2018-09-24

Associate Director-Small Molecule Product Developm
Job Opportunity at Clinical Dynamix, Inc.

Posted on Sep 24

http://www.clinicaldynamix.com    561-732-4505

Location: Irvine, CA
Job Type: Full Time
Job ID: W4164557

Position Overview
 
Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus solid and liquid dosage forms including immediate and controlled/modified release systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.
Experience in the development and manufacture of solid and liquid dosage forms including immediate and controlled/modified release systems is required.  Experience working with manufacturing process scale-up and technology transfer is also needed. Have working experience with applying Quality by Design (QbD) concepts and statistical process design and analysis (JMP statistical software) for formulation and process development. Have a working knowledge of characterization techniques used to evaluate critical quality attributes of these dosage forms. Possess a comprehensive knowledge of raw material  properties and critical quality attributes that can impact performance and manufacturability of sterile dosage forms. Familiar in FDA, EMA, ICH regulatory CMC guidance, GMP requirements and working experience in regulatory submissions are also required.
 
Main Areas of Responsibilities
 
The essential components of this position include in-depth understanding of pharmaceutical development of dosage forms including a thorough understanding of pharmaceutical formulation principles, manufacturing process development and tech transfer, global CMC regulatory requirements. In addition, strong organizational skills to develop formulations intended for clinical trials and commercialization is also needed.
 
Requirements
  • Provide scientific and technical leadership for development of solid and liquid dosage forms. Applies the principles of quality by design (QbD) and statistical process design/analysis to formulation and manufacturing process development.
  • Demonstrate scientific excellence in solid and liquid dosage form formulation and process development through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
  • Experience working with CROs/CMOs that specialize in solid and liquid product development as well as managing outsourced development projects with key consideration to worldwide regulatory expectations.
  • Apply current CMC regulatory requirements and guidances to support global registration of new products.
  • Exhibit leadership skills that result in good performance and career development of junior staff. Possess excellent communication (oral and written) and interpersonal skills.
 
 
 
Preferred Skills/Qualification
  • Review internal and external technical documents, writes technical memos/reports, patents, scientific articles. Presents scientific/technical seminar annually at Pharmaceutical Development Seminar series.
  • Represents department at CMC/project team meetings and work closely with other Pharmaceutical Sciences departments, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development, CROs/CMOs and Marketing to meet project timelines and objectives.
  • Performs supervisory duties including reviewing progress of assignments against established project timelines, assistance on daily work direction, problem solving and advice to junior staff to enhance their work effectiveness in generating data, ensuring good record keeping of all laboratory data, adherence to lab safety and general staff development.
  • Proven track record in developing and manufacturing solid and liquid product formulations as evident with approved products, patent applications, etc.
 
Education
 
Ph.D. preferably in pharmaceutical sciences or chemical engineering with 8+ years of applicable experience or M.S with 12+ years of relevant experience. Knowledge of fundamental applications of statistics is preferred. *LI
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