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ARx Pharmaceutical Formulator

Adhesives Research, Inc. • Glen Rock, PA
a month ago

Job Summary:

Responsible for the design and development of new products, creation of new technologies, and improvements to existing products

 

Essential Functions:

  • Defines project design & strategy consistent with application requirements; reviews and shares with project team members and others in the organization as appropriate.
  • Develops formulations and related product constructions including selection of raw materials, experimental evaluations (e.g. compatibility, stability, performance, etc.) and specifications; frequently works on more than one project at a time with number depending on scope and timing.
  • Designs & conducts experiments on lab and production scale; draws valid conclusions upon analysis of technical data from experimental testing, expertise, and literature references. 
  • Defines test methodologies and requirements; prepares test samples and conducts tests on raw materials, in-process intermediates, and/or finished products as required to support programs; develops new tests as necessary to support development or product improvement projects.
  • Fulfills responsibilities in an efficient and effective manner; makes critical distinctions in support of prioritizing and organizing work; anticipates and proactively addresses potential lab development, scale-up, validation, clinical, regulatory and commercial issues during development.
  • Efficiently troubleshoots and solves technical problems. 
  • Participates in the design and specification of production-scale processes and validation thereof.
  • Contributes and represents R&D while serving on cross-functional teams chartered to develop and commercialize new drug delivery products; interacts effectively fulfilling functional responsibilities, collaborating with functional counterparts & customers to assure overall project success. 
  • Researches literature and patents as needed to effectively assure freedom-to-operate and otherwise support projects.
  • Maintains up-to-date, well-organized, clear and accurate information in lab notebooks and design records consistent with established company & divisional practices.
  • Supports and contributes to maintaining office and laboratory environment consistent with LEAN 6S and all regulatory requirements.
  • Interacts with customers as needed to support projects; behaves in a respectful and professional manner and able to earn & maintain the confidence of associates and customers.
  • Recognizes opportunities for and participates in patenting technology yielding sustainable competitive advantage.
  • Maintains a current awareness of pharmaceutical and drug delivery technologies to build expertise and applies same to benefit business.
  • Ensures up-to-date compliance with all training requirements; understands overall business strategy and plans while also working to execute responsibilities in accordance thereof.
  • Makes identifiable and beneficial contributions to continuous improvement; performs all duties safely and consistent with established company and divisional procedures and guidelines; actively complies with and endorses department, divisional and company objectives. 
  • Responsible for following all applicable waste handling procedures.

 

 

Additional Responsibilities:

  • Benchmarks equipment and systems.
  • Performs other related duties as assigned.

 

Job Specifications:

  • B.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or Polymer/Materials Science with a minimum of 2 years experience in pharmaceutical and/or drug delivery systems formulation; advanced degree and/or more extensive experience may be preferred.
  • Polymer formulation and mixing process experience in drug delivery required with coatings experience preferred; transdermal and/or oral solid dosage form experience preferred; proven track record of successful commercial outcomes desired.
  • Knowledge of and experience with cGMP, 21CFR Part 211 required; QbD, PAT, ICH & ISO experience additive.
  • Must communicate fluently in English and have excellent communication and interpersonal skills.
  • Capable of performing duties independently with limited supervisory direction.
  • Ability to effectively manage multiple priorities.
  • Familiarity and aptitude with chemical analytical techniques and associated data analysis.
  • Working knowledge of statistically-based experimental techniques.
  • Ability to maintain confidentiality.
  • Ability to conduct self in a professional manner & maintain appearance accordingly.
  • Functioning capability with standard computer software (word-processing, spreadsheets, internet & database searching, email, etc.) and Oracle ERP systems.
  • Grade Level is determined by achievement of respective elements within the Technical Progression Criteria.