Wednesday, 22 April 2015

Research Scientist- Microbiology & Genetics/biotechnology-Bhopal

Job Description

 
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Job Summary

Research scientist will work in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success. This candidate will use their skills and knowledge in Microbiology, Genetics, Molecular Biology, Virology and Bacteriology to develop and optimize new products.

Job Description

- Design, execution and coordinate in vitro enzymatic and cell based assays.
- Manipulate microbial genetic material for the development of new products.
- Develop and perform small scale fermentation studies.
- Conduct analysis of pharmaceutical and biologic products using traditional microbiological techniques such as dilution, pour plating, and filtration.
- Perform a wide range of general Microbiology and Molecular testing to include: PCR, PCR design, primer design, PCR optimization, DNA extraction from bacteria, DNA sequencing, DNA gel electrophoresis, protein extraction, BCA assay, PAGE, Western blotting, Western blot optimization, silver staining, antibody sourcing, bacteriology and fermentation.
- Candidate may also perform: cloning, subcloning, restriction digests, ligations, transformations, Southern blots and protein expression.
- Culturing bacterial and mammalian cell lines. Collect, analyze and present data at both internal meetings with other scientists and collaborators as well as at external scientific meetings.
-Perform program/project management tasks to facilitate pre-clinical to clinical development of vaccine candidates.
- Interface with external research collaborators to manage pre-clinical research studies.
- Responsible for preparation of study protocols, reports and reports for regulatory filings for product development.
- Monitor critical study phases at CROs to ensure protocol adherence and compliance with GLP standards, as necessary.
- Prepare study design, study data, and program updates.
- Work with cross functional development group to bring research stage molecules to market.
- Independently review the scientific literature for advances in product development.
-Assist in preparation of Preclinical study design and Plans.
- Analysis of the data from those studies.
- Review reports for finalization.
-Capable to write up of manuscript and publish the research work.

Desired Candidate Profile

Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy, M.Sc - Bio-Chemistry, Biology, Microbiology
Doctorate:Ph.D - Pharmacy, Bio-Chemistry/Bio-Technology, Biotechnology, Microbiology
 

Preclinical Research Scientist-Bhopal

Job Description

 
Job Summary

Preclinical research scientist will work in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success. This will include establishing the capabilities for testing of products in preclinical models and/or managing CRO studies aimed at providing proof of concept.

Job Description

- Design, execution and coordinate in vitro/ in vivo Pharmacology, DMPK & Toxicology studies including critical tips/suggestions in life phase of experiments, cross checking the raw data files, draft and final report reviewing and discussing the study results to intra- department teams, and project team members.
- Develop in vitro and in vivo animal model systems and techniques to evaluate efficacy and mechanism of action of nutraceuticals/pharmaceutical products.
- Monitor critical study phases at CROs to ensure protocol adherence and compliance with GLP standards, as necessary.
- Present study design, study data, and program updates.
- Support integrated project goals; pro-active role for departmental budget and timeline commitment, provide technical and professional advice to junior scientists.
- Work with cross functional development group to bring research stage molecules to market.
- Independently review the scientific literature for advances in model development.
-Assist in preparation of Preclinical Safety Development Plans.
- Analysis of the data from those studies.
- Review reports for finalization.
-Write up of manuscript and publish the research work.

Desired Candidate Profile

Education-
UG: B.Sc - Bio-Chemistry, Biology, B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy, M.Sc - Any Specialization, Bio-Chemistry
Doctorate:Ph.D - Bio-Chemistry/Bio-Technology, Biotechnology, Pharmacy

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Research Associate -analytical Formulations @ Alembic Research Centre

Job Description 
1. Development of analytical methods such as Assay, Related Substances, Dissolution for new formulations for solid orals formulations.
2. Identification of unknown impurities in stability samples using LCMS/MSMS
3. Responsible for resolving issues occur during routine analysis and stability studies.
4. Generation, isolation and charactisation of unknown impurities crossing identification threshold using LCMS.
5. Complete analysis of generic drug products targeted for US,UK market.
6. Trouble shooting in method development.
7. Calibration of analytical Instruments i.e. LCMS, HPLC, UPLC.
8. Preparation of method transfer sheets and standard test procedures.
9. Ensuring regulatory compliance by maintaining of appropriate requisite documentation/record

Experience 2 - 5 Years
Industry Type Pharma / Biotech / Clinical Research
Role Analytical Chemistry Associate/Scientist
Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Education UG - B.Sc - Any Specialization, Chemistry, B.Pharma - Pharmacy
PG - M.Sc - Any Specialization, Chemistry, M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Compensation:  Not disclosed
Location Vadodara/Baroda
Keywords Assay Dissolution Method Development
Contact Human Resources
Alembic Pharmaceuticals Limited
Website http://www.alembic-india.com
Job Posted 2015-04-21 12:12:04.0

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Research Executive (Phd Organic Chemistry)-Mumbai

CTC : 3,50,000 - 6,00,000 P.A 

Job Description

 
    Running & monitoring chemical reactions, work up, isolation and characterization of products.
    Synthesis of various multi step agrochemicals/PGR/intermediates
    Maintaining chemical inventory, taking care of lab, equipment's/instruments 
     

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Manager Global Primary Research - Noida

CTC: 7,00,000 - 12,00,000 P.A 

Job Description

 
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  • Responsible for healthcare / pharmaceutical / medical devices primary research operations end to end
  • Managing and mentoring a team of analysts/lead analysts for various global telephone primary research projects
  • Responsible for managing top lines and bottom lines for healthcare primary research vertical
  • Responsible for smooth delivery of primary research projects end to end
  • Manage client accounts from a relationship perspective
  • Drafting project scope (business proposal) as per client's requirements, studying, analyzing and estimating effort required for execution
  • Understand research objectives based on client type and accordingly design/define the work approach; project scope and timelines
  • Develop work plan for projects with a visibility on client engagement process, interim deliverable, etc. in an organized manner as per prioritization
  • Responsible for the quality of the work being done in the team; review work thoroughly to ensure consistently high quality output, value addition and adherence to timelines; be able to judge required level of own involvement on projects, execute parts of projects if situation so demands
  • Provide analysts with effective verbal/ written feedback; counsel analysts on technical as well as business skills and guide them on best practices
  • Contribute to different organisational tasks such as hiring, training and other organisational initiatives
Desired Candidate Profile
  • Strong educational background in pharmacy, biotech, life sciences, biomedical or clinical research
  • 2-3 years of experience in managing teams and projects for healthcare/pharma primary market research through CATI (Telephone)
  • Demonstrated skills in both people management and client management
  • Experience in business development is a plus
How to Apply?
Email your resume with Subject : Manager Global Primary Research (Healthcare, pharmaceuticals, medical devices) - Noida (Job Id : 2283) to : jobs@thesearchhouse.com

After Emailing your resume you may call : 9811112343

View more jobs matching your profile on The Search House website. http://www.thesearchhouse.com


Desired Candidate Profile

Education-
UG: B.Tech/B.E. - Any Specialization, B.Pharma - Pharmacy

Recruiter Name:Jyoti
Email Address:
Website:http://www.thesearchhouse.com
Telephone:9811112343

Research Associate/ Content Writer-Hyderabad / Secunderabad

CTC: 1,50,000 - 2,00,000 P.A

Job Description

    • Content writing for spectrum / Pharmaplus books
    • Preparing copy right free material/ books.
    • Preparing Content for MBA, B.Tech (all streams), Competitive books/ Materials.
    • Content to be written in easy, meaningful and as per the requirements of the students.

Desired Candidate Profile

UG: B.Tech/B.E. - Any Specialization, Civil, Computers, Electrical, Electronics/Telecommunication, Mechanical, B.Pharma - Pharmacy, B.Com - Commerce
PG:MBA/PGDM - Finance, HR/Industrial Relations, Marketing, M.Tech - Any Specialization, M.Sc - Any Specialization, Chemistry, Maths, Physics, M.Pharma - Pharmacy

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Research Associate - Analytical R&D ( Male )-Hyderabad / Secunderabad

CTC: 1,00,000 - 4,00,000 P.A 

Job Description

 
Knowledge of analytical method development, Validation and stability analysis of Oral and Injectable dosage forms.
Handling of dissolution apparatus for Tablets, Capsules, Oral Liquids and Oral Suspensions.USP Type-I, USP Type-II & USP Type-IV.
Knowledge about the handling of analytical instruments like HPLC,GC, UV,SOR,IR,Particle size analyser,Osmometer,viscometer etc.
Knowledge about the calibration of HPLC,GC,UV,SOR,IR,Particle size analyser,Osmometer,viscometer etc.
Knowledge about regulatory guidelines and requirements.
Knowledge about method transfer activities.
Knowledge about the safety aspects.
Knowledge about GLP and GMP.
Knowledge about the qualification of equipment and instruments.
Qualification M.Pharm./M.Sc. (Analytical Chemistry/Organic Chemistry)
Forward CV's : ideal9@idealconsultants.com/ call at 9989059750

Research Associate - Formulation R&D ( Male )-Hyderabad / Secunderabad

CTC; 1,00,000 - 4,00,000 P.A 

Job Description

 
Knowledge of Oral and Injectable dosage forms.
Handling of Tablets, Capsules, Oral Liquids and Oral Suspensions.
Handling of Injectable Liquid and Lyophilized Formulations.
Knowledge about the handling of Cytotoxic materials.
Knowledge about the safety aspects.
Knowledge about GLP and GMP.
Knowledge about the qualification of equiment and instruments.
Knowledge about regulatory guidelines and requirements. Candidate Should have experience in pharma Industry
Qualification M.Pharmacy (Pharmaceutics/Industrial Pharmacy)

Forward CV's : ideal9@idealconsultants.com/ call at 9989059750

Research Associate/sr. Research Associate - Bio Analytical-Macleods Pharmaceuticals Ltd.-Mumbai

CTC : 2,00,000 - 4,00,000 P.A 

Job Description

 
Bio-analytical method development and method validation using LC-MS/MS.
LC-MS/MS method development
Data analysis and report preparation of Bio analytical and ADME studies
Documentation and accountable for overall scientific data and reports
Review of Method Validation reports and Bioanalytical report

Desired Candidate Profile

Education-
UG: B.Pharma - Pharmacy
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required, M.Pharma - Pharmacy

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J&J to increase wearable insulin patch-pump production

Johnson & Johnson will scale up manufacturing of a three-day wearable patch pump used to deliver insulin, in preparation for a post 2016 launch.

Anti-fungal shows promise for cancer breakthrough in preclinical tests

An anti-fungal drug shows potential to treat a range of cancers, according to research from the Repurposing Drugs in Oncology (ReDO) project, but the drugmakers will need a financial incentive to pursue a licence for new indications.

PPD pushes further into Asia with new Chinese central lab

CRO Pharmaceutical Product Development (PPD) has opened a central laboratory in Shanghai, China, in order to meet growing client demand for scientific and technical services there.
PPD pushes further into Asia with new Chinese central lab

HLS and Harlan create hairless mouse model

Huntingdon Life Sciences and Harlan Laboratories have launched a highly immunocompromised hairless mouse model for oncology and immunology research.

Read More at

Tuesday, 21 April 2015

Get Certification and Experience together - Get employed with Drug Development Org.

https://docs.google.com/forms/d/17B1o8qnDipYPw5gpaNaKygwPG37rGuVb9ZxI7Yny4qA/viewform

Clinical Data Manager I-Bengaluru/Bangalore-PPD

ob Description The objective of a Clinical Data Manager I is to act as the lead data manager for one or more projects or to provide support to the lead data manager. CDM I's will lead all data management activities for individual, limited volume/complexity studies with mentoring from a manager as required. CDM I's work independently and efficiently perform, with quality, all data management activities within an assigned study. CDM I's may mentor junior level staff on all associated tasks within a study. CDM I's liaise with the sponsor as required and communicate with management regarding all data management activities within their studies. Responsibilities include:
Ensures database accuracy according to departmental operating procedures
Performs a QC review of the data and makes corrections to the DM database
Develops data validation manual
Defines and tests databases and data validation system
Represents Data Management in all cross functional meetings relating to the study
Reviews data listings for consistency and accuracy of data
Develops and maintains data management project documentation files
Performs independent reviews of data management deliverables following documented guidelines
Acts as an interdepartmental and sponsor liaison for all DM study activities
Produces project-specific status reports for management and sponsors
Monitors study metrics
Analyzes and resolves discrepancies in data validation or other reports

Education and Experience:
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Minimum 3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience
Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily

Desired Profile

Education:UG -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
 

Clinical Research Coordinator-SMO Connect Clinical Research Services Pvt Ltd -Chennai, Coimbatore, Salem

Job Description

 
Job description:

1. Maintaining the source documents, CRFs, Investigator Site File and other study related documents according to ICH-GCP guidelines.
2. Completing the eCRF.
3. Maintenance of Investigational Product according to the specific temperature.
4. Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits.
5. Organizing ethics committee meetings.
6. Completing the review forms and submitting all study related documents to EC.
7. Coordinating with the local labs, central labs.
8. Assistance in Safety Reporting within the required timelines.
9. Assistance in patient selection and recruitment. .
10. Assistance in Informed Consent Process.

Desired Candidate Profile

Education-
UG: B.Tech/B.E. - Any Specialization, Bio-Chemistry/Bio-Technology, B.Sc - Any Specialization, Microbiology
PG:M.Sc - Any Specialization, Microbiology, M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology

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Post of Clinical Data Coordinator- Post of Clinical Data Coordinator i Clin Research Solution Pvt Ltd -Bengaluru/Bangalore, Chennai, Hyderabad / Secunderabad

Job Description

 
Individual Case Safety Report Processing,
End to End CDM activities
Relevant experience in ClinicalDataManagement (Mandatory Rave/OC)
Perform datamanagement activities on the assigned project in a timely and efficient manner

Desired Candidate Profile

Education-
UG: B.Tech/B.E. - Any Specialization, Bio-Chemistry/Bio-Technology, Computers, B.Sc - Any Specialization, Bio-Chemistry, Biology, Computers, Microbiology, B.Pharma - Pharmacy, BDS - Dentistry, BHM - Hotel Management, MBBS - Medicine, BVSC - Veterinary Science, BCA - Computers, B.A - Any Specialization
PG:M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, Computers, MCA - Computers, M.Sc - Any Specialization, Bio-Chemistry, Biology, M.Pharma - Pharmacy, M.S/M.D - Any Specialization, MVSC - Veterinary Science, M.A - Any Specialization

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Trainee (For Freshers Only) - Clinical Research (0-1 Years) - 50 Opening(s)-Pune

Job Requirements:
Candidates with diploma/course in Clinical Research will be preferred.
Clinical Research subject knowledge
Good Communication Skills
MS Office knowledge
Willingness to work in Night Shifts
Freshers only

Walkin details:
Date-22nd April to 23rd April , Starting Time: 10 AM 
Contact person : Vishal Salve
020-30615000  
Interview Location : Syntel Ltd,Talawade Softeware Technology Park, Talawade, Pune
UG - B.Tech/B.E. - Agriculture, Bio-Chemistry/Bio-Technology, B.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, General, B.Pharma - Pharmacy, BDS - Dentistry, BVSC - Veterinary Science
PG - M.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, M.Tech - Agriculture, Bio-Chemistry/Bio-Technology, M.Pharma - Pharmacy
 

Sr. Pharmacovigilance Physician-Quintiles-Bengaluru/Bangalore

Job Description

 
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 PURPOSE Apply knowledge and expertise including complex decision making activities to review, assess and process Lifecycle Safety data and information across all service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.

RESPONSIBILITIES
Receive, triage, review and process Lifecycle safety operational data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission.
Assess Lifecycle safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.
Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting operational data.
Process Lifecycle safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
Build a positive, collaborative team environment with Lifecycle safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations with appropriate allocation of resource.
Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
Provide and impart technical and process information to Lifecycle Safety Management (LSM) and members of operational team on project specific issues.
Provide oversight and maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
Establish and maintain effective team project service operations communications i.e. provide regular feedback to operations team manager and Customer Delivery manager (CDM) on project metrics, out of scope work challenges/issues and successes; feedback effective project performance to junior members of team.
Liaise with LSM contact in proactively identifying issues and proposing solutions, providing them with technical support, reports, metrics, statuses, identifying SOW changes and potential change orders ,delegating client requests and installation of new initiatives.
Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
Participate in training across Lifecycle safety process service offerings, participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
Liaise confidently with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues.
Contribute to achieving productivity utilization and realization metrics.
Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required.
Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
Perform other duties as assigned.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

In depth knowledge of Lifecycle safety processes and willingness and aptitude to learn new skills across Lifecycle safety service lines.
In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
Proven ability to meet strict deadlines; manage competing priorities.
Demonstrate effective project management and leadership skills.
Sound judgment; independent thinking and decision making skills.
Demonstrate a flexible and receptive approach to changing demands.
Proven ability to work independently and autonomously with policies and practices.
Effective mentoring and coaching skills.
Excellent attention to detail and accuracy maintaining consistently high quality standards.
Excellent organizational skills and time management skills.
Excellent written/verbal communication and report writing skills.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to work effectively on multiple projects simultaneously organize own workload and effectively manage competing priorities.

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Safety Associate I-Pune, Hyderabad / Secunderabad-inVentiv Health

Job Description
Responsibilities

Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance

Prepare safety data reports for submissions to clients

Prepare expedited Safety Reports for submission to Regulatory Authorities

Assist in representation of Global Safety and Pharmacovigilance group at project team and client meetings

Communicate with Clinical Operations and clients to ensure compliance with safety and Pharmacovigilance SOPs

Assist in compilation of regulatory submissions, i.e., Annual Reports Periodic Safety Update Reports

Assist the safety lead for projects; to include set up , project management, client liaison

Perform literature searches

Assist with SAE reconciliations

Desired Profile
Requirements

Bachelors Degree in a life science or nursing; or RN diploma; in Lieu of degree a total of four years relevant experience may be considered.

One year relevant experience in Safety/Pharmacovigilance required which may include up to 2 years of data management, CRA, clinical practice (RN, RPN). Health authority of study coordinator experience

Good Verbal and written communication skills

Good Knowledge of ICH guidelines and regulations relating to Safety Reporting
Education:UG -Diploma - Any Specialization, B.Sc - Any Specialization, Nursing
PG - Any Postgraduate


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