Employment Opportunities

VP/Director, IND Program Management

LATITUDE is seeking a Vice President/Director of IND Program Management, to (1) file INDs to the FDA under the 505(b)(2) regulatory path for re-formulated drugs; (2) manage outsourced CRO/CMO activities to support IND filings, and (3) support CMC development of the re-formulated drugs. This is a salaried, full-time position, preferably based in our San Diego (CA) location, although remote location will be considered.

Job Requirements

  • Develop and plan regulatory CMC submission strategy, providing all the requirements for the submissions based on regulatory guidances, regulations and directives
  • Determine regulatory and scientific/technical requirements for CMC-related submissions
  • Determine budget(s) and timeline(s) for regulatory submission
  • Manage CRO/CMO activities (e.g., GLP Toxicology studies)
  • Proactively identify CMC issues for pharmaceutical development to ensure compliance with regulatory standards and scientific/technical requirements
  • Ensure timely preparation of CMC sections for regulatory applications, including Investigational New Drug applications (INDs)
  • Function as the company contact with regulatory authorities for CMC submissions

Required Skills and Experience

  • Ph.D. or M.S. in Chemistry, Pharmaceutical Sciences or Biochemistry
  • 10+ years’ experience in regulatory in the pharmaceutical industry required
  • Strong experience in preparing/reviewing regulatory sections for investigational product (IND) submissions, including timelines and budgets required
  • Experience with FDA guidances and IND filing requirements under the 505(b)(2) regulatory pathway required
  • Experience with injectable drug products preferred
  • Experience in managing CROs and CMOs for sterile product manufacturing preferred
  • Experience in small or specialty pharma company preferred
  • Strong CMC experience required
  • Formulation and analytical experience preferred
  • Strong written and verbal communication skills
  • Salary commensurate with experience

 

Formulation Scientist/Senior Scientist

LATITUDE is seeking a formulation scientist to lead individual drug formulation development projects. LATITUDE utilizes its extensive experience and proprietary technologies to solve issues of insolubility, instability, poor absorption and other formulation challenges over a range of dosage forms for both external clients and internal programs. A successful candidate will possess proficiency in a variety of analytical chemistry techniques. This is a salaried, full-time position at our San Diego location.

Job Requirements

  • Act as the lead on multiple projects with direct and/or indirect report management responsibilities.
  • Projects may involve pre-formulation assessment, formulation development, scale-up and/or tech transfer to manufacturing, as well as formulation optimization to provide desired solubility, stability and container compatibility.
  • Design, execute and interpret formulation development based on the defined deliverables, planning the activities to meet the project timelines. Oversee the progress of projects.
  • Prepare presentations of data and progress; make regular presentations to external clients during formulation development projects.
  • Maintain and ensure safe laboratory environment and work practices.
  • Remain current in the field by review of relevant scientific literature.
  • The candidate may be responsible for the supervision of a group of up to 2 direct reports.

Required Skills and Experience

  • Ph.D. or M.S. in Chemistry, Pharmaceutical Sciences or Biochemistry
  • 4+ years’ experience in a laboratory setting with analytical chemistry technique
  • Excellent verbal and written communication skills
  • Excellent computer proficiency (MS Office – Word, Excel and Outlook)
  • Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
  • Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices
  • Salary commensurate with experience

 

Research Associate

LATITUDE is seeking a Research Associate to carry out individual drug formulation development projects for our clients. LATITUDE utilizes its extensive experience and proprietary technologies to solve issues of insolubility, instability, poor absorption and other formulation challenges over a range of dosage forms for both external clients and internal programs. A successful candidate will possess proficiency in a variety of analytical chemistry techniques including HPLC. This is a salaried, full-time position at our San Diego location.

Job Requirements

 The position of Research Associate will report to a Formulation Scientist.

  • Assist the supervising Formulation Scientist to complete individual formulation development projects
  • Assist in the design, execution and interpretation of formulation development based on the defined deliverables, as well as in the planning of activities to meet the project timelines
  • Prepare presentations of data and progress and assist in regular presentations to external clients during formulation development projects
  • Perform related duties as assigned by supervisor
  • Maintain and ensure safe laboratory environment and work practices
  • Maintain compliance with all company policies (employee- or laboratory-based) and procedures

Required Skills and Experience

  • B.S. in Chemistry, Pharmaceutical Sciences or Biochemistry strongly preferred
  • 1-5 years’ experience in a laboratory setting (pharmaceutical, biotech or academic) with analytical chemistry techniques
  • Excellent verbal and written communication skills
  • Excellent computer proficiency (MS Office – Word, Excel and Outlook)
  • Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
  • Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practicesSalary commensurate with experience.

 

Interested candidates for these positions should send their resume (cover letter optional) to: jobs@latitudepharma.com.

LATITUDE Pharmaceuticals, Inc. is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  All applicants must have authorization to work in the U.S.

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