144 Method Validation Jobs - Page 3

Opportunity with SGS India for the position of Chemist (Wet Chemistry) | Location - Ahmedabad Note: This position would be on 3rd Party Payroll. Company Profile: Established in 1878, SGS transformed grain trading in Europe by offering innovative agricultural inspection services. SGS is the world's leading inspection, verification, testing and certification MNC. We are recognized as the global benchmark for quality and integrity. With more than 96,000 employees, we operate a network of more than 2,700 offices and laboratories around the world. We cater quality services to 9 Businesses in India like Consumer & Retail Services, Oil & Gas, Industrial services, AFL, Minerals etc. Kindly visit our Global Website: www.sgs.com India Website: www.sgsgroup.in Experience - Fresher to 1-2 Years Education - M. Sc in Chemistry Walkin Details - 12th June and 13th June Time - 9:30 am - 4:30 pm Location - Ahmedabad, Gujarat Following is the Job Description for Chemist (Wet Chemistry): To perform sample preparation by using appropriate method. Assist Section In-charge for new method development and method validation to upgrade lab capability. Handling of CRM and stability check of CRM. Development, modification, verification and validation of methods Result entry in SLIM. Internal verification of equipment and equipment maintenance. Responsible for method validation To assist QAC and Section In-charges to maintain calibration status and their records. Verify Instrument maintenance and Calibration of Chemical and instrument lab area. Ensure compliance with mandatory local and other laws pertaining to health safety environment protection, within the lab and outside surroundings, compliance to SGS OI procedures Interested Candidates please share your updated CVs on fleur.dsouza@sgs.com

Opportunity with SGS India for the position of Chemist | Location - Ahmedabad Note: This position would be on 3rd Party Payroll. Company Profile: Established in 1878, SGS transformed grain trading in Europe by offering innovative agricultural inspection services. SGS is the world's leading inspection, verification, testing and certification MNC. We are recognized as the global benchmark for quality and integrity. With more than 96,000 employees, we operate a network of more than 2,700 offices and laboratories around the world. We cater quality services to 9 Businesses in India like Consumer & Retail Services, Oil & Gas, Industrial services, AFL, Minerals etc. Kindly visit our Global Website: www.sgs.com India Website: www.sgsgroup.in Experience - Fresher to 1-2 Years Education - M. Sc in Chemistry Walkin Details - 12th June and 13th June Time - 9:30 am - 4:30 pm Location - Ahmedabad, Gujarat Following is the Job Description for Chemist: To plan, understand and complete the allocated work within the stipulated time with accuracy and precision strictly as per relevant SOPs in coordination with respective Section In-charge. Ensure the performance of equipment / instrument before going to use it. If she feels any SOP needs to be changed, this is her duty to bring this in to the notice of Section In-charge. In absence of Section In-charge, entertain the queries and interact with internal audits. To Assist Technical Manager to entertain all the technical queries made by external as well as internal clients. Analysis of Agri & Food products and documentation. Verify Instrument maintenance and Calibration of Chemical and instrument lab area. Assist SI for new method development and method validation to upgrade lab capability. Handling of CRM and stability check of CRM. Result entry in SLIM. Development, modification, verification and validation of methods Internal verification of equipment and equipment maintenance Responsible for method validation Responsible for intermediate checks of standards Responsible for critical consumable checks Interested Candidates please share your updated CVs on fleur.dsouza@sgs.com

We are seeking a Fresher Quality Control Analyst to join our quality control team.This is an excellent opportunity for someone looking to start their career in quality control within the pharmaceutical or manufacturing industry. Annual bonus

KWALITY PHARMACEUTICALS LTD. 6TH, MILE STONE, VILL. NAG KALAN, MAJITHA ROAD, AMRITSAR- 143601.(INDIA) About Our Organisation : Kwality Pharmaceuticals Ltd. is a manufacturer of finished pharmaceutical formulations in a dosage form. The company was incorporated on May 4 1983, and is ever progressing in Domestic and International markets. Kwality Pharma was Incorporated on May 4th 1983 by Mr. Ramesh Arora ( Founder ) of the company . Our company is based on its commitment to high quality and timely supplies. Kwality Pharmaceuticals Ltd are leading manufacturer & exporters of pharmaceutical formulations in Liquid Orals, Powder for Oral Suspension, Tablets, Capsules, Sterile Powder for Injections, small volume injectables, Ointments, External Preparations, ORS and many more.... in various categories like Beta Lactam & non-Beta Lactam, Hormones, Cytotoxic (Oncology) and Effervescent as per new GMP norms. The company specializes in handling customized business as per the requirements. The company has registered its products in different countries of Europe, Africa, Asia, Central American, and South American Countries & CIS Countries. What we are looking for : QMS / Process validation / Method Validation Role & Responsibilities : • To review, maintain and implement change control management. • Tracking and trending of CAPA for site and its verification of CAPA effectiveness. • Handling of regulatory inspections and preparation of audit compliance reports. • To review and approval of sampling protocols, validation protocols and reports. • Responsible for review and tracking of technical agreements for the site. • To involve in Preparation, Approval, Issuance and Retrieval of Documents. • Responsible for assessment, review and tracking of vendor service agreements. • To ensure preparation and approval of Annual Product Quality Reviews. • Review of incident investigation reports and monitoring of CAPA arising from the incidents. • To Review and preparation of specification / STP • To ensure adequate and timely review, approval of incident investigations and verification of the action plans. • Review and approval of Site master file, Quality Manual and Validation Master Plan. • To ensure reserve samples of finished products are maintained as per defined SOP. • Ensure cGMP compliance at site. • Responsible for ensuring quality and compliance wherever the GMP activities performed within the department and at the site.

Roles and Responsibilities Develop analytical methods for different dosages form using techniques such as HPLC, GC, UV-Vis Spectrometer, Ion Chromatography, etc. Validate developed methods according to cGMP guidelines and company SOPs. Conduct method transfer activities to ensure successful implementation of new methods at different sites. Collaborate with cross-functional teams to resolve method-related issues and improve overall process efficiency. Maintain accurate records of all experiments, results, and reports in accordance with regulatory requirements. Desired Candidate Profile MS/M.Sc (Science) degree in Chemistry or related field from a recognized university. 2-7 years of experience in Analytical Research & Development (AR&D) industry. Strong knowledge of Analytical Method Development, Method Validation, and Analytical Development principles.

Responsible for developing the cell based assays and conduct routine screening. Expert knowledge/skill sets in cell culture, biochemical and cell based assays, animal tissue samples. Analytical techniques : Cell culture, ELISA, flow-cytometry, Confocal microscopy, animal Industry - Pharma / Biotech / Clinical Research Functional Area - RD, Pharmaceuticals, Biotechnology Role Category - Research Scientist Desired Profile PG - M.Sc - Bio-Chemistry, Microbiology, M.Tech - Bio-Chemistry / Bio- Technology.

Role & responsibilities 01 Quality Control Functions: 1.1 To ensure that the laboratory carrying out its testing, calibration, validation and all other technical activities in such a way to meet GLP requirements. 1.2 To carry out all technical activities and implementation of documented quality system. 1.3 To plan, schedule and monitor analysis of Raw Materials, Premix, Packing Materials, In-process materials, Finished products, Microbiological analysis, Water analysis and ensure that they meet defined relevant quality standards. 1.4 Periodically review logbooks, reports and test protocols related to Raw Materials, Premix, Packing Materials, Microbiological analysis, In-process and Finished products for proper entries, accuracy and completeness and ensure that they meet defined relevant quality standards. 1.5 To handle Quality management events according to SOP and complete its documentation with corrective and preventive actions. 1.6 To ensure that updated Specifications, Standard Testing Procedure, Test protocol and documents are available for use. 1.7 To review the resources of Manpower, Instruments, Equipment, Material and advise Management on the provision with justification. 1.8 To train the personnel in the department regarding Chemical Testing, Instrument qualification & current regulatory guidelines. 1.9 To establish effective communication systems with other departments including Commercial departments to achieve effective and efficient service from Quality Control Department. 1.10 To ensure implementation of cGMP in laboratory. 1.11 To ensure Qualification, Annual Maintenance and Calibration of QC instruments. 1.12 To ensure Management of Standards, Chemicals, Reagents and Glasswares. 1.13 To Review and approval of new or revised SOPs. 1.14 To handle instrument troubleshooting and interact with service Engineer in case of instrument breakdown. 1.15 To ensure compliance of Laboratory safety practices and firefighting devices. 2.0 General function 2.1 To provide compliance of Audit observations. 2.2 To take adequate measures to ensure updating of information and knowledge of the key people in the Quality control. 2.3 To provide support to planning, production, finish product for timely release of the goods for dispatch. 2.4 To monitor the microbiological analysis and ensure that all testing is carried out. 2.5 To create SOP awareness by continuous training. 2.6 To ensure good housekeeping of laboratory and up-keep of laboratory. 2.7 Self-updation of current regulatory guidelines. 2.8 Self inspection of other departments, as and when scheduled. . 2.9 Take necessary measures to prevent accident/incident and help in accident/incident Investigation. 3.0 Adherence and compliance to cGMP requirements. 3.1 Undertaking any other work, either for this department or any other department which the organization, which may be requested by the Plant Manager, for which training and/or an explanation has been provided and understood.

The selected candidate will work directly in a private setup focused on stock and commodity trding in a residential setup with free accommodation. This role is ideal for someone who is looking for a long-term, stable opportunity. Free meal Cafeteria Food allowance Shift allowance Over time allowance House rent allowance Flexi working Accessible workspace Assistive technologies Sports for women

Candidate must have experience from chemical manufactiring industry.

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As a part of our Cost & Productivity Reinvention (C&PR) practice, you will help organizations reimagine and transform their supply chains for tomorrow"”with a positive impact on the business, society and the planet. Together, let's innovate, build competitive advantage, improve business, and societal outcomes, in an ever-changing, ever-challenging world. Help us make supply chains work better, faster, and be more resilient, with the following initiatives: Be a part of the Accenture Cost & Productivity Reinvention (C&PR) practice that has expertise in delivering projects with quantified savings in the indirect and direct categories. Support and lead Cost & Productivity Reinvention (C&PR) engagements, including sourcing for direct, indirect categories, conducting spend analyses, market intelligence, identifying cost reduction or process improvement opportunities, data analytics, so on. Take the lead on all digital sourcing and technology initiatives. Work towards Accentures Cost & Productivity Reinvention (C&PR) approach for EBITDA improvement including direct material cost transformation, indirect material cost transformation, logistics cost transformation, manufacturing efficiency improvement & cost transformation conduct data analytics across financial data and operational data. Deliver cost transformation engagements for clients across industries. Bring your best skills forward to excel in the role: Strong analytics skills driven by the next wave digital and technology initiatives Ability to solve complex business problems and deliver client delight Excellent communication, interpersonal and presentation skills Cross-cultural competence with an ability to thrive in a dynamic environment Read more about us. Recent Blogs Qualifications Your experience counts! MBA from Tier-1 B School 1-4 years of experience for an Analyst and 4-8 years of experience for a Consultant, across direct materials, manufacturing, logistics, market intelligence, EBITDA improvement programs , Business case development, Strategy formulation, Spend analysis across financial and operational data Experience in a consulting firm and global exposure is desirable. Retail, Healthcare, CG&S, Automotive, Industrial, Logistics industry experience would be preferred. Hands-on experience with analytical tools such as MS Excel, PowerBI, Alteryx would be an added advantage What’s in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. 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Our Global Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world.For more information visit https://www.accenture.com/us-en/Careers/global-network At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team

Provide remote analytical support to PPL sites, including review of analytical data and preparation of documents such as specifications, test methods, and protocols. Upload documents for review in ENSURE and initiate QMS elements in TrackWise/eDMS. Prepare and review stability protocols and reports, and perform stability data trending and analysis B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Review of analytical data generated in the analytical lab (QC/AS) including but not limited to Cleaning verification data, IPC , raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data according to cGMP, GDP, in a timely manner. Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc Knowledge in analytical data review in Empower/ Chromeleon / Open-Lab / Lab-Notebooks / LIMS / QMS module. Analytical Method Development and Documentation: Create and revise working test methods in compliance with compendia requirements and laboratory practices to support analytical testing. Change Request Forms (CRF) Management: Routinely initiate and manage Change Request Forms via the TrackWise system, including updates to product specifications and Certificates of Analysis (COA). Data Trending and Out-of-Trend (OOT) Analysis: Perform trend analysis of release testing data to identify OOT results. Develop, implement, and maintain procedures for trending and statistical data evaluation. External Data Review: Review analytical data generated by external laboratories to ensure compliance with specifications and quality standards. Share the review deficiencies with site team for further actions. Develop, revise, and review stability protocols and documentation in accordance with ICH guidelines and product-specific requirements, prepare stability summary reports with statistical analysis and trending to evaluate data and ensure regulatory compliance and data integrity . Conduct thorough Compendia reviews of USP (United States Pharmacopeia) monographs and ensure alignment with internal specifications and regulatory expectations. To participate and support site during customer audits and regulatory inspection. Lead and participate any other task assigned by HOD .

To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products. Essential Functions: Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc). Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP). Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage. Performing qualification, periodic calibration, and maintenance of laboratory instruments. Maintain proper cleanliness, calibration, and qualification status of analytical instruments. Coordinate with warehouse and QA for sampling of incoming materials as per SOPs. Ensure proper labeling, storage, and disposal of samples and reference standards. Support internal, customer, and regulatory audits by providing required documentation and clarifications. Implement corrective and preventive actions (CAPA) as per audit observations. Additional Responsibilities: Participate in method validation, verification, and transfer activities as required. Assist in updating and reviewing SOPs, specifications, and analytical procedures. Contribute to continuous improvement initiatives in the QC department. Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor. Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.

Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.

Role & responsibilities : Routine analysis & Stability Analysis (assay, RS, dissolution, water content etc.) of R&D formulation projects (solid & liquid orals, injectables) Daily calibration of pH meters, balances etc. Stability sample management (loading & withdrawal as per stability plan) Preparation of Stability Reports & other protocol based study reports for assigned projects, as applicable Hands-on experience of analytical instrumental techniques (HPLC with chromatographic software etc.) Assisting analytical method development/validation/method transfer activities, as per need Supporting other assigned lab responsibilities for GLP compliance Preferred candidate profile

Analysis of in-process, raw materials, intermediates API with expertise on HPLC and wet chemistry. To carry out analytical method development and method validation, in-process samples and finished products. To carry out analytical method transfer activity to QC. Trouble shooting of analytical instruments for difficulties faced during day-to-day operations. Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc. Literature Search for development of analytical methods. To ensure that all activities undertaken are executed in the framework of good laboratory and documentation practices and the existing quality systems are adhered To ensure safe practices are followed during the execution of activities and strict adherence to the EHS systems of the site Hands on experience on Instruments viz., Auto-titrator, HPLC and UV etc. Knowledge of regulatory requirements for different markets (US, EU, Canada etc.) Knowledge on ICH guidelines, forced degradation studies, impurity profile, etc. Your experience and qualifications M.Sc. / M. Pharm./ Ph.D. 4-8 Years relevant experience Sound knowledge of Chemistry and analytical method development, method validation and transfer, Instrumental method of analysis and logical approach for complex generic API. Teva s Equal Employment Opportunity Commitment

Perform Polymorph screening as per guideline Follow cGMP Documentation and EHS compliance at workplace Perform Virtual and Experimental Screen and evaluate all literature that relates to solid-state issues Screen new forms by performing stress tests and File ASAP new forms in patent application Analyze laboratory samples by XRD, DSC, TGA and other characterization techniques Assess kinetic stability and interconversions and produce scheme of all polymorphic transitions Produce solubility curves of different polymorphs and assess thermodynamic stability relationships Develop detection methods to assess polymorphic purity and monitor in the laboratory samples Support the development of the crystallization process with full characterization Monitoring stability and physical properties of micronized/milled materials Perform calibration, method development, method validation, and troubleshooting using various instruments like PXRD, DSC, TGA and Particle size analyzer Knowledge of various regulatory guidelines w.r.t. method development, product development, and documentation Your experience and qualifications M.Sc. Chemistry/B Tech (Chemical Engineer) with 1-5 years of experience in relevant industry and profil

We have opening for Formulation AR&D Department. Job Openings: 6 Nos Position : Research Analyst or Sr Research Analyst Handling Instruments like HPLC 1-5 Years Exp 2- 8 Yrs. Job Location: Pashamylaram - Patancheruv (Telangana) Salary : As Per Company Norms Qualification: Pharm or M.Sc. or M .Pharm Job Description 1) Method Development and routine analysis of Assay, Dissolution, Related substances, Content Uniformity, Blend Uniformity. 2) Responsible for Analytical Method Validation activities for solid orals and injectables. 3) Responsible for Routine and Stability analysis activities for solid orals and injectables. 4)Responsible for the Review of documents generated in Method development activity. 5)Responsible for the Preparation and Review of Tentative method of analysis and Method development Reports. Ref to Friends or colleagues. Please share me update resume: careers@biophore.com Total Exp : Current CTC: Exp CTC: Notice Period: Current Designation:

Over see the development, implementation, and validation of analytical methods used for the testing of Active Pharmaceutical Ingredients (APIs) in compliance with internal standards, industry regulations, and customer requirements. The role requires leadership skills to manage a team, ensure compliance with good laboratory practices (GLP), and drive continuous improvement in method validation processes. This position also involves close collaboration with various cross-functional teams including R&D, Regulatory Affairs, and Quality Assurance.

Roles and Responsibilities Conduct quality control analysis of bulk drugs, APIs, and pharmaceutical products using techniques such as HPLC, GC, and method validation. Perform stability studies to ensure compliance with GMP guidelines. Calibrate instruments accurately and maintain records of instrument maintenance schedules. Ensure accurate documentation of test results, reports, and certificates of analysis. Collaborate with cross-functional teams to resolve quality issues. Only male candidates

Greeting from Biophore India pharmaceutical Pvt Ltd. Hiring for Formulation Analytical R&D Department. Job Openings: 6 Nos Position : Research Analyst or Sr. Research Analyst Exp 2 - 7 Yrs. Job Location: Pashamylaram - Patancheruv -Hyderabad. Salary : As Per Company Norms Qualification: M .Pharma or M Sc or B.Pharm Job Description 1) Method Development and routine analysis of Assay, Dissolution, Related substances, Content Uniformity, Blend Uniformity. 2) Responsible for Analytical Method Validation activities for solid orals and injectables. 3) Responsible for Routine and Stability analysis activities for solid orals and injectables. 4)Responsible for the Review of documents generated in Method development activity. 5)Responsible for the Preparation and Review of Tentative method of analysis and Method development Reports. Please Carry below documents: 1. Updated resume. 2. Last 3 months pay slips or bank statement 3. Offer letter or Increment letter from the present employer,4. Photocopies of all Education certificates Ref to Friends or colleagues.

Greeting from Biophore India pharmaceutical Pvt Ltd. Hiring for Formulation Analytical R&D Department. Position : Research Analyst or Sr. Research Analyst Exp 2 - 7 Yrs. Job Location: Pashamylaram - Patancheruv -Hyderabad. Salary : As Per Company Norms Qualification: M .Pharma or M Sc or B.Pharm Job Description 1) Method Development and routine analysis of Assay, Dissolution, Related substances, Content Uniformity, Blend Uniformity. 2) Responsible for Analytical Method Validation activities for solid orals and injectables. 3) Responsible for Routine and Stability analysis activities for solid orals and injectables. 4)Responsible for the Review of documents generated in Method development activity. 5)Responsible for the Preparation and Review of Tentative method of analysis and Method development Reports. Ref to Friends or colleagues.

Method development and validation of Genotoxic impurities/ nitroso amine impurities/NDSRIs in pharmaceutical products/ substances by LC-MS/MS. Development of MS compatible methods for the HPLC RS methods for the identification of unknown peaks by LC-MS Development of MS compatible methods for the identification of degradation impurities and unknown impurities

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Role & responsibilities 1. generate sample run list from the laboratory's information management system (LIMS). 2. Set up the LCMS system for sample analysis and run samples according to defined methods. Documents activity according to company sops. 3. Process and review instrument data and document all observations according to company sops. 4. Update data into Laboratory's LIMS. 5. Prepare reagents required for routine analysis. 6. Write or contribute to the review of written SOPs in the laboratory. 7. Understand and comply with all safety procedures applicable to the type of work performed. 8. Work with all laboratory personnel to maintain a safe and clean working environment. 9. Work with the QAU and Safety Officer to address and correct issues arising from quality assurance or safety audits. Preferred candidate profile M.SC/M PHARMA ANY GRADUATE/POST GRADUATE

Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring