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Associate Director, Process Development

Nitto Denko Technical Corporation

Location:
Oceanside, CA
Posted Date:
7/2/2014
Position Type:
Full time
Job Code:
1004
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biochemistry, Biomedical, Biotechnology, Cancer, Chemical Engineering, Chemistry, Clinical Research, CMC, Drug Discovery, Oncology, Pharmaceutical, Process Development, Scientist Molecular Biology,

Job Description

NITTO DENKO TECHNICAL CORPORATION (NDT, www.ndtcorp.com) is a company Creating New Technologies for the Business Centers of Tomorrow. Founded in 2000, NDT now has two research divisions with over 100 scientists and researchers: Advanced Technology Center and the Biomedical division, both focus on cutting edge technologies that will provide practical solutions for leading industry sectors such as Pharmaceuticals, Biotechnology, Optronics, Nanotechnology, and others into the next decade and beyond. Our long-term vision and unparalleled, multi-disciplinary team of researchers from all over the globe make NDT a vibrant and exciting center of new ideas and brilliant technologies.

Now NDT has one immediate opening for a highly motivated and creative scientist to join our location in Oceanside, CA.




Successful candidates will have an M.S. or Ph.D. degree in biomedical or chemical engineering, pharmaceutics or closely related field, with a minimum of 7-9 years relevant pharmaceutical manufacturing and process development experience, with an emphasis on sterile injectable products. The successful incumbent will direct the design and scale-up of liposome manufacturing processes, select appropriate instruments and equipment from the laboratory through pilot plant and manufacturing scale-up. Incumbent will manage the outsourcing and oversight of Contract Manufacturing Organizations (CMOs) to produce bulk product including drug substance (API), novel excipients, and drug product. Knowledge of Quality Target Product Profile, Critical Quality Attributes, and Critical Process Parameters as well as a working familiarity with Quality by Design (QbD) is essential. Additional responsibilities include coordinating the activities between various global sites and supply chain needs to ensure timely delivery of clinical trial materials meeting all release specifications and global regulations.

Manage the development, implementation and maintenance of process methods and equipment for the production of process formulas, technologies and products to achieve cost effectiveness and improved product quality.  Plans and implements the development of new process formulas, establishes operating equipment specifications and may improve manufacturing techniques and new process equipment production.  Acts as liaison with research and/or development to ensure processes and designs are compatible.  Selects, develops and evaluates personnel to ensure the efficient operation of the function. Works on problems of moderate scope in which analysis of situation or data requires review of identifiable factors.

Requirements

Required:
•   Post graduate academic qualifications (M.S. or Ph.D. preferred) in chemistry, bioengineering, chemical engineering or a closely related discipline.
•   Process development, manufacturing, and scale up of sterile injectable products in a GMP regulated environment.
•   Pilot or production scale manufacture and process development of liposomes.
•   Expert knowledge of aseptic processing techniques.
•   Extensive product development experience (8+ years) with drug delivery systems, biophysical, and molecular biology techniques as they pertain to product characterization and release assays.
•   Expert-level knowledge of liposome drug delivery systems, including their manufacture demonstrated by sustained performance and relevant accomplishments requiring technical proficiency, scientific creativity, collaboration with others and independent thought.
Desired:
•   Familiarity and implementation of key elements of quality by design.
•   Strong project management experience, including setting and meeting project milestones.
•   Authoring IND CMC sections.
•   Experience leading a team of Scientists to achieve goals in a pre-clinical setting.
•   Experience with all stages of  product development, including pre-clinical and clinical research, and process development for GMP manufacturing controls.
Essential Functions:
•   Direct the design and scale-up of liposome manufacturing processes, select appropriate instruments and equipment from the laboratory through pilot plant and manufacturing scale-up.
•   Engages in technical transfer of formulations from the lab to the process arena to ensure successful full-scale manufacture of clinical and commercial liposomal siRNA formulations.
•   Exercises independent judgment in developing methods, techniques and release criteria to ensure the successful release of clinical materials.
•   Oversees and manages the activities of the research group that will investigate alternative technical processes for future large-scale manufacture of the liposome siRNA carrier.
•   Acts independently to determine methods, procedures, and alternative technical processes for the production and formulation of the liposome siRNA carrier.
•   Prepares technical reports and makes recommendations to senior management based on research outcomes.
Non-Essential Functions:
•   May represent Nitto Denko Technical in the scientific community by sharing research findings in writing scientific articles or presenting at scientific conferences.
Work Context:
•   This position splits its time between an office and laboratory environment. Lab work may include the use of centrifuges, microscopes, spectrometers and other laboratory tools.  Will be required to wear personal protective equipment and comply with all safety regulations in the lab.  
•   Software used will include most typical office applications such as word processing and spreadsheets, and may include project management and analytical or scientific technology.
•   Works in a team environment, regularly interacting with others in writing, by phone, email, and in person.  
•   This is a professional full time position that may require more than 40 hours per week to achieve project objectives, and may require moderate travel (approx. 6-12 trips per year).

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