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Search for Jobs by Sheryl Horowitz

Principal Engineer, Delivery Systems (Science & Biotech)
Durham , NC 27703
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: May 10, 2019
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Job Description

Job Title: Principal Engineer, Delivery Systems

Our client, a growing global pharmaceutical company, is seeking qualified candidates for a full-time Principal Engineer, Delivery Systems Development position in R&D, Implant Manufacturing division located in Durham, NC. This position will be responsible for driving the development and manufacture of implant delivery devices used for their extended-release, sterile, ophthalmic products from early pre-clinical development through phase 3 clinical studies.

Essential Duties & Responsibilities:

This position will be responsible for driving the design and development of implant delivery devices used for ophthalmic application along with generating drug product interface requirements for the device-implant delivery path. Leadership in material evaluation, test method development and overall product/process risk assessment will be required. Evaluation of environmental impact as well as supply chain design for clinical and commercial implant and delivery products will also be key responsibilities. Interface and integration of design with the drug product manufacturing processes from the formulation development group is essential. Establishing integrated process optimization processes (internal and external manufacture) and scale-up manufacturing, including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) supplies will be required. The most important responsibility will be to establish and maintain relationships with high expectations and high levels of delivery for our internal and external suppliers, while developing a safe and effective delivery systems for developmental drug products. The position may support both aseptically manufactured and terminally sterilized products and/or devices.

This position will work closely with the formulation, non-clinical, clinical, regulatory, quality, and analytical teams. Provide leadership and support for drug product manufacturing activities conducted by third-party manufacturers (CMOs) and vendors.

The Principal Engineer will also write, review and approve of Applicator Assembly, Manufacturing and Controls (CMC) documents, including development protocols and reports, and maintain compliance with GLP and cGMP standards as appropriate for pre-clinical and clinical development.

Direct Responsibilities:

• Develop manufacturing plans for extended release products and delivery systems from pre-clinical through phase 3 clinical development

• Provide technical leadership for the development, tech transfer, and qualification of manufacturing processes for sterile drug delivery systems in non-clinical (GLP and non-GLP) and cGMP clinical development

• Responsibilities will include concept development, prototyping, product design, verification/validation testing, which will include authoring protocols/technical reports, and support through production scale up and transfer.

• Create and maintain design control related documentation such as risk and usability assessments, user needs, design Inputs, etc. Comply with requirements of design controls and other regulatory bodies for direct contributions to regulatory submissions.

• Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs)

• Take a leadership role in the development of material specifications, performance and shelf-life estimates

• Create and review project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time and within budget

• Interface with marketing, physicians and key opinion leaders will be required

• Communicate project status to management and project leadership

• Effectively work within the Development department and with cross-functional team leaders to achieve corporate and program goals

• Help ensure overall operational spend is within the approved budget and timeline

Education and experience:

• BS/MS degree in a related field with 10 years of cGMP drug product and/or medical device development experience

• Previous project/program management and hands-on experience in pharmaceutical process development, device design, and drug product manufacturing is required

• A understanding of CFR Parts 210, and 211, ICH and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications

• Ability to travel domestically and internationally up to 25% required

• Previous experience with process development/manufacturing for extended-release dosage forms or devices, absorbable and non absorbable implants, polymer processing or injectable devices preferred

• Excellent interpersonal verbal, written and presentation skills in communication with internal and external customers

• Strong team player with collaborative style working with both internal and external resources and stakeholders.