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Jobs at Ascendia Pharmaceuticals

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Analytical Chemist in Pharmaceutical R&D

  • Ascendia Pharmaceuticals

    • On-site
    • North Brunswick, NJ

Scientist/Senior Scientist in Pharmaceutical Formulation R&D

  • Ascendia Pharmaceuticals

    • On-site
    • North Brunswick, NJ

1–2 of 2 jobs

Analytical Chemist in Pharmaceutical R&D

  • Ascendia Pharmaceuticals

  • North Brunswick, NJ 08902
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On-site

Not Disclosed

Bio-Pharma

R&D

  • Posted on:

Job Description

Summary

Ascendia Pharmaceutical Solutions is looking for formulation scientists for its Pharmaceutical R&D. This position will conduct activities related to formulation development under research and development settings. The successful candidate will be actively involved in developing formulation and manufacturing process and transferring these methods and processes to drug product manufacturers. The ability to work effectively in a collaborative, interdepartmental team environment is essential to this role with the expectation that this scientist will interact with all disciplines of drug development, including discovery, pre-clinical, clinical, preformulation, analytical R&D, and regulatory. A thorough understanding of pharmaceutical development process from discovery to commercialization is highly desirable.


Responsibilities
  • Design formulations and process for complex and challenging compounds.
  • Actively involved in project management and product development strategies. Handle all technical, legal, and regulatory aspects of development projects.
  • Participate in discovery and clinical development project team to inform and update the team on the status of all active projects
  • Write and review CMC reports and documentation for regulatory filings.
  • Keep current with regulatory guidelines, technical innovations, and new developments within pharmaceutical industry.


Qualifications
  • The position requires a M.S. or Ph.D. degree in Pharmaceutics, Physical Pharmacy, Chemical Engineering, or Pharmaceutical sciences with relevant pharmaceutical experience. A candidate with a Bachelor degree in a relevant field and extensive industrial experience will be also considered.
  • Industrial or academic experience in solid oral or parenteral dosage form development, process optimization and scale-up.
  • Experience in Innovative approaches to solving formulations challenges and formulation technologies to improve solubility and bioavailability of poorly water soluble drug ispreferred.
  • In-depth understanding of preformulation, formulation, biopharmaceutics principles required to get a drug from discovery through clinical development is desirable.
  • Strong scientific expertise, demonstrated by published scientific articles in peer-reviewed journals, society participation, regulatory filings and patents. Proficient in using computer to write and review technical reports and scientific judgment in data evaluation.
  • Excellent communication skills, problem solving, critical thinking, and organization skills. Ability to work in a fast-paced organization with diverse project teams and personnel.
  • Knowledge in pharmaceutical product development, CMC regulatory requirements, project management; and capability to collaborate with colleagues.
  • EEO/AA M/F/V/D


Education

Degree

Masters/PhD

Specialization

Pharmaceutics/Physical Pharmacy/Chemical Engineering/or Pharmaceutical sciences
Experience:

5-10 yrs

  • Skills:
  • Solid oral dosage forms
  • Parenteral Formulation,
  • Process Optimization
  • Scale-Up, Solubility Enhancement
  • CMC Regulatory Requirements
  • Scientific Data Analysis
  • Job Type:
  • Full-time
  • Shift Type:
  • Day shift
  • Monday to Friday
  • 8 hour shift

Compensation

  • Benefits:
  • 401K
  • 401K Match
  • Medical, Dental, Vision
  • Additional:
  • Base Salary

Job ID:

CGXP_26_31061

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