Lead a team of software developers and researchers to implement requirements, develop user interfaces, and algorithms. Analyze, design, program, test and implement application software involving mathematical and physics related formulas and calculations. Make detailed plans to accomplish goals & direct the integration of technical activities, analyze information & evaluate the results to choose best solution, identify information by categorizing, estimating, develop specific goals/plans. Develop client server and web applications using VB and/or C#, ASP.net, HTML/XML, and SQL Server 2000. Perform Database Design, develop queries, sub queries, joins, integrity constraints, triggers, stored procedures, and unit testing of the functionalities. Network & Database Administration, Windows 2000 Server Administration, SQL Server Administration. Document UI specs & design Sequence, Data flow & Class diagrams. Configure and maintain LabTech Data Acquisition systems for product temperature and stability studies. Design, develop and implement reporting and analysis environment, including template-driven and parameterized reports. Develop ad hoc interfaces enabling users to generate their own reports. Provide technical support for Systems Integration and Acceptance testing. Provide production support. Development platforms: Windows XP Windows 7.

Requires Bachelors or foreign equivalent in Computer Science, Engineering(any) or closely related field, and 5 years experience in the job offered or related technical role. 5 years experience should be with progressively higher responsibilities. Masters with 3 years experience can be substituted for Bachelors with 5 years experience. 1 year experience in (A) maintaining user interfaces using VB and/or C#, and related technologies; (B) developing/coding applications with mathematical & physics related formulas; (C) maintain/supporting reporting and analysis environment, including template-driven and parameterized reports using Crystal Reports for windows and web applications; Strong skills in Network & Database Administration, Windows 2000 Server Administration, and SQL Server Administration; Experience can be concurrent; and Employer will accept any suitable combination of education, training or experience that is equivalent to the actual minimum requirements of the position & shows demonstrable ability in skill sets required for the position.

Plan, coordinate, supervise and control Packaging and Labeling activities in an orderly fashion, ensuring that it is performed in compliance with applicable regulatory standards including current Good Manufacturing Practice (cGMP) regulations 21 CFR Part 210 and 211 and applicable SOPs. Review physicochemical properties of pharmaceutical formulations. Design & develop container closure systems for primary and secondary packaging of pharmaceutical formulations. Design & develop pharmaceutical labels in compliance with global regulatory requirements for used in different countries for investigational use. Maintain & monitor Packaging and Labeling facility, ensure that all Packaging and Labeling equipment of qualified and calibrated prior to use in operations. Prepare and execute packaging and labeling batch records, develop packaging and labeling manufacturing procedures and preparation of respective SOPs. Monitor release of packaging components prior to use in Packaging and Labeling facility. Review Client protocols, interact with Client representatives in obtaining packaging and labeling requirements, design and develop packaging configurations, and draft labels for investigational agents to assure patient compliance.

Requires Bachelors or foreign equivalent in pharmaceutical Sciences or Chemistry, and 5 years experience in the job offered or related technical/analytical role in manufacturing. 5 years experience should be with progressively higher responsibilities. Master's degree with 3 years experience can be substituted for Bachelors with 5 years experience. (1). 2 years experience in Clinical trials, Validation techniques & development of pharmaceutical formulations. (2). Congnizance of manufacturing SOPs & manuals; packaging regulatory requirements with special emphasis on pharmaceutical products intended for investigational purposes; and applicable International Standards/Regulations/Laws relating to operations and safety. (3). Experience can be concurrent; and (4). Employer will accept any suitable combination of education, training or experience that is equivalent to the actual minimum requirements of the position and shows demonstrable ability in the skills required for the position.

Manage patient specific Confidential Data Management, report generation and label printing operations. Manage and maintain Investigational Drug Management/System (IDMS); Pharmacy (Rx) System; Clinical Randomization Scheme Generation. Generate Clinical Randomization Schemes for various clinical studies supported by the company. Maintain in-house developed and client supplied clinical randomization databases in Oracle and MS SQL Servers. Generate and print patient specific study product labels from the secured clinical databases in Oracle and MS SQL data servers. Write application queries to generate reports for clients with patient specific clinical randomization data. Prepare requirements, test cases, and validation protocols for all the applications developed in house relating clinical randomization scheme generation and reports. Develop, maintain, and test Disaster Recovery Management Program for company facilities addressing all aspects of Risk Management to include systems back-up and restoration, facilities relocation, and emergency preparedness. Work with Manager, QA/QC in the development of Software Validation Protocols and Revision Control Procedures.

Requires Bachelors or foreign equivalent in Computer Science, Engineering or closely related field, and 5 years experience in the job offered or related technical/analytical role. 5 Years experience should be with progressively higher responsibilities. 1 year experience with Oracle, MS SQL, Visual Basic 6.0, VB.Net and tools such as Test Quest Pro, Visual Source Safe and Mercury. Experience can be concurrent.

Develop procedures for validation, qualification, calibration and maintenance of various test and operating equipment traceable to NIST standards. Perform design, operation, and performance qualifications on various test equipment; perform facility temperature mappings and equipment validations /periodic calibration; implement calibration schedules and coordinate with third party vendors to ensure that all equipment are calibrated in timely manner. Maintain the hard ware of Data Acquisition Systems (DAS) and calibration of DAS boards. Programming to be performed using VB 6.0, ASP, COM+, JSP, J2EE, VB ActiveX, ADO, SQL Server 2000 for design and maintenance of data acquisition and instrument control. Implement physical security of company's facilities, disaster recovery program, health and safety. Maintain HVAC Systems. Assist in performing in-process testing during manufacturing and packaging and labeling.

Requires Bachelors or foreign equivalent in Science or Engineering, and 5 years experience in the job offered or related technical/analytical role. 5 years experience should be with progressively higher responsibilities. Master's degree with 3 years experience can be substituted for Bachelors with 5 years experience. (1) 2 years experience in instrumentation control, calibration and data acquisitions; (2) Cognizance of SOPs and Manuals; Good Manufacturing Practice (cGMP) regulations; federal, state, and local regulations pertaining to operations, administration, maintenance & safety of test and operating equipments; (3) Experience can be concurrent; and (4). Employer will accept any suitable combination of education, training or experience that is equivalent to the actual minimum requirements of the position and shows demonstrable ability in the skills required for the position.