Analytical Scientist

Philadelphia, PA, US • Posted 12 hours ago • Updated 12 hours ago
Contract W2
On-site
USD $37.86 - 42.86 per hour
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Job Details

Skills

  • Pharmaceutics
  • Research and Development
  • ELISA
  • Testing
  • Inventory Management
  • Process Engineering
  • Media
  • Inventory
  • Laboratory Equipment
  • Collaboration
  • Metrology
  • Forms
  • Workflow
  • Veeva
  • Document Management
  • Prism
  • Data Analysis
  • Documentation
  • Biology
  • Biomedicine
  • Cell Biology
  • Inspection
  • Molecular Biology
  • Biochemistry
  • Analytical Skill
  • Management
  • Communication
  • Research
  • Problem Solving
  • Conflict Resolution
  • GxP
  • Assays
  • Fluency
  • MEAN Stack
  • Customer Service
  • Training And Development
  • SAP BASIS

Summary

Software Guidance & Assistance, Inc., (SGA), is searching for an Analytical Scientist for a contract assignment with one of our premier Pharmaceutical clients in Philadelphia, PA.

Responsibilities :
  • Seeking an analytical scientist to support routine testing of gene therapy research and development samples and for authoring of technical reports for GxP studies.
  • Responsible for analyzing and reviewing data from protocol-driven studies to document results and conclusions in technical documents using Veeva.
  • Involve execution of analytical methods to support development and characterization of recombinant Adeno-Associated Virus (rAAV) vectors for gene therapy development.
  • Author and review technical reports for GxP studies and manage approval workflows in Veeva document management system.
  • Revise and manage approval workflows for SOPs and templates for calculation sheets and reagent preparation forms.
  • Perform routine compendial testing of vectors, process intermediates and reagents including endotoxin, bioburden, visual inspection, pH, and osmolality methods.
  • Perform routine testing of vectors and process intermediates in molecular assays (qPCR, dPCR), immunoassays (ELISA, gyros), and/or bioassays (in vitro potency) using automated liquid handlers (Tecan, Hamilton).
  • Prepare laboratory reagents and materials for use in routine testing.
  • Participate in sample management and cleanout activities, inventory management of reagents and materials, instrument maintenance, and verification/calibration of laboratory equipment.
  • Maintain good notebook documentation, perform data analysis, close-out experiments in a timely manner, monitor assay performance, and complete results/qualification reports.
  • Comply with all SOPs, policies, and laboratory safety procedures. This position requires good written and verbal communication skills and the ability to work effectively in a team environment is a must.
  • Hands-on execution of multiple manual and/or automated analytical methods such as compendial assays, molecular assays, immunoassays, and/or cell-based potency assays to support gene therapy research and process development.
  • Preparation of reagents, raw materials, and buffers/media for analytical methods
  • Manage inventory of lab reagents/consumables and participate in sample and lab cleanouts
  • Support maintenance and verification/calibration of laboratory equipment in collaboration with the lab automation and metrology teams.
  • Review recent and historical data from GxP studies to author technical summary reports.
  • Revise and manage SOPs and templates for assay execution such as reagent preparation forms, assay records, and calculation sheets.
  • Create, review, and manage approval workflows in Veeva document management system.
  • Use of analysis software such as SoftMax Pro, GraphPad Prism, and custom in-house developed spreadsheets to perform data analysis
  • Documentation of all experiments in electronic notebooks and/or technical reports
Required Skills:
  • A bachelor's degree or M. S. degree in biology, biochemistry, biomedicine, cell biology, or bioengineering.
  • Minimum of 1 year of relevant work experience is required.
  • Experience with compendial assays (endotoxin, bioburden, visual inspection, etc.) is required.
  • Describe critical skills and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • General scientific knowledge of cell and molecular biology, biochemistry, and related analytical methods.
  • Ability to learn new techniques and work independently once trained on protocols.
  • Strong organizational and time-management skills
  • Strong record-keeping and communication skills
  • Comfortable working in a fast-paced, high throughput lab environment.
  • Must value research integrity and collaborative research.
  • Complexity and Problem Solving
  • Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent's authority to make as well as those decisions that must be referred to a higher level.
  • Discuss process variations and/or out of range results with senior members of team and refer to policies/practices for guidance.
  • Exercise judgment within defined procedures and practices to determine appropriate action.
  • Must be comfortable in the fast-paced, biotech environment and interact with multi-Disciplinary teams Internal and External Contacts
Preferred Skills:
  • Experience with document authoring in a GxP setting is highly preferred.
  • Experience with molecular assays and/or immunoassays is highly preferred.
  • Experience with liquid handling automation platforms (Tecan Fluent, Hamilton STAR/Vantage, etc.) is a plus.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: sgainc
  • Position Id: 26-00656
  • Posted 12 hours ago

Company Info

About Software Guidance & Assistance

Founded in 1981, SGA is a technology and resource solutions provider with a national footprint and headquartered in the shadow of Wall Street. We’re a certified women-owned business. We provide contingent staffing, direct placement, and professional and managed services to transform businesses and evolve careers. We’re small enough to tailor our services to each client and big enough to deliver for some of the world’s largest employers. Our professionals are experts in areas such as IT, finance, accounting, risk, and clinical.

SGA provides contingent staffing, direct placement, and professional and managed services nationwide for Fortune 500 companies, mid-size businesses and select startups.

Our core skillsets include all areas of technology – business & data analysis, cyber & network security, database administration, development & architecture, infrastructure, program & project management, quality assurance & testing. We also deliver talent across professional business functions such as finance, accounting, risk, and clinical.

Our Professional & Managed Services team delivers IT projects through onshore, offshore and hybrid delivery models. We develop software products, modernize applications, add features, and integrate and maintain systems. Our scope covers, among others, complex application suites, data management and visualizations, machine learning and mobile applications.

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