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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 careers@coriumintl.com

R&D Quality Assurance Manager
Menlo Park, CA

Major Responsibilities

This position is primarily responsible for Quality Assurance activities to support R&D development projects - including clinical and preclinical studies. This position will mainly be focused in supporting cGMP activities and projects and may occasionally support GLP (non-clinical) related projects. The incumbent will work with the key stakeholders to assure GLP studies and cGMP activities are performed in accordance with current regulatory guidelines and company procedures.

  • As a QA Subject Matter Expert (SME) provides support for project teams and act as a QA contact point to review quality related issues and facilitate problem solving and corrective action.
  • Review and approve SOPs, validation/stability protocols and reports, labeling and packaging records, specifications and Batch Production Records and certificate of analysis to support clinical product release.
  • Support review and approve deviation investigation (initiation and reports), change controls, and CAPA for R&D projects.
  • Review and approve Batch Production Records, SOPs, validation/stability protocols and reports, labeling and packaging records, and specifications.
  • Author new procedures, and perform periodic review, and revise as needed, of existing procedures to ensure compliance with current regulatory requirements.
  • Perform internal and/or external audits to assess compliance and support external laboratory qualification, as needed.
  • Maintain cGMP quality metrics, to include in corporate QA quality trend reports.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Support stability programs, which includes but not limited to review/approval of study protocols, reports, support preparation of APRs, track stability studies, trend stability data for all clinical phases.
  • Ensure materials that are manufactured at contract sites comply with cGMP and/or regulatory guidelines.
  • Act as a quality role model by following regulatory guidelines and company policies.
  • Be conscious about safety of self and others by maintaining safe work environment.
  • Manage quality agreements with external GLP testing laboratories.
  • Compile and organize executed GMP record documentation, which includes, but is not limited to, protocol deviations, report, analytical data package, together with associated documentation.
  • Update and maintain Quality Assurance logs and databases, and generate metrics as needed.
  • Provide regular training to R&D personnel and monitor training records.
  • Supervise other quality professionals with the department as needed.
  • Perform other duties as assigned.

Position Requirements

  • Bachelor's Degree (BA/BS), preferably life science with 8+ years' experience in GLP study activities and in GMP Quality Assurance that support pharmaceutical product development and lot release.
  • Must have working knowledge of cGMP (21 CFR parts 210, 211, 820) and GLP (21CFR58) regulations.
  • Auditing Certification and or equivalent experience is desirable.
  • Experience working with contract laboratories is desirable.
  • Previous supervisory experience is desirable.
  • Must possess excellent verbal and written communication and presentation skills.
  • Must have proven ability to identify quality issues/discrepancies, and ability to effectively and pro-actively bring them to resolution.
  • Must have excellent time management skills, effective in multi-tasking, have excellent orientation to detail, problem solving, and decision making to manage assigned projects/tasks effectively.
  • The ideal candidate is goal-oriented, self-motivated, and collaborative; is able to work independently as well as in a team environment including cross-functional teams.
  • Excellent knowledge and understanding of Microsoft office suite - Word, Excel, PowerPoint, and Visio.
  • The incumbent in this position must be able to remain in a stationary position more than 50% of the time operating a computer.
  • Occasional travel required.

Please e-mail your resume to careers@coriumintl.com

Senior Corporate Paralegal
Menlo Park, CA

Major Responsibilities

The Senior Corporate Paralegal will report to the Vice President of Corporate Development and will provide legal assistance and contract administration for the entire organization.

  • Prepare and coordinate documentation for general legal matters, including public company SEC and securities compliance.
  • Direct equity administration, including managing third party equity service and transfer agent.
  • Direct corporate governance, including preparation for board of directors and annual stockholders meetings.
  • Responsible for tracking legal and financial obligations and fees.
  • Coordinate communication from and act as a liaison between internal personnel, legal department, and external contacts including outside counsel.
  • Prepare and manage a wide variety of agreements, including clinical trial agreements, CDAs, consulting agreements, material transfer agreements, NDAs, master service agreements, and vendor agreements.
  • Implement and manage a contract management database incorporating systems for tracking and monitoring the status of contracts and their key provisions, and implement improvements to the contract management process as necessary.
  • Review contracts and agreements and coordinate with company personnel to ensure adherence to company policies, legal, and contractual requirements.
  • Maintain tracking system to comply with trademark regulations.
  • Government Agency Compliance
  • Patent coordination activities including maintaining patent files

Position Requirements

  • BA/BS is required, and paralegal certification is preferred (notary public a plus)
  • 7+ years relevant corporate paralegal experience. Experience in the biotechnology/pharmaceutical industry a plus
  • 4+ years in-house experience
  • Familiarity with industry standard terms a plus
  • Extensive SEC and public company reporting experience
  • Ability to coordinate multiple projects across departments and with outside counsel
  • Excellent written and verbal communication skills
  • Ability to comprehend and manage business and legal contracts and documents
  • Strong organizational and planning skills and excellent attention to detail
  • Able to work independently while exercising initiative, flexibility and good judgment
  • Intellectual property background and experience a plus
  • Strong team player who is customer service oriented
  • Computer proficiency in Word, Excel, Outlook and PowerPoint
  • Some experience with contract management programs
  • Outstanding management skills and interpersonal skills, and the ability to work with all levels within the organization in a positive, collaborative manner

Please e-mail your resume to careers@coriumintl.com

 

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