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Working at Corium
Director/Senior Director of Product Development
Menlo Park, CA

Major Responsibilities

The Director of Product Development will lead the design and development of drug-device combination microneedle products, including device development, drug processing, novel materials and processes development, and manufacturing process/equipment development, from proof of concept through clinical and commercial production. The position mentors and coaches an engineering group that designs, tests, integrates, documents and validates new product concepts/equipment, and new designs.

  • Responsible for Product and Process Development of aseptically manufactured Microneedle based drug delivery products
  • Provides senior leadership to Product Development engineers and contract manufacturers to develop and implement prototypes, prototype tooling, prototype and pilot manufacturing process, testing equipment, and testing/manufacturing procedures.
  • Lead teams in solving design or process problems (Champion six sigma and lean method development in the organization; facilitates problem solving techniques to overcome complex technical problems and provide solutions which are highly innovative
  • Develop models/systems to integrate and manage complex multi-discipline projects over the product life cycle
  • Responsible for leading technology transfer teams to pilot and/or commercial scale manufacturing
  • Interacts with internal and external management and customer representatives concerning projects, scheduling requirements and/or contractual clarifications.
  • Leads briefings and technical meetings for internal and external representatives.
  • Provide operational planning and budget development and management.
  • Supplier & consultant contract negotiation and vendor management.
  • Leads and manages the support for Operations group in failure investigation and product enhancement on existing products.
  • Create design control and CMC portions of regulatory submissions.

Position Requirements

  • BS/MS/PhD in Mechanical Engineering or other related engineering discipline, with 15+ years of medical device and or combination product development experience in pharmaceutical/medical device industry; 10+ years experience in leadership role.
  • Successful experience with development and scale-up of medical devices and/or combination products from POC stage through commercialization
  • Comprehensive product development design, design for manufacturability, industrial design, human factors, FMEA, and design control experience
  • Extensive experience in cGMP's and aseptic processing
  • Demonstrated proficiency with stage gate design control for device development and QbD for process development
  • Experienced in leading large scale projects and programs and direct supervision of advanced level engineers.
  • Experienced in regulatory requirements/submissions of drug-device combination products including design controls; familiar with CMC's requirements/submissions for the drug product
  • Experienced user of PC based design tools (design simulation, CAD - e.g. SolidWorks, AutoCAD, Mechanical Desktop).
  • Knowledge of cost effective design techniques.
  • Support of manufacturing to resolve production problems.
  • Excellent communication skills, both written and verbal. Ability to prepare technical reports and presentations to senior level management
  • Creation of schedules and budgets and tracking of tasks/budgets

Please e-mail your resume to menloparkjobs@coriumtech.com

Engineering Technician/Technologist
Menlo Park, CA

Major Responsibilities

To support the development of MicroCor Inspection processes and other engineering activities.

  • Assist with operation of specialized light microscope system.
  • Carry out various protocols for microsocpic imaging of microscale devices, including use of novel sample illumination and imaging strategies.
  • Assist with some development of these strategies and protocols for microscopic imaging.
  • Handle, prepare, and manipulate microscale devices to permit microscopic imaging and characterization of critical microscale features.
  • Perform mechanical assembly of various devices and fixtures in preparation for microscopic imaging.
  • Carefully observe and identify salient features and defects in microscale structures.
  • General "hands-on" laboratory work.
  • Assist with documentation of experimental results and procedures and observations.
  • Assist in writing standard operating procedures and work instructions.
  • Engineering drawings and sketches.
  • Create presentations in PowerPoint.
  • Communicate with vendors for technical support or to source parts.

Position Requirements

  • Background in engineering and design.
  • Experience with basic microscopy and/or optical inspection.
  • Knowledge of basic optics.
  • Demonstrate ability for "hands-on" work in a laboratory setting, especially handling and manipulating small parts and samples.
  • Knowledge of SolidWorks and/or AutoCAD and/or some kind of computer rendering software.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint).
  • Hands on experience with machine shop tools and prototyping desired.
  • Knowledge of GD&T convention and rules desired.
  • Proficiency in SolidWorks or equivalent desired.

Please e-mail your resume to menloparkjobs@coriumtech.com

Associate Scientist I-II
Menlo Park, CA

Major Responsibilities

The successful candidate will assist in skin flux lab to prepare the skin (human cadaver), maintain the skin inventory, initiate the skin flux experiment and quantification of samples by liquid chromatography (HPLC).

  • Prepare the skin (human cadaver) for in vitro skin flux experiments
  • Maintain the skin flux inventory
  • Start the skin flux experiments with prepared skin
  • Collect the samples and analysis by HPLC
  • Preparation of mobile phase and reagents
  • Glassware cleaning

Position Requirements

  • Experience in HPLC
  • Experience in handling of the human cadaver skin
  • Use of pH meter and routine lab equipments
  • Any formulation experience would be added value
  • BS in Science preferred
  • Experience in in vitro skin flux experiment set up
  • Experience in topical/transdermal/transmucosal drug delivery formulation. Documentation of work
  • Proficient in using MS Word, Excel and PowerPoint
  • Ability to communicate fluently in written and spoken English
  • Compliance with GMPs

Please e-mail your resume to menloparkjobs@coriumtech.com

 

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