and condensation. Handling of Moisture sensitive reactions. Study and understand the project requirements, identifying and collection of suitable literature. Support lab manager to prepare weekly technical reports and other project related technical documents (impurity profile tables,Plant batch data,developmental reports) Executing assigned reactions of project. • Looking after the Safety equipments management and maintaining it as per regulatory requirement in R&D lab. • Study the MSDS of each chemical using in every new project and make arrangement of Safety equipments accordingly. Handled HPLC system of Agilent technologies Ezichrome (A.04.07) and version Open Lab cds2.4 • Good in Thin layer chromatography & Column chromatography. Preferred candidate profile Perks and benefits

Roles and Responsibilities Develop new APIs through organic synthesis, method development, and optimization. Conduct literature reviews to stay updated on latest research trends and technologies. Ensure compliance with GMP guidelines during API manufacturing processes. Collaborate with cross-functional teams for product development, scale-up, and commercialization. Perform impurity analysis using techniques like NMR, DSC, etc. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Ph.D/Doctorate in Chemical Sciences from a recognized university. Strong expertise in areas such as API synthesis, organic chemistry, method development/validation/transfer/methodology. 9-14 years of experience in Research & Development (R&D) or related field. Key Responsibilities Literature Review & Route Identification Perform comprehensive literature and patent searches (SciFinder, Reaxys, PubChem, etc.). Identify and evaluate synthetic routes for APIs, intermediates, and impurities. Synthetic Research & Development Plan and perform multi-step organic synthesis experiments. Develop and optimize cost-effective and robust synthetic processes. Work on impurity profiling and synthesis of known/unknown impurities (including nitrosamines/nitroamines). Process Optimization & Scale-Up Support Optimize reaction parameters for higher yield, purity, and reproducibility. Support process development, kilo-lab trials, and technology transfer. Address scale-up challenges in collaboration with process R&D teams. Analytical Collaboration Interpret analytical data (HPLC, LC-MS, NMR, IR) for structure confirmation. Work with Analytical R&D to characterize intermediates, APIs, and impurities. Documentation & Compliance Maintain accurate lab notebooks, experiment records, and reports. Prepare technical documents for DMFs, ANDAs, and regulatory submissions. Ensure GLP, GMP, EHS, and data integrity compliance. Teamwork & Leadership (For Sr. Executive Level) Independently lead assigned projects with minimal supervision. Mentor and guide junior chemists/trainees in lab activities. Provide technical support for regulatory/customer queries.

Position Purpose : This position is responsible for daily overall functioning of the R & D laboratory, provide guidance perform experiments and prepare documentation for R & D and Pilot Plant. Role & Responsibilities: To Plan & perform Lab experiments for Process development as per Guideline To modify & optimise lab process for plant scale-up batches To keep record of all experiment taken To prepare & record the documents of R&D & Pilot plant batch work on day to day To execute and assist demo batches to plant chemist To Deliver the project/Product as per committed timeline To provide online support to production dept. for trouble shooting To look after glass wares, lab wares / instruments, calibration & maintenance. To Prepare the process write up with document team. To submit tech transfer document to QA along with PDR To follow the guideline and SOPs of R&D department To create healthy working atmosphere in R&D To train & guide trainee chemist Be always careful about chemical handling by following safety measures and also give training to juniors. To coordinate with ADL, Plant and maintenance. To take work as per allocation for officers and operators. To carry out literature search for better alternate safe process.

Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of how best teams integrate and work together to achieve company goals. Impact Responsible for the accuracy of own work. Receives close supervision and duties are clearly defined. Methods and tasks are described in detail. Leadership Has no supervisory responsibilities. Problem Solving Uses existing procedures to solve standard problems. Has limited opportunity to exercise discretion. Interpersonal Skills Exchanges information and ideas effectively. Responsibility Statements Maintains employee records through data entry. Performs calculations for outstanding payments due on termination or leave of absence. Coordinates termination details to ensure assets are returned/access is revoked on the employee 2019s last day. Compiles data for review and reporting. May perform routine analysis for internal review. Performs other duties as assigned. Complies with all policies and standards.

Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of how best teams integrate and work together to achieve company goals. Impact Responsible for the accuracy of own work. Receives close supervision and duties are clearly defined. Methods and tasks are described in detail. Leadership Has no supervisory responsibilities. Problem Solving Uses existing procedures to solve standard problems. Has limited opportunity to exercise discretion. Interpersonal Skills Exchanges information and ideas effectively. Responsibility Statements Maintains employee records through data entry. Performs calculations for outstanding payments due on termination or leave of absence. Coordinates termination details to ensure assets are returned/access is revoked on the employee\u2019s last day. Compiles data for review and reporting. May perform routine analysis for internal review. Performs other duties as assigned. Complies with all policies and standards.

Roles and Responsibilities Conduct analytical testing of finished products, including dissolution, UV-Vis, KF, FTIR, and GLP compliance. Develop and validate analytical methods for solid oral OSD products using techniques such as GC, HPLC, and UV spectroscopy. Perform method transfer and validation activities to ensure accuracy and reliability of test results. Collaborate with cross-functional teams to resolve OOS/OOT issues and implement corrective actions. Maintain accurate records of laboratory data, reports, and documentation in accordance with cGMP guidelines.

You will be joining our team as a Deputy Manager/Manager, Analytical method transfer, responsible for delivering developed analytical assays from R&D scale to GMP-compliant commercial quality control labs. Your role will involve overseeing projects related to analytical method transfer, collaborating with cross-functional teams, and ensuring technology transfer and assays qualification activities are conducted in compliance with GLP and GMP standards. The ideal candidate will possess expertise in cGMP, regulatory requirements, technical troubleshooting, method transfer, method validation, technology transfer, and laboratory techniques to support routine testing and release of research and cGMP grade materials. You will be directly involved in drafting technology transfer documents, risk assessments, process FMEA, method validation protocols, facility fit assessments, and other related activities necessary for the release and testing of microbial and mammalian fermentation-based products. You should have familiarity with analytical assays such as HPLC, GC, SDS-PAGE, agarose gel electrophoresis, densitometry, dd-PCR, RT-PCR, ELISA, UV-Visible spectrophotometry, western-Blot, as well as microbiological techniques like BET, BioBioburdend Sterility testing. Additionally, the position may entail assisting in cell bank testing and release under cGMP regulations and coordinating with third-party collaborators for external testing as needed. Your responsibilities will also include authoring and reviewing research studies, compiling experimental data, and contributing to protocols, study reports, and publications with minimal supervision. You will work as part of the method transfer and method validation team, ensuring timely and successful completion of process transfers while addressing any unexpected technical challenges. We are looking for individuals who are enthusiastic, highly motivated, and capable of multitasking. The role requires working collaboratively within a team environment and independently across various aspects of projects related to microbial-derived products.,

Division Department Sub Department 1 Job Purpose Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements Key Accountabilities (1/6) Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission Conduct extensive literature search Analyse raw materials, intermediates, final API, forced degradation samples, stability samples, GTIs on different analytical instruments under GLP environment Conduct Fate and Purge studies/carryover studies Perform method validation Prepare specification based on carryover studies Perform method transfer to manufacturing units for routine QC analysis Key Accountabilities (2/6) Investigate plant queries like OOS, OOT for quality control of drug substance and products in order to provide corrective actions and check samples for impurities Review the entire process to identify the source of impurities Perform degradation study to identify impurities Analyse packing material in case of leachable and extractable Key Accountabilities (3/6) Characterise final API and impurities to prepare the test or working standards for routine laboratory purpose Perform chemical and physicochemical analysis to arrive at the purity, potency and structural identity of the molecule Store impurities as per chemical properties Key Accountabilities (4/6) Conduct the incubation and perform complete analysis of stability samples to conclude the storage, shelf life and packing conditions of the final API Incubate samples at various conditions Select packing material Perform analysis of stability samples Compile trend and identify degrading impurity Evaluate shelf life of the drug substance for expiry conclusion Key Accountabilities (5/6) Keep track of the latest innovation and applications which can be used with the existing techniques to investigate / resolve critical issues Attend various webinars, conferences Evaluate various demo datas generated by instrument manufacturers at their demo labs Compare various parameters like shorter run time, solvent consumption, cost factor and environment safety Key Accountabilities (6/6) Major Challenges Changes in the Regulatory guidelines: Keeping abreast with latest regulatory guidelines and interaction with RA department Conflict regarding the priorities of samples: Interaction with cross-functional team along with the managers to prioritise the samples Delay in cross-functional activities: Interaction with immediate supervisor for clarity of responsibility Difference in instrument compatibility for analysis: Escalated to supervisors Key Interactions (1/2) API R&D/ F R & D for planning, product information and result discussion (daily) RA for regulatory discussion for Deficiency, DMF filing (as per need basis) IP or patenting any product or getting information of any known patent (as per need basis) Units for sample requirement, Method transfer, Method validations, investigations (weekly) Purchase & Imports for impurities/chemicals, instrument and Equipment (as per need basis) HR for Personal discussion and organisation rules and regulation, company policy discussion (as per need basis) Key Interactions (2/2) Outsource Labsfor external analysis (weekly) Vendors-Instruments/Equipment for service and support (as per need basis) Application specialists for application support to resolve any challenging queries (as per need basis) Dimensions (1/2) Minimal error for lab compliance and maximise output Maximise instrument utility by working in shifts Online delivery of analytical data to R&D Ensuring 100% compliance with the regulatory Meet the turnaround times for projects Publish two papers in a year Dimensions (2/2) Number of trials on various techniques during development stages Key Decisions (1/2) Result discussion for online monitoring of samples with R&D Change in method of analysis with supporting analytical data to the respective Group Leader Key Decisions (2/2) Education Qualification Sc Relevant Work Experience Minimum 15 years of experience in pharmaceutical industry with analytical experience Good presentation and communication skills are preferable Show

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Hiring - ADL (AMD) - Nagpur Location Location - Nagpur MH Company - Pharma (MNC) Core OSD Formulation + Method Validation Experience Msc or Mpharm /bpharma Responsibility - Sr. Role Description 1. Analytical Method Development New analytical method development and troubleshooting of existing method of different types of Oral solids dosage form (Granules, Tablets, Pellets, Capsules etc.) for Regulated market projects or as per business need. 1. Ensure robust & cost effective method development of product by considering the available facility & resources 2. Conduct Literature survey, different pharmacopoeia & pharmacopeia forum search and review & application of same in AMD. 3. Conduct Pre-formulation studies (API characterization and Drug-Excipients compatibility studies). 4. Operation and calibration of different analytical instruments. 5. Take into account existing QC facility while developing any product for successful method transfer. 6. Analytical method validation and method transfer activity. 7. Maintain the Good Laboratory practices, Good Documentation practice and Good hygiene practices. 8. Prepare for all type of internal and external audit/inspection. 2. Stability Studies of R&D Products 1. Responsible for stability studies of new R & D products for Regulated market projects. 2. Responsible for interpretation of stability data of the products related to analytical methods. 3. Observations of stability trend and discussion of same with formulation team. 4. Management of stability batches analysis and take the decision for stability studies of different batches as per requirement. 3. Routine Support to F&D Team 1. Responsible for providing routine support for the new product development for regulated market projects. 2. Planning and execution of routine batches analysis in minimum possible time. 3. Analytical data review and to provide the online results and observations to F&D Team. 4. GLP, GDP and Documentation Support 1. Responsible for maintaining the overall GLP and GDP in the Laboratory and providing overall GLP support during day to day activities. 2. Maintenance of working standards, Impurities and reference standards 3. Responsible for preparation, review and approvals of all the documents generating in the ARDL laboratory. 5. Team Building 1. Ensure continuous training and up-gradation of knowledge of the R&D team so that they are at the cutting edge of technology. 2. Set challenging goals for team members to ensure they deliver as per their true potential & as per the need of organization. 3. Identify & nurture the top talent of team. 4. Arrange a monthly interaction with team members to understand & resolve their performance bottle necks & also give them feedback for course correction. Performing any other responsibility as per the requirement, in the larger interest of organization. Interested!!!Please share your cv at Neetij@selectsourceintl.com Thanks & Regards

Job Title: Scientist / Sr. Scientist API R&D Department: Research & Development Location: Kolkata Key Responsibilities: Analytical Method Development: Develop and validate robust analytical methods (HPLC, GC, LC-MS, UV, FTIR, etc.) for quantification, purity, stability, and impurity profiling of APIs (maintaining GLP) Method Validation and Verification: Conducting studies to confirm that the developed methods are suitable for their intended purpose, meeting parameters like specificity, accuracy, precision, linearity, and ruggedness, Prepare and review technical documentation, including method development reports, validation protocols/reports, and regulatory submission documents. Method Transfer: Facilitating the successful transfer of analytical methods to quality control or production laboratories, ensuring reproducibility across different instruments and environments. Stability Studies: Implementing and managing API stability programs to monitor how products perform under various environmental conditions over time, ensuring continued compliance with quality standards. Regulatory and Quality Support: Providing analytical data and reports in support of regulatory filings and ongoing quality assurance requirements. Troubleshooting and Problem Solving: Using analytical expertise and state-of-the-art equipment to resolve issues, such as product failures or abnormal impurity profiles, quickly and accurately. Instrument Calibration and Maintenance: Ensuring analytical instruments are properly maintained and calibrated for reliable and reproducible results. Reference Standard Management: Handling selection, qualification, and maintenance of reference standards for ongoing quality control. Routine analysis work Qualifications & Skills: M.Sc. / M.Pharm / B.Tech/M.Tech in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline. 3–8 years of relevant experience in a pharmaceutical R&D or CRO environment. Hands-on expertise in analytical instruments (HPLC, GC, UV-Vis/IR etc.). Sound understanding of ICH, USP/EP, and regulatory requirements. Proficient in data analysis, interpretation, and documentation. Strong problem-solving and communication skills; ability to work in cross-functional teams.

SENIOR QUALITY CONTROL ANALYST Job Objective: The Quality Control (QC) Analyst specializing in Method Validation and Method Development is responsible for developing, validating, and transferring analytical methods for pharmaceutical raw materials, intermediates, and finished products. The role ensures compliance with regulatory requirements and contributes to continuous improvements in analytical methodologies. Qualifications: Bachelors/Masters degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or related field. Experience: More than 8 years of experience in method validation, method transfer, and regulatory compliance within a pharmaceutical QC or analytical development environment. Job Responsibilities: Method Development & Optimization: Develop and optimize analytical methods for assay, dissolution, related substances, and residual solvents using techniques like HPLC, GC, UV-Vis, FTIR. Establish and refine chromatographic conditions, mobile phases, and detection parameters for improved sensitivity and reproducibility. Conduct forced degradation and stability-indicating method development as per ICH Q1A guidelines. Method Validation & Transfer: Perform method validation as per ICH guidelines covering accuracy, precision, specificity, linearity, robustness, and system suitability. Prepare and review method validation protocols and reports. Execute method transfer activities between R&D, QC, and manufacturing sites following GMP requirements. Regulatory Compliance & Documentation: Ensure analytical methods meet US FDA, EU GMP, MHRA, WHO, and other regulatory expectations. Maintain accurate documentation as per Good Documentation Practices (GDP). Support regulatory filings by preparing analytical method validation reports and technical dossiers. Assist in responding to regulatory queries and audits related to analytical methods. Instrumentation & Troubleshooting: Operate and maintain analytical instruments such as HPLC, GC, UV-Vis, FTIR, and dissolution testers. Troubleshoot chromatographic issues related to retention time shifts, peak tailing, and resolution problems. Participate in instrument qualification (IQ/OQ/PQ) as needed. Collaboration & Process Improvement: Work closely with R&D, Manufacturing, and Quality Assurance teams for seamless method transfer. Investigate out-of-specification (OOS) and out-of-trend (OOT) results to identify root causes. Contribute to continuous improvements in analytical techniques and laboratory efficiency. Technical Skills: Strong expertise in HPLC, GC, UV-Vis, FTIR

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

Planning and executing assay-runs for cell based assays and ELISA as part of Method Development and Method Qualification studies Analysis of the data using parallel line analysis and equivalence testing Writing protocols and reports for Method development and Method qualification studies Maintenance of the cell lines, preparation of cell banks Review of raw data and data recording sheets and to ensure good documentation practices. Planning of day-to-day activities independently. Trouble shooting of the issues (if any) aroused during execution of assay-run. Involving in documents preparation for SOP, STP, MOA.