Scientist, Analytical Development

  • Waltham, MA, USA
  • Full-time

Company Description

Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two lead product candidates. The product candidates are INVELTYSTM(KPI-121 1%) for the treatment of inflammation and pain following ocular surgery, for which we have submitted a NDA, and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease, which is currently in Phase 3 clinical development.

 

Job Description

Scientist, Analytical Development

Kala Pharmaceuticals is seeking a Senior Scientist, Analytical Development for analytical development, characterization, and technical support for preclinical, clinical, and commercial products. Come join an experienced and highly motivated team!

Key Responsibilities for this role will include:

  • Technical expertise in analytical development for pharmaceuticals products, including chromatography (HPLC, GC), mass spectrometry, spectroscopy and common physical and chemical methods

  • Analytical support of internal formulation and medicinal chemistry programs, including characterization of drug product and drug substance candidates

  • Management and communication with analytical CROs to assist in method development and execution

  • Author and/or review key documents such as: comparability protocols, methods, reports and regulatory filings

Qualifications

Our ideal candidate will have:

  • Proven technical ability, skill with problem solving and investigation

  • Ph.D. in chemistry, biology, biochemistry or related field and 2+ years of experience or Masters’ degree and 4+ years’ experience.

  • Experience with pharmaceutical characterization methods including HPLC, mass spectrometry, particle size determination and other physical and chemical methods.

  • Experience working in pharmaceutical analytical development with an understanding of regulatory requirements for product quality

  • Experience in writing technical documents in support of product development and regulatory filings

  • Excellent communication skills

  • Ability to work in a small, dynamic team with high technical standards

Additional Information

All your information will be kept confidential according to EEO guidelines.