20+ years of pharmaceutical and biotech experience, starting as laboratory technician up to scientist and technical writer; currently looking to stay in the biologics space in a documentation or training environment. In current role with BMS, oversaw new hires through new hire training while performing investigations for deviations.During tenure as senior technical writer at Lupin Pharmaceuticals, oversaw all documentation, revision, and filing across electronic and analog mediums.Extensive background in Research and Development (R&D), pre-formulation testing of APIs and other pharmaceutical formulations, overall Formulation and Development and data review.Fully versed in FDA/EU guidelines, DEA testing and inventory of formulations and APIs, Corrective and Preventive Actions (CAPAs), GLP/GDP/GMP, and Change Controls.

Preparation of specification, justification of specification, analytical methods, method validation protocols, summaries and reports, laboratory related SOP’s.• Maintaining the laboratory documentation, which includes but not limited to: • Inventory and maintenance of routine Laboratory raw data• Inventory and maintenance of Laboratory notebooks• Preparation of the documents for product filing like summaries, in-house certificate of analysis, statements and justification etc.•Organizing and maintenance of approved, archived and draft documents like laboratory SOP’s, analytical specifications, methods, technical reports, justifications, memo, track changes etc.•Initiation and tracking of change controls, deviations, CAPA, deliverable tasks for change controls etc.•Preparation of Inspection plans in SAP.•Coordinating with other departments and other locations for routing of change controls and filing of the products.•Maintenance of documentation related stationary and supplies.•Whenever necessary, travelling between company locations for above activities. Order necessary laboratory supplies.

•Responsible for the use and application of a variety of analytical instrumentation to support food product and process development. Specific instrumentation to include colorimeter, conductivity meter, pH meter, and various other analytical techniques related to color. Knowledge and comfort of use of HPLC. Knowledge with preparative HPLC and Agilent equipment .•Implements appropriate method modifications as required.•Validates new analytical methods.•Conducts additional laboratory procedures (analytical / standard preparation / sample preparation / shelf life protocol) depending on project demands as directed by an Analytical Laboratory Technician or Analytical Scientist. • Frequently resolves and or notes - inconsistent or atypical results in an independent manner.•Evaluates ongoing project laboratory needs on a daily basis. Schedules time and general-use lab equipment to meet project timelines. • Maintains documentation of analytical results in a company issued notebook and/or a Laboratory Information Management System (LIMS) depending on project format. • Maintains laboratory equipment and necessary supplies.•Knowledge of Laboratory Information Management (LIMS) systems. • Excellent practical laboratory skills. Ability to troubleshoot and maintain complex analytical instrumentation. • Knowledge and skill in the use of the following: Computers, Spreadsheet software (MS Excel preferred), and Laboratory Information Management Systems (LIMS). High performance Liquid Chromatography is a must. • Good organizational skills to adapt to fluctuating workloads while maintaining appropriate attention to detail.•Demonstrated ability to follow established laboratory safety procedures, to maintain accurate records, and to clearly and accurately read and write and transcribe data and analytical chemistry literature. •Good interpersonal skills with the ability to work independently or as a member of a team.

•Work under GLP/GMP regulations according to FDA regulations•Executes experimental studies intended to provide supporting data or to resolve technical issues encountered during each project. Defines technical objectives and conveys to other members of the team.•Represent the Oral solids Formulations Group at both internal team meetings and customer meetings relating to assigned projects that maybe of diverse scope (including other technologies).•Coordinates with Project Management, Analytical Services, Manufacturing, QC, QA, and other groups to ensure project requirements are met.•Resolves technical issues, makes recommendations for options that would resolve the issue, including a preferred option.•Works independently, supervised on a daily or weekly basis, recognizes key issues likely to affect successful and/or timely completion. For those issues that cannot be resolved, brings them to the attention of the person coordinating the work.•Executes technical activities involving active pharmaceutical ingredients that maybe potent or hazardous while following appropriate safety procedures.•Establishes work schedules in order to ensure timely completion of the required activities.•Proposes and implements recommendations to processes and procedures designed to increase efficiency, safety or quality.•Understands revenue associated with each project phase. Flexible with respect to Project priorities and ensures that site and/or departmental business objectives are met.•Completes technical activities, development reports and regulatory support documentation as required.•Maintains an awareness of current scientific practice that may have a relevance to the company.•Exercises judgment within generally defined practices. Acts independently on routine tasks and under general supervision on new assignments. Demonstrates potential for technical proficiency and scientific creativity.

•Work under GLP and GMP regulations according to FDA regulations•Works on problems of moderate scope where analysis requires in-depth evaluation of factors. Exercises judgment within generally defined practices. Acts independently on routine tasks and under general supervision on new assignments. Demonstrates potential for technical proficiency and scientific creativity.•Carry out activities and experiments in support of the development of pharmaceutical products under supervision of other scientists in the department. Strong HPLC analytical skills are essential, including experience with HPLC method transfer, development and trouble shooting, routine HPLC analysis of APIs and formulations, excipient compatibility testing, solubility measurements, and accelerated degradation studies. Experience of solid-state analytical methods are also required, including thermal analysis (DSC, TGA, TMA), X-ray powder diffraction, moisture absorption, particle size analysis and other bulk powder characterization methods.•Perform and support the development of products on a small-scale in the laboratory. This includes development of simple pre-clinical and early clinical formulations, conducting processing studies, and evaluating formulation performance.•Keep accurate and detailed records of experiments including results and conclusions.•Provides written and verbal updates on projects and activities as required.•Assist others, as necessary, for timely project completion and supervise other lab personnel as required.•Comply with Health, Safety and Environmental responsibilities for the position.

•Manufactures formulations with multiple concentrations of solutions, suspensions, capsules, and feed admixtures for non-clinical safety studies to meet toxicology schedules.•Work under GLP and GMP regulations according to FDA regulations.•Provides samples of manufactured formulations for chemical analysis.•Develops formulation procedures (chooses methods, equipment, vehicles, carriers, etc.)•Process validates experimental procedures. Operates, calibrates, and is thoroughly familiar with lab equipment.•Accounts for all tests article/control articles including the procurement, documentation, dispensing, and inventory.•Prepares, documents, distributes, and inventories the non-clinical formulation•Understands and performs pharmaceutical calculations.•Performs in process data audits of batch records and completed manufacturing procedures generated by peers and subordinates.•Writes and computer generates batch records with moderate supervision.•Uses appropriate pharmaceutical procedures and scientific terminology.•Identifies/recommends new technologies as appropriate, participates in upgrading of existing/previously established methodologies.•Performs final data audits of formulation records and completed manufacturing procedures generated by peers.•Independently produces summaries of work which reflect an appropriate understanding of formulation manufacturing and laboratory goals.•Participate in QA inspections (as auditor).•Assists in training of new employees, when applicable.

•Schedules, performs and documents analysis and uniformity tests on solutions and injectables for short-term studies and test substances/feed mixes for long-term studies in accordance with protocols, GLP regulations and laboratory safety requirement.•Validates and develops methodology where required. Conducts stability testing where necessary. •Operates, maintains and calibrates analytical equipment.•Takes part in writing of reports and record keeping, and other technical and administrative activities required for the operation of the Analytical Chemistry Laboratory.•Work and arrange own time schedule, ensuring timely testing of samples.•Reviews data generated by other team members. Report results in a timely manner and meet deadlines.

•Sample initiation in Lab Manager and Beckman LIMS Dictionary maintenance for various departments. Assist various departments in Expert Ease Dissolution program. Assist in the training of employees in the Expert Ease/LIMS Interface programs. Assist in balance interface programs with Expert Ease/LIMS interface programs.•Trouble shoot Expert Ease Dissolution program and Validate Expert Ease/LIMS interface programs. Entry of stability data into LIMS program.•Testing of drug substances, solutions and suspensions used in the dosing of the animals•Work under GLP regulations according to FDA regulations.•Purity testing for drug substances, L.O.D. analysis by using a T.G.A. and Optical Rotation instrument. Work and arrange own time schedule, ensuring timely testing of samples•Report results in a timely manner and meet deadlines.