Analytical Method Validation (AMV) Scientist

Company: Torrent Pharma Inc.
Location: Levittown
Posted on: February 22, 2021

Job Description:

**This role requires candidates to be located in or around Levittown, PA**Torrent Pharma Inc. is a multi-billion dollar company leading the way across the globe within the Biotech and Pharmaceutical industry. With a significant presence in over 40 countries, Torrent Pharma Inc. is looking to continue expanding its US base further. Torrent is seeking a qualified AMV Scientist to join our Quality Team in Levittown, PA.Essential Duties and Responsibilities:* Daily set-up, operation, troubleshooting and maintenance of instrumentation such as HPLC, UPLC, UV, GC, KF, FTIR, and IC in accordance with written SOPs* Provides technical project leadership, participating in protocol development and execution for test method validation / verification and related activities* Provide expert level troubleshooting of laboratory equipment methods and process* Maintain lab work area and documentation in a neat and orderly fashion* Maintain data within a laboratory notebook in a legible, organized, and compliant manner, and transcribes or enters data into necessary records in an accurate and timely manner* Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management promptly for further investigation.* Performs investigative testing or other functions to assist with laboratory investigations.* Assists in execution of training and acts as a mentor to less-experienced analysts.* Works in support of production and development projects and may require weekend, off-shift work, or overtime as necessary to complete high priority work assignments* Interacts regularly with other departments including R&D, RA, and QA to ensure priorities are aligned and products are on track.* Reviews procedures and completes required documentation or updates as appropriate as part of Periodic review process* Performs laboratory testing of Raw materials, In-process, Finished product, and Stability samples for potency and physical characteristics in accordance with company SOP's as well as cGMP's* Manages projects to improve Laboratory compliance and efficiency.* Works on development products, methods and projects to support R&D initiatives* Works with computers as well as laboratory software, or proprietary software as neededADDITIONAL RESPONSIBILITIES:* May require technical review of previously generated data for Regulatory responses.* Responsibilities for the appropriate documentation and disposal of unused laboratory samples and expired reagents.* Maintain and demonstrate a high level of personal and professional integrity and Report any suspicious activity to laboratory management.* Assists Laboratory Management on special projects and assignments* Additional responsibilities may be assigned by Laboratory Management as neededQUALIFICATIONS:To perform this job successfully, an individual must be able to perform each essential Duty satisfactorily. The requirements listed are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Competencies/Skills: * Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.* Proficient in technical writing* Strong organizational skills and the ability to multitask* Demonstrated ability in working independently and as part of a team* Must be able to work in a cross-functional environment interacting with other internal departments and external vendors* Excellent communication (oral and written) and interpersonal skills* Must be able to communicate technical, scientific, and regulatory information, both written and verbally* Proficient knowledge USP and ICH guidelines of method validation and verification* Ability to work in a detail-oriented manner* Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.* Must have a teamwork attitude* ability to apply common sense understanding to carry out multi-step instructions* deal with standardized situations with occasional variables* ability to interpret data utilizing intermediate math operations; perform complicated analytical calculations and statistical analysis* ability to read and comprehend instructions in the English language through verbal and written methods.* ability to write or speak in the English language and communicate information effectively in one-on-one and in a group of employees within the organization.Education and/or Experience: * B.S. or higher in Science Field, Chemistry Degree Preferred.* 10 or more years of demonstrated excellence in the field of analytical chemistry.* 5 or more years of experience in method validation/ verification* Demonstrated technical expertise in instrumental laboratory analysis.* Prior experience in a pharmaceutical (cGMAP) laboratories setting is required* Prior Project management experience preferred

Keywords: Torrent Pharma Inc., Levittown , Analytical Method Validation (AMV) Scientist, Other , Levittown, Pennsylvania