Director of Product Development

Job Summary:

Build-out and lead formulation and product development efforts within the R&D group, with an initial focus on sublingual//buccal films and transdermal patch dosage forms. The successful candidate will report directly to the Director of R&D North America.

Duties/Responsibilities:

• Responsible for all formulation development activities from pre-formulation, through formulation and
  product development, to transfer of the product to manufacturing.
• Primary contributor on one or more development programs of novel and generic products.
• Collaborate with, and assists, Business Development team with the review and scope of new
  business opportunities.
• Establish methodologies, tools and know-how required for successful formulation/product
  development: procuring/installing new equipment, hiring/mentoring personnel, collaborating with
  outside service vendors, etc.
• Work closely with clients to understand product requirements and communicate progress.
• Collaborate with the R&D Analytical team to develop test methods and characterize
  formulations/products.
• Perform new formulation/ product characterization studies such as, excipient
  compatibility, forced degradation, solubility screening, and others.
• Collaborate with the R&D Process Development team from process development stage to transfer the
  formulation/product to manufacturing.
• Write clear and comprehensive formulation development reports to support regulatory submissions
  (IND Applications, CMC Sections and other documents required to support IND Applications).
• Collaborate with internal and external team members on preparation of documentation packages intended for raw materials, in-process materials, and the finished dosage form suitable for product filings with FDA.
• Train new members of LTS’ product development (formulation) team; coach and guide less
  experienced Scientists. Technical mentor on equipment (HPLC, GC, Physical Tester, Franz Cell)
  needed to complete testing.

Education and Experience:

• Masters or Doctorate level education in a Scientific or Engineering field, with 3–10 years’ experience in
  formulation/product development is highly preferred.
• Expertise in sublingual/buccal and/or transdermal patches is preferred.
• Demonstrated ability to troubleshoot formulation/drug product issues.
• Experience developing and using analytical methods for product testing, such as HPLC, dissolution,
  disintegration, etc.
• Knowledge of CMC-related regulatory requirements and cGMPs.
• Superior technical writing skills.
• Strong organizational to handle multiple competing priorities in a fast-paced environment and
  complete required activities in a timely manner.
• Strong communication skills for effective collaboration with other company functions and clients.

Preferred Skills/Abilities:

• 7+ years experience in the FDA drug/pharmaceutical industry. Working knowledge of Food and Drug
  Administration (FDA), Occupational Health and Safety Administration (OSHA), Drug Enforcement
  Agency (DEA), cGMPs and GLPs regulations and guidances.
• Demonstrated in-depth scientific knowledge and experience in analytical method development, and
  validation.
• Experience in the development of pharmaceutical dosage forms and polymeric drug delivery systems
  with emphasis in transdermal delivery systems and thin oral films.
• Experience in statistical data analysis and QbD principles.
• Advanced understanding of polymer science, analytical development, drug and formulation
  characterization, optimization and scale-up.

Department/Division: Research and Development
Reports to: Director, R&D