Principal Engineer, Drug Polymer Formulation

Job Description
Job Description
Intersect ENT Inc., located in Menlo Park, Calif., is a public drug-device company focused on advancing clinically proven therapy solutions that improve quality of life for patients with ear, nose and throat conditions. The company’s initial products, the PROPEL and PROPEL mini dissolvable steroid-releasing implants, are the only products backed by Level 1-A clinical evidence to improve sinus surgery outcomes for patients suffering from chronic sinusitis. Chronic sinusitis is a common condition that affects one out of seven adults in the U.S. and greatly impacts quality of life. The company holds twenty-three issued U.S. patents and more than 80 patents and pending applications worldwide.

We are looking for an experienced drug formulation professional to handle the planning, management and/or support of implant and drug material, drug formulation selection, drug dosage development and selection, material processing development and drug/tissue interaction in the development of new drug and medical device products in support of company’s strategic plan. Define drug formulation material and drug dosing requirements along with material specifications, plan and execute material selection, material testing, material process development and material and formulation specification setting. Act as Technical Lead to the Team in support of drug, drug formulation, drug dosage, drug/tissue interaction related documents and questions supporting regulatory filings and other technical documents.

MAJOR DUTIES AND RESPONSIBILITIES:
• Apply drug, drug formulation, and materials knowledge to assist company in the development of new products and enhancements to existing products.
• Apply pharmaceutical and/or medical device industry knowledge to assist company in the development of new products and enhancements to existing products.
• Apply drug (corticosteroid) knowledge to assist company in the selection of drug formulations and drug dose in the development of new products and enhancements to existing products.
• Responsible for all aspects of formulation selection and drug/tissue interactions including the development of drug formulations/excipients, selection of drug dosing, pre-clinical formulation test development, in vitro test selection, selection of appropriate animal models, selection and development of pre-clinical testing measures, preclinical pharmacokinetics and modeling, and in vitro and animal model success criteria.
• Responsible for all aspects of material, drug and drug product selection and development including: new formulations, material selection, polymer and process development, drug and material testing and material specification setting, and product improvements.
• Responsible for drug and polymer interactions: formulation selection, processing, development, testing and specification setting.
• Apply knowledge about the structure of bioabsorbable materials and drug entities and knowledge of the impact of processing and environmental conditions on the polymer structure and properties to select appropriate materials for new product development and to develop appropriate processing conditions.
• Develop understanding and characterization of effect of drug physicochemical and solid state properties on drug formulation and product performance.
• Develops and/or supports in vitro and in vivo dissolution test methods to establish in vitro to in vivo correlation.
• Provide technical support of Regulatory Filings (CMC section of Device PMA, support for IND). Generate CMC documentation as needed to support Regulatory Filings.
• Ensure that all regulatory and internal policies are followed.
• Solid knowledge and background in implantable medical device design.
• Apply knowledge for thorough understanding of drug and tissue physiology and mechanism of action.
• Possess experience in the development and selection of corticosteroids including formulations and dosages.
• Develop and document new material, product and process IP. Support IP generation and work on rapidly growing and strengthening company’s IP position.
• Generate written protocols and reports that meet company and regulatory agency requirements.
• Oversee outside vendors and consultants as required.
• Work with other Research and Development, Engineering, Manufacturing, Quality, Clinical affairs, Regulatory, and Marketing staff to coordinate material selection, material process development, material testing and material specification setting for pilot production of new products. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Maintain contact with customers, appropriate technical sources, and business developments to stay up to date with most current advances and business climate.
• Act as technical spokesperson for Intersect ENT at drug, medical and medical device conferences as aligned with company strategy.

Requirements
EDUCATION REQUIREMENTS AND EXPERIENCE REQUIREMENTS:
• Requires a minimum of a Bachelor’s Degree in chemistry, chemical engineering, pharmaceutical science, materials engineering, polymer science or related discipline, M.S. or Ph.D. degree preferred. Minimum of 8 years’ work experience working with bioresorbable polymers, drug formulation, sustained release, and drug/device combination products in the pharmaceutical and/or medical device industry. An equivalent combination of education and work experience are acceptable.
• Experience in the design and development of drug/ bioresorbable polymer formulations required
• Experience with poorly water soluble compounds with understanding of drug chemical and physical properties and excipients as they relate to formulation, process and drug release. Experience in the formulation of corticosteroids preferred.
• Bioabsorbable polymer processing experience required.
• Bioabsorbable material selection and/or design experience required.
• Experience in topical formulation and excipient selection preferred.
• Experience authoring and/or reviewing the technical sections of the Chemistry and Manufacturing Controls (CMC) section of drug/device combination products regulatory filings preferred.
• Experience authoring answers to technical questions related to CMC, drug formulation, drug-drug interactions, drug tissue interactions and/or bioabsorbable polymer formulation preferred.

OTHER QUALIFICATIONS:
• Excellent communications, project management, personnel management, and time management skills required.
• Knowledge of company products and business strategy required.

PHYSICAL ACTIVITIES: Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.

PHYSICAL REQUIREMENTS:
Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

VISUAL ACUITY AND WORKING CONDITIONS:
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Company

Intersect ENT

Job Code

State or Province

California

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