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Reference # : 19-241317 Title : Scientist
Location : Gaithersburg, MD
Experience Level : Start Date / End Date : 09/16/2019 / 03/15/2020  
Description
I'm a recruiting consultant with Artech and I'm hoping I can help you find the perfect next opportunity for your career goals. You very well could be happy in your present role, but might be looking for a more challenging project or maybe you want to explore opportunities outside your comfort zone.  I am currently recruiting for a Scientist for one of the largest Pharmaceutical Company in the US.  Below are the specs for the role:
 
Job Title: Scientist
Location: Gaithersburg, MD
Duration: 6-12 months; possibility of extension past that
 
Job Summary:
 
Job Description:
  • The Scientist role will be associated with Drug Delivery group in Dosage Form Design and Development department of Biopharmaceutical Development organization.
  • In this position you will closely work with the CMC lead to advance products through early-to-late stage development to support phase 1 to 3 clinical trials. In this role you will engage with network of contract manufacturers (CMOs) of excipients, critical pharmaceutical ingredients and drug products to assure materials are delivered with quality and to regulatory requirement to support appropriate phase of the clinical trial.
  • You will possess biopharmaceutical scientific expertise of solid-state materials to identify their critical properties and their quality attributes that will control quality and performance of final drug product.
  • You will also possess technical expertise in manufacture of solid materials and/or solid oral drug products to identify critical process steps and parameters that will help improve manufacture process, scalability and reduce costs.
  • You will manage and provide oversight for activities at CMOs to streamline operations for deliverables meeting tight timelines. You possess a demonstrated understanding of GMPs and regulatory guidance’s (ICH, FDA, EMA, etc) for manufacture activities.
 
Responsibilities:
  • Solid state material characterization to identify critical parameters that set the quality and governs optimum and consistent dug product performance.
  • Identify critical steps in the manufacturing process that controls material polymorphs, reproducibility and scalability.
  • Identify critical quality attributes of materials/drug products to set clinical phase appropriated specifications.
  • Set materials on stability to evaluate quality and shelf life of the material
  • Identify solid forms with different properties to overcome development challenges.
  • Review technical documents, progress reports, specifications/COAs from manufacturers or suppliers and keep abreast with development activities.
  • Align with different CMC functions - regulatory, quality, analytical, formulation – to deliver material/product with phase appropriated quality.
  • Timely communication of important and critical issues arising from suppliers to CMC lead and the team with clear details and potential solutions.
  • Understand manufacturing process to identify critical process parameters to support process improvements, reproducibility and cost reduction.
  • Attention to details and quick response to new developments during processes. Managing competing priorities in a fast phase development timeline.
  • Manage and stay on top of material related quality investigations, working with functions to take steps to trouble shoot and close investigations timely manner.
  • Manage materials to support various needs and suppliers in setting up/renewing contracts as required, issuing new purchase orders routing for approval through management chain.
  • Develop material manufacture and use history for traceability. Manage material shipping and receiving by working closely with LCS (logistics and clinical supply) team.
  • Help drafting of technical sections of regulatory submission documents related to materials and products, EOP2 briefing documents and questions/answers to various agencies.
  • Assess current product quality and devise phase 3 enabling material development plan.
  • Work with material sourcing group to identify and screen suppliers, develop materials to set quality/specification. Identify steps to reduce cost.
  • Involve in setting process parameter range and validation of manufacture process technology transfer
 
Qualifications and preferred skills:
  • PhD/MS/BS degree in chemistry, material science, pharmaceutical or related physical or life science discipline and 3-10 years of relevant experience related to pharmaceutical development.
  • Experience in pharmaceutical product development in solid oral dosage forms.
  • Possess technical knowledge of biopharmaceutical properties of critical material.
  • Understand critical quality attributes of each material in drug product performance.
  • Ability to assess the risks of a situation, their potential impact on a project and timely communication with internal and external partners.
  • Experience in scalability assessment and trouble shooting.
  • Verbal and technical writing skills.
  • A flexible attitude with respect to work assignments.
  • Excellent analytical and problem-solving skills.
  • Excellent organizational skills and managing of multiple suppliers.
  • Knowledge and understanding of current Good Manufacturing Practices (cGMPs).
  • Proficient in MS suite of software tools (PowerPoint, Excel, Word).
  • Project Management skills
  • Drafting and authoring regulatory document experience is a plus
 
This is not a comprehensive job description.
 
Click “APPLY” to send your resume for this role or you can send an email to me at Vibhash.shukla@artech.com. You can also reach me directly at 973.967.3546
 
Artech has been an employer-of-choice for 27 years, proudly serving over 80 Fortune 500 companies.  We have dedicated professionals that will help you with your next career move.  Our recruiters will listen carefully to your career goals and then match your skills and aspirations to various open roles.  There is nothing we are more passionate about than finding candidates a rewarding job that makes them happy.  Artech is an EEO Employer.