Corium - Jobs

JOBS

	Quality Scientist Grand Rapids, MI Major responsibilities The Quality Scientist will be responsible for evaluating drug, medical device, cosmetic products and raw materials using HPLC, GC, Dissolution, UV-Vis, FTIR, and other chemical testing methods and equipment. Reviewing laboratory data and completing OOS investigations. Creating written procedures, methods, and instructions for laboratory activities and maintaining compliance to FDA, DEA, ISO, and customer requirements. Performing and completing analytical test method validation and transfer protocols as well as equipment validations and qualifications with appropriate assistance. Maintaining, operating, troubleshooting, and calibrating laboratory equipment. This position will also be expected to communicate quality information appropriately, accurately, and in a timely fashion. Position Requires The successful candidate will have a minimum of a Bachelors degree in chemistry or other science discipline and 8 years of demonstrated QC laboratory experience in the pharmaceutical or medical device industry. Corium International, Inc. offers an excellent compensation package and benefits. Please e-mail your resume to jobs@coriumintl.com.
	Quality Analyst Grand Rapids, MI Major responsibilities The Quality Analyst will be responsible for evaluating drug, medical device, and cosmetic products and raw materials using HPLC, GC dissolution, UV-Vis, FITR, and other chemical and microbiological equipment and methods. This position will also perform and complete analytical test method validation and transfer protocols as well as equipment validations and qualifications with appropriate assistance. The position will maintain, operate, troubleshoot, and calibrate laboratory equipment as well as communicate quality information appropriately, accurately, and in a timely fashion. Position Requires The successful candidate will have comprehensive knowledge of FDA, cGMP, ISO, and quality assurance principles and well as experience in quality reporting, trending, and data analysis. Must have at least a 2 year degree in a science discipline and/or 2-5 years of QA laboratory experience in the pharmaceutical or medical device industry. Corium International, Inc. offers an excellent compensation package and benefits. Please e-mail your resume to jobs@coriumintl.com.
	Senior Scientist Grand Rapids, MI Major responsibilities The Senior Scientist will have significant responsibility in managing the analytical activities of multiple projects. This includes performing laboratory analysis, interaction with customers and actively participating on the project team. Advanced technical ability in developing HPLC and GC methods for analysis of impurities in complex matrices is required. The candidate must be very knowledgeable in cGMP and regulatory requirements. The position will include writing transfer and validation protocols and reports. The candidate must have demonstrated ability to train and mentor colleagues in laboratory and research and development activities. Some supervisory experience is desired, as well as the potential for eventually moving into a supervisory role. Position Requires The successful candidate will have a minimum of a Bachelors degree in a science discipline and 15 years of demonstrated laboratory experience in analytical R&D in the pharmaceutical industry; Masters degree in a science discipline and 10 years demonstrated experience; or a PhD in a science discipline and 5 years demonstrated experience in the pharmaceutical industry. Relies on experience and judgment to plan and accomplish goals. Performs a variety tasks. Works under minimal supervision and provides leadership and guidance to coworkers. A wide degree of creativity, latitude, and independent judgment is required. Corium International, Inc. offers an excellent compensation package and benefits. Please e-mail your resume to jobs@coriumintl.com.
	Project Manager - Chemical Engineer Grand Rapids, MI Major responsibilities Position is responsible for project management and manufacturing support incorporating consumer and medical product lines. Manufacturing technology includes mixing, drying, coating, die cutting, web press, assembly, and packaging applications. The individual selected will be accountable for project management and operational results within the two facilities. The position requires management of technology, teams, vendors, materials and engineering for the company’s major product lines. Due to the company’s addition of new customers and production lines, emphasis is on managing growth, implementing process improvement systems and supporting new product and process introduction. Position Requires BS ChE, minimum 3-5 years experience in process development, plant support and project management in the pharmaceutical industry. Strong pharma, medical device or other FDA-regulated industry experience preferred. Will consider related industry experience (e.g., emulsions, consumer products). Excellent communication skills required, plus ability to work with plant operators in troubleshooting, present to customers, support pilot plant and scale-up. Mechanical ability and experience a plus. Position reports to Manager of Process Development and Project Management and works closely w/ manufacturing and engineering. Job is located in Grand Rapids, MI. Excellent compensation package and benefits. Please e-mail your resume to jobs@coriumintl.com.
	Group Leader/Manager - Protein Formulations Menlo Park, CA Major responsibilities The successful candidate will lead pre-formulation and formulation development activities for protein, peptide and vaccine drug substances for incorporation into a novel polymeric microneedles drug delivery platform. They will lead the creation of the formulation development strategy for pre-clinical and clinical phases of these projects and generate the supporting development plans. They will direct, coordinate and participate in the work of the protein formulation team, as the organization’s technical protein/peptide expert. This person will lead the development of the formulations including the material and product specifications. They will investigate the compatibility of the active pharmaceutical ingredients and excipients. They will design and execute studies of drug product and platform stability under both accelerated and real time conditions. They will lead the development of characterization methods. This position will work closely with device engineering, and ultimately transfer technology to the process engineering group for scale-up in clinical and commercial production and provide ongoing support thereafter. This individual will also provide technical interface with FDA in pre and post IND meetings and assist with regulatory submissions by compiling and writing CMC sections. The position will also involve interaction with external clients and groups, vendors and CRO’s. Requirements A PhD in Biochemistry, Pharmaceutics, Chemistry or a related degree At least 5 years technical experience in the pharmaceutical or biopharmaceutical industries A successful track record developing formulations for parenteral administration of proteins, peptides or vaccines with experience formulating polymeric delivery systems a plus A thorough understanding of protein/peptide structure and properties with the aim of formulating and integrating these molecules in polymeric solid state microneedles Experience creating, documenting and implementing a formulation development strategy and associated studies to support pre-clinical and clinical development of products Direct practical experience & expertise of both excipient and process strategies for formulating proteins/peptides to ensure room temperature and sterilization stability; Techniques & equipment used to characterize proteins/peptides: Design of Experiments; Stability study design Leadership ability. Able to create win win solutions in a cross-functional environment to issues involving different scientific, engineering, analytical, regulatory or tactical approaches Well versed in safety and handling of recombinant complex proteins and hazardous agents including vaccines Preference will be given to candidates with direct experience in the following areas: A successful track record developing protein, peptide or vaccine solid state formulations from feasibility through clinical trials Novel materials or approaches for incorporation of drugs into medical device platforms QSR, cGCP, cGMP, ISO and quality assurance principles. CMC sections of IND applications and NDAs Please e-mail your resume to jobs@coriumintl.com.
	Manager - Transdermal Product Development Menlo Park, CA The candidate will be responsible for managing activities related to product development of generic and branded transdermal Rx products. The candidate will oversee material selection, formulation development, prototype development and characterization, and animal safety and pharmacokinetic studies leading to IND filing. The candidate will assess viability of material and design choices for scale-up and large scale commercial manufacturing. This person will support clinical development by working closely with process development and developing material/product specifications and test methods and associated documentation. The position will work closely with analytical development, process development and engineering, clinical and regulatory. This position will also interact with external groups, vendors and CROs. The candidate will provide technical interface with FDA in pre and post IND meetings for performing preclinical and clinical studies. The candidate is expected to be well versed in techniques and equipment used in transdermal drug delivery such as in vitro skin permeation, release rate testing and processes of mixing, coating, laminating and drying. The candidate will write feasibility and development reports and relevant portions of CMC sections of IND, ANDA and NDAs. This position will be expected to provide innovative and creative ideas in the development of next generation transdermal products. Requirements A PhD or M.S. in Pharmaceutics, Material Science, Chemical Engineering, Chemistry or a related degree is a must. A minimum of 5 years experience in the pharmaceutical industries developing and managing transdermal product development is required. Excellent written and verbal communication skills as well as excellent interpersonal skills are a must. Corium International, Inc. offers a competitive salary with comprehensive benefits package. This position is located at our Menlo Park, CA, facility. Qualified candidates who are local to the San Francisco Bay Area are invited to submit via email, a current resume with salary history to: jobs@coriumintl.com.
	Senior Scientist/Group Leader - Analytical Development Menlo Park, CA Major responsibilities Develop, qualify, and implement assays for peptide, protein and vaccine drug substances. Research and develop associated impurity and degradation profile methods. Develop analytical methods for characterization of peptides, proteins and vaccines in novel drug/device combination products. Develop analytical methodologies for testing functionality of drug delivery systems. Interface with external laboratories including contract laboratories, academic institutions, and pharmaceutical manufacturers. Implement and execute GLP and GMP procedures in support of regulatory submissions. Assist in technology transfer for clinical supply, scale-up and commercial production. Ensure compliance with current SOPs, safety and environmental regulations and cGMP. Support technical information database and knowledge management system development. Requirements Ph.D. in Analytical Chemistry, Chemistry, or Pharmaceutical science with a minimum of 5 years experience in the pharmaceutical or biopharmaceutical industries. Experience in the drug delivery industry is an advantage. A minimum of 5 years hands-on experience developing analytical methods for biopharmaceutical compounds such as protein, peptides and vaccines using HPLC, UV-VIS and ELISA, and other spectroscopic methods to include equipment calibration and method development, qualification and validation. Ability and willingness to learn new methods specifically related to drug delivery is mandatory. Must have excellent communications and interpersonal skills with ability to work in a global cross-functional environment. Must have demonstrated ability to multi-task in high activity environment. Experience in leading and motivating direct report team of scientists. Strong familiarity with FDA/ICH guidelines, cGMP Regulations and the preparation of the documentation to support CMC sections of regulatory filings. Experience in communications with regulatory authorities (FDA, etc.) Well versed in safety and handling of recombinant complex proteins and hazardous agents including vaccines Strong Excel, Word and Power Point skills. Please e-mail your resume to jobs@coriumintl.com.
	Senior Mechanical Engineer Menlo Park, CA We are seeking a hands-on, creative Senior Mechanical Engineer with proven design experience to join our team. Medical device experience a plus. Major responsibilities Device design including mechanisms and fixtures Work with R&D team for quick proof of principle prototypes Create and manage drawing files Setup and manage in-house machine shop Assist in document preparation for regulatory filing Requirements BS in Mechanical Engineering or related fields Excellent 3D CAD expertise Hands-on machine shop experience Mechanism design Strong analytical and troubleshooting experience Comfortable / Enjoy working in a fast paced, multidisciplinary environment Ability to take projects from concept to completion in short time-frames Excellent communication, presentation, and technical writing skills Please e-mail your resume to jobs@coriumintl.com.
	Associate Scientist 1 - Research and Development Menlo Park, CA Major responsibilities Working within the Research and Development group, the successful candidate will conduct time-critical proof of concept studies on drug/medical device combination products, with particular emphasis on microneedle-based microporation technology. Specifically, they will: Characterize prototype devices by both chemical and mechanical methods. Evaluate novel dosage forms in both an in vitro drug delivery model and small scale in vivo studies. Document experimental findings, analyze data and present to members of the project team, along with recommendations for further studies. Requirements A B.S. in Chemical Engineering, Bioengineering, Biomedical Engineering, Biochemistry, Chemistry or related degree. Entry level professional, 0 - 2 years experience in a Research and Development environment, preferably in the pharmaceutical, biopharmaceutical or medical device industries. Excellent interpersonal skills for effective participation in multidisciplinary project teams, with well developed oral and written communication skills. Proven computer skills and knowledge of basic statistical tools. Please e-mail your resume to jobs@coriumintl.com.
	Scientist and Associate Scientist Menlo Park, CA We have open positions at the scientist and associate scientist level. Please e-mail your resume to jobs@coriumintl.com.
	Product Research and Devlopment Scientist Menlo Park, CA Major responsibilities Perform feasibility research and product development across a diverse portfolio of technologies and products. Responsibilities include formulation screening, formulation development and characterization of dosage forms for application to skin or oral mucosa. Develop workable prototypes and perform testing to optimize drug delivery. Assess viability of material choices for scale-up and large scale commercial manufacturing. Functional Responsibilities Feasibility research and product development. Interface closely with analytical, process and QA groups. Interface with internal and external clients. Technical Skills and Knowledge The candidate should have 0-4 years experience in topical/transdermal or oral mucosal drug delivery with emphasis on understanding physico-chemical properties of drugs and materials and applying that knowledge to develop dosage forms (liquids, gels, films, patches, etc) for application to skin or oral mucosa. Be well versed in techniques and instruments used in transdermal or oral mucosal drug delivery such as in vitro skin/mucosal permeation testing, mixing, coating, laminating, physical and mechanical characterization of transdermal and oral mucosal dosage forms. The candidate should have knowledge and experience of analytical techniques such as HPLC and GC. Experience Required The candidate must have a solid background in formulation and material science related to transdermal and oral mucosal product development. Possess strong written and verbal communication skills. Project management skills will be a plus. Education Required B.S., M. S. or Ph. D. degree in Material Science, Pharmaceutics, Biopharmaceutics, Chemical Engineering or other related area. Please e-mail your resume to jobs@coriumintl.com.
	Laboratory Technician Menlo Park, CA Essential Functions Maintenance of laboratory glassware and glassware inventory Preparation of buffer solutions and media Cleaning of dissoltuion test stations Stocking of labs (consumables and water) Organization of laboratory areas, including bench tops and cabinets. General facility maintenance as needed Disposal of hazardous and non-hazardous solid and liquid laboratory waste Maintenance of consumables and chemical inventory (ordering, receiving and stocking) Purchase order verification Performance of monthly safety checks (showers, eyewashes, fire extinguishers) Monitoring of stability chambers Requirements Minimum of two years college education in the field of science and or biotechnology in pursuit of a Bachelors degree Timely completion of assigned tasks with minimal supervision. Must be able to communicate on assignments daily with supervisors and lab analysts Experience in handling and disposing of biohazard, hazardous, and non-hazardous materials is preferred GMP experience preferred Working knowledge of a PC, including MS Outlook, Word and Excel software This is a part-time to full-time entry-level position. Please e-mail your resume to jobs@coriumintl.com.


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