Senior Engineer/Principal, Process Development

Intarsia Therapeutics, Inc. Hayward , CA 94542

Posted 6 months ago

Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.

At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.

Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.

We Are Growing

Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston's Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.

A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are and intend to remain the driving vision and force behind our progress and our ultimate success.

Your Opportunity:

As a key member of the Development, Technology & Engineering team, the Senior Engineer/Principal, Process Development is responsible for leading, managing, coordinating, and executing Process Development activities. This includes technical analysis and assessment of manufacturing capabilities and manufacturing process robustness. This position will provide leadership to engineers and technicians supporting Process Development and Clinical Manufacturing activities. The Senior Engineer, Process Development will develop and recommend strategies for commercial ready cGMP manufacturing processes and applications.

Duties and Responsibilities:

  • Responsible to develop efficient and scalable manufacturing processes, scale-up and transfer manufacturing processes to commercial manufacturing, and implement new innovative technologies.

  • Lead process development teams and oversee manufacture of clinical supplies.

  • Lead a team of engineers and technicians.

  • Oversee protocol writing for the manufacture of product lots and associated process development reports. Develop realistic timelines for all projects. Provide expertise in process development and engineering including design, process characterization, scale-up, optimization, technology transfer, and equipment qualification.

  • Interface with various departments to ensure processes and designs are compatible for new product requirements and to establish future manufacturing technology.

Qualifications:

  • Degree in Chemical Engineering or equivalent; advanced degree preferred.

  • Experience with sterile cGMP manufacturing and FDA regulations is required; device development experience would be a bonus

  • Demonstrated technical expertise in pharmaceutical formulation, compounding and mixing highly preferred.

Skills:

  • Knowledge of pharmaceutical manufacturing of sterile products, aseptic processing, medical device manufacturing, and manufacturing process development.

  • Ability to think critically and analytically.

  • Excellent verbal and written communication skills with experience communicating both up and down the organization.

  • Strong technical report writing skills.

  • Demonstrated troubleshooting and problem solving skills.

  • Good interpersonal skills and ability to interact with diverse groups.

  • Ability to function efficiently and independently in a fast-paced, changing environment.

  • Well-developed skills with Microsoft Office software.

  • Strong team player aligned with Intarcia Corporate Values with a "can do" and flexible attitude who is able to work efficiently and productively in a highly dynamic and high-performing team environment.

Experience:

  • 8+ years of pharmaceutical manufacturing & development experience is desired

  • Pharmaceutical sterile products manufacturing and aseptic processing experience is required

  • Medical device manufacturing experience would be advantageous

  • Technology transfer experience a plus

(No relocation/Local candidates only)


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Senior Engineer/Principal, Process Development

Intarsia Therapeutics, Inc.