Director/Senior Director of Product Development
Menlo Park, CA
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.
- 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 email@example.com
R&D Quality Assurance Manager
Menlo Park, CA
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.
- 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 firstname.lastname@example.org