Apply for Scientist in Compendial Development Laboratory at USP @Apply Now

Post : Scientist II, Compendial Development Laboratory

Job Description
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
This is a non-supervisory position in in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing USP/NF/FCC method development and method validation projects and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business and the incumbent is expected to support monograph modernization initiatives.

Roles and Responsibilities
• Literature search for the USP/NF/FCC projects.
• To ensure the projects requirements by coordinating with the Group Leader.
• To involve in project execution, method development and validation of USP/ NF/FCC projects.
• To ensure the knowledge on different drug products handling and samples preparations.
• Provided effective technical and scientific expertise regarding drug substance and drug product analytical development
• Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
• Ensure the project updates are provided to the supervisor on regularly.
• To coordinate with Group Leader to complete the USP/ NF/FCC projects within timelines.
• Responsible for preparation and review of SOPs, protocols, reports etc.
• Responsible for review of the records and documents.
• To ensure that the calibrations of the equipment are performed as per the schedule.
• Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.
• To indent the required glass ware, chemicals and columns for the USP/NF/FCC projects.
• To maintain GLP & safety procedures while working in Lab.

Candidate Profile
• Master’s Degree in Chemistry with 3-5 years of experience.
• Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices.
• Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.
• Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
• Good analytical skills in handling method development and Validations for Food ingredients and food products.
• Should have exposure to GMP/GLP environment and documentation procedures. Awareness of ISO/IEC 17025 is desirable.
• Master’s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 3-5 years of experience.
• Excellent technical writing and oral communication skills required.
• Must be able to communicate effectively with diplomacy and enthusiasm.
• Technical and analytical skills required including the ability to interpret technical information.
• Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible.
• Should have fair understanding of GLP regulations and exposed to external regulatory audits

Additional Information
Experience : 3-5 years
Qualification : M.Sc/M.Tech./M.Pharm
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : 1369-679
Functional Area : Compendial Development Laboratory
End Date : 15th April, 2019

Scientist in Synthetics Laboratory at USP @ Apply Now

Post : Scientist, Synthetics Laboratory

Job Description
This is a non-supervisory position responsible for the preparation of quotes for custom chemical synthesis projects and also for the synthesis and characterization of API impurities on milligram-to-multigram scale. The incumbent in this role will plan and execute diverse synthetic schemes to produce reference materials for supporting organizational business initiatives and RS material production.

Roles and Responsibilities:
• Responsible for carrying out literature search using various scientific data bases such as SciFinder and Reaxys, and design synthetic schemes to prepare target molecules
• Identify customer requirements from the inquiries shared
• Responsible for the making project proposals with cost estimates
• Perform wide range of critical reactions involving air sensitive and moisture sensitive reagents to synthesize desired compounds
• Optimize reaction conditions and apply purification procedures to produce quality products as per specifications
• Characterization of compounds based on analytical data such as IR, NMR, Mass Spectra
• Documentation of experiments conducted and the observation made as per QA guidelines
• Follow personal and lab safety guidelines

Candidate Profile
• PhD in Synthetic Organic Chemistry from a reputed research institute and/or M.Sc in Organic chemistry with not less than 4-6 years of work experience in CRO or Pharmaceutical Process R&D, or NCE R&D.
• Ability to carry literature search using scientific databases – Scifinder,and Reaxys etc
• Hands on experience in the synthesis, purification and characterization of wide range of organic compounds
• Expertize in designing synthetic routes for any given target molecule
• PhD with 1-2 years of work experience in CRO or Pharmaceutical Process R&D, or NCE R&D
• Sound knowledge in Synthetic organic chemistry and excellent skills in design of synthetic routes for target molecules
• Track record of producing structurally diverse compounds including heterocycles and macrolides
• Ability to work in a cross functional team environment
• Interpretation of Analytical data such as IR, NMR, Mass and HPLC
• Knowledge of Quality Management systems (ISO9001) or GMP
• Lab safety awareness and usage of PPE
• Basic written and verbal communication skills

Additional Information:
Location: Hyderabad, Andhra Pradesh
Education: M.Sc, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Job ID : 1220-679
End Date: 30th March, 2019

Require Bioanalytical as Manager at USP @ Apply Now

Post : Manager Bioanalytical

Job Description
This is a supervisory and hands-on position in USP-India’s Bioanalytical Laboratory in which the incumbent is responsible for contributing and managing activities carried out in bioanalytical function. The incumbent with their scientific knowledge and laboratory experience will contribute towards development of Reference Standards, Documentary Standards, USP’s programs and services and new global initiatives for Biologics product classes such as therapeutic proteins, monoclonal antibodies and peptides using USP’s standard setting processes.

Roles and Responsibilities
• Responsible to ensure that lab adheres to USP’s mission, goals and objectives. and complies with USP’s guidelines and other requirements.
• Contributes in development of Reference Standards, Documentary Standards, USP’s programs and services and new biologics global initiatives
• Perform technical supervision and managerial duties such as project updates, performance reviews, objective setting, staff development and career counseling for the team members.
• Review data, project reports, draft and review SOPs and other documents and ensure compliance to USP’s Quality Management System and contribute in ISO 9001 and ISO 17025 audits.
• Coordinates cross functionally in planning, implementing and evaluating laboratory procedures/systems on assigned projects.
• Performs other duties as assigned.

Candidate Profile
• D. with minimum 5 years of industry experience or M.Sc/M.Tech./M.Pharm in relevant stream of biological sciences with 8-10 years of industry experience working in Analytical R&D/QC department of Biopharmaceutical industry.
• Experience should include strong technical, practical and managerial experience in Bioanalytical area.
• The candidate should have expertise in method development and validation in Chromatography (HPLC/UPLC), Spectrometry and Capillary Electrophoresis based methods for Biologics product class. In addition, knowledge and practical experience in characterization studies for Biologics product class will be desirable.
• Strong scientific knowledge and working experience in analytical technologies such as Chromatography, Mass spectrometry, Capillary Electrophoresis, Circular Dichroism, Protein sequencing, MALLS etc. in the field of biopharmaceuticals as well as working experience of GLP, ISO 9001 and 17025 is required.
• Knowledge of USP documentary standards and reference standards for biologics is desirable
• Excellent presentation and communication skills required.
• An ability to communicate effectively with, both internal and external customers.
• Excellent people manager skill with a proven track record of effectively managing a team.

Additional Information
Experience : 8-10 years
Qualification : M.Sc/M.Tech./M.Pharm
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : 1303-679
Functional Area : Bioanalytical
End Date : 5th March, 2019

Apply for Scientist in Reference Standards Laboratory at USP

Post : Scientist I, Reference Standards Laboratory

Job Description
This is a non-supervisory position in Reference Standard Laboratory responsible for performing the required tests as a part of the project and maintaining the GLP environment in the Laboratory.

• Executing the analytical tests allotted by Project or Group Leader.

• Verification of test protocol and giving test kit approvals, if required.

• Supporting Verification, GPH, PQM and other departmental teams in terms of testing and project review whenever needed.

• Responsible for preparation of project evaluation reports.

• Responsible for sample tracking and chemical inventory tracking in the laboratory.

• Coordination with group leader to ensure completion of the projects allotted to the team.

• Initial review of the project reports and documents and assisting the group leader when required.

• Completing the project as per the timelines and trouble shoot the scientific aspects of the projects on need basis.

• Responsible for preparation and review of SOP’s protocols, reports etc.

• Responsible for performing the calibration of the equipment’s as per the schedule.

• Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.

• Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.

• Taking up any additional responsibilities assigned by group leader from time to time.

• Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification

Required Skills
Master degree in Chemistry with 1-3 years of relevant laboratory experience.
Proficient with pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP, FCC, NF, etc.).

Candidate Profile
Proven track record of consistently delivering projects on time and with high quality.
Expert in Chromatographic analysis, especially in HPLC and troubleshooting, proficient in other related analytical instrumentation (Titrations, IR, KF, UV, Thermal, Elemental analysis etc.),
Takes personal responsibility for delivery of projects to customers. Ability to embrace and lead change. Extremely adaptable.
Excellent communication skills, both written and verbal. Having knowledge of Empower software, ELN, ERP, QR coding system are added advantages.
Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.

Additional Information: 
Experience: 1-3 years
Qualification : M.Sc
Location: Hyderabad, Andhra Pradesh
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D

Require Senior Scientist in at USP (Verification Program)

Post : Senior Scientist I, Verification Program

Job Description
This is a key hands-on, non-supervisory position. In this role, the Scientist performs the required analytical tests of Verification samples using appropriate methods. The Scientist will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical support and knowledge. The Scientist has mastered many common techniques in the laboratory and is able to contribute their own observations and input to difficult projects. The incumbent will provide technical assistance to the Verification Program by performing analytical tests, reviewing analytical data and preparing summary reports. The incumbent may execute 80% - 100% of their work at the bench level.

Roles and Responsibilities:
• Executes the Verification projects by performing an individual analytical tests allotted by the Group Leader.
• Completes the projects as per the project timelines and priorities.
• Demonstrates solid scientific approach to analysis in the laboratory.
• Routinely applies personal experience, academic training, and technical insights – including emerging sciences – to solve complex technical problems within the laboratory.
• Presents technical seminars and lab demonstrations.
• Compiles project reports and responds QA observations.
• Executes all testing and analysis of data with excellence and essentially no errors;
• Demonstrates a strong desire to continue learning and grow personal capability;
• Pursues, recommends, and implements new approaches or processes to improve laboratory operations;
• Positively influences project direction by ensuring own work is congruent with overall direction of laboratory projects;
• Assists with other testing programs and housekeeping duties in the laboratory as needed.
• Prepares and reviews SOPs.
• Ensures the implementation of GLP, safety systems in labs.
• Ensures the calibration of the equipment as per the schedule.
• Indents chemicals, columns, Glassware, etc. and procures them by coordinating with lab operations and purchase department in advance keeping in mind the project deadlines.
• Ensures and follows USP mission, policies and procedures.
• Maintains good relationship with QA, HR, Purchase, accounting, IT and other dept.
• Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
• Supports collaborative testing, GPH, RSL and other departmental teams in terms of project testing, review, execution and approval whenever needed

Candidate Profile
• Ph.D. with minimum 5 to 7 years of relevant laboratory experience or Masters with 7 to 9 years of relevant laboratory experience.  Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical testing laboratory.
• Ability to lead projects to completion with a high degree of scientific expertise. Proficient with pharmaceutical testing requirements and test protocols involving compendial methods (USP, BP, EP, etc.). Expert in ICP, HPLC, GC, Dissolution analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, etc), strong communication and presentation skills, both verbal and written, experience working in the pharmaceutical industry strongly preferred. Should have very good skills to present the technical seminars and should participate in lab demonstrations. Knowledge of DEA, ICH guidelines and FDA regulations, and experience with compendial procedures and compliance strongly preferred. Proficiency with electronic documentation systems strongly preferred. Takes personal responsibility to ensure work is delivered on time and is the highest possible quality. Skills to anticipate, troubleshoot, and solve technical problems.

Additional Information
Experience : 5-7 years
Qualification : Ph.D, M.Sc
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : 1245-679
Functional Area : Verification Program
End Date : 25th December, 2018