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Generic Pharmaceutical Manufacturing - Formulations and Technical Services

Company: Chartwell Pharmaceuticals
Location: Congers
Posted on: November 25, 2022

Job Description:

Chartwell Pharmaceuticals, LLC is a privately-held, US-based generic pharmaceutical manufacturer with manufacturing sites in Congers (Rockland County) and Carmel (Putnam County), New York, and R&D Operations in Israel. With nearly 500 ANDA listings in the FDA Orange Book, Chartwell is rapidly growing and transforming our business as a full-scale Generic Pharmaceutical Manufacturer and Distributor serving the Retail, State and Federal Government Markets under the "Chartwell Rx" labels. This is an excellent opportunity to get in on the ground-floor with a fast-growing and dynamic generic pharmaceutical company!
Position HighlightsProvide scientific, technical and hands-on support of Formulations and Technical Transfers of previously approved dosage forms into the Chartwell Pharmaceuticals sites, or to 3rd party sites. Must have a current understanding of formulation development, QbD, and tech transfer process from kick-off through validation. Possess strong technical skills in pharmaceutical manufacturing, scale up and scale down processes and packaging, relevant process equipment, formulations, API characterization, pre formulation and excipients performance. Should have knowledge of analytical methods. High sensitivity to QA, RA, QC requirements for regulatory filings. Identify opportunities to improve the process or materials to achieve best cost and efficiency.
Specific Responsibilities and Assignments

  • Work independently to design, conduct benchtop formulation experiments.
  • Evaluate and document key ANDA/NDA approval details.
  • Responsible for execution of lab scale, scale up and validation batches.
  • Perform gap analysis and characterize the changes required for formulations.
  • Record experiments in laboratory notebooks.
  • Compile data, data presentations, prepare product development reports and author technical reports for submission/validation batches.
  • Perform scale-up studies and prepare technical transfer report for cGMP manufacturing.
  • Ability to operate small scale up manufacturing equipment.
  • Identify problems, troubleshoot and offer solutions to advance assigned projects.
  • Work with operations team to ensure equipment and capacity readiness for all required work.
  • Provide clear and accurate verbal and written reporting of technical activities.
  • Provide product status, with relevant materials for decision support.
  • Perform maintain Research and Development lab equipment/instruments.
  • Should meet project timelines and performance standards as assigned.
  • Carries out responsibilities in accordance with organizational policies and procedures.
  • Perform other duties as assigned.
  • Be challenge driven, willing to take on extra responsibility to achieve organizational goals. Essential Skills
    • Bachelor or Master's degree in a related scientific discipline desired.
    • Minimum 2 years of Pharmaceutical formulation and process development, technology transfer and scale up experience supporting technical and operational activities in liquid dosage forms.
    • Experience and working in cGMP environment and knowledge in regulatory guidance.
    • Superior problem solving, organizational and analytical skills, highest attention to detail, and ability to proactively seek multiple internal and external data sources and insights and synthesize into meaningful observations and action plans.
    • Superior communication skills (verbal, written and presentation).
    • Highly ethical and transparent, with professional sensitivity and care for confidentiality.
    • Must have proficient computer skills. PLEASE NOTE:
      • This position is based in Congers, NY and we only seek candidates from the New York Metropolitan area.
      • Candidates must meet all of the criteria in the qualification questions.
      • Sponsorship is not available for this position.
      • Agency referrals are not accepted.

Keywords: Chartwell Pharmaceuticals, Yonkers , Generic Pharmaceutical Manufacturing - Formulations and Technical Services, IT / Software / Systems , Congers, New York

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