Principal/Senior Eng, Eng III, Process Engineering - Hayward, CA | Biospace
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Principal/Senior Eng, Eng III, Process Engineering

Intarcia Therapeutics, Inc.

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Location:
Hayward, CA
Posted Date:
7/20/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Engineering, Process, Process Engineer,

Job Description


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

Intarcia Therapeutics is seeking a Principal/Senior Engineer / Engineer III, Process Engineering to lead engineering efforts in facility expansion and capital projects in order to support process scale-up of the spray drying, mixing, filling and finishing operations. These activities are essential to meet commercial launch and post-marketing demands consistent with regulatory requirements and Company policies, procedures and goals.

Duties and Responsibilities:

•   The incumbent will play a key role in capital projects related to facility expansion and equipment/process scale-up projects
•   The incumbent will work with other functional areas staff to ensure the readiness of our facility through efficient and robust execution of expansion and on-going process improvement while meeting current regulatory and compliance expectations for combination drug/device products.
•   Support and implement new equipment design, new products and ongoing capacity expansion projects including Conceptual, BOD, Detailed Design, Construction and Commissioning phases.
•   Prepare URS, P&IDs as directed, and manage/support FAT, SAT and IOQ activities.
•   Implement and execute project implementation strategy by providing oversight on cost, schedule, scope and quality.
•   Keep track on project progress and inform management of potential risk to business during project execution phases.
•   Manage outside contractors, A&E and CM companies during design and construction phases and ensure compliance of applicable regulations.

Requirements


Skills

•   Working knowledge of scientific and engineering principles (heat and mass transfer, fluid dynamics, analytical methods, and protein stability).
•   Experience working with equipment vendors to design complex mechanical equipment.
•   Experience with clean utilities including WFI and clean steam.
•   Working knowledge of auxiliary equipment such as autoclave, parts washer, and depyrogenation oven.
•   Practical experience in aseptic fill and finish operations.
•   Demonstrated knowledge of pharmaceutical manufacturing of sterile products, aseptic processing, medical device manufacturing, and process development.
•   Read and interpret drawings such as blueprints, AutoCAD, P&ID, PLC.
•   Well-developed skills with Microsoft Office
•   Experience managing in a commercial pharmaceutical production environment a plus.

Qualifications:

•   BS/MS degree in Chemical or Mechanical  Engineering with at least 10+ years of relevant experience (8 year for senior engineer, and 6 years for Engineer III)
•   Strong understanding of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
•   Must demonstrate the ability to think critically and analytically and demonstrated troubleshooting and problem solving skills  
•   Good interpersonal, follow up, and excellent verbal and written communication skills
•   Ability to function efficiently in a fast-paced, changing environment
•   Self-motivated and willing to accept temporary responsibilities outside of initial job description
•   Strong team player aligned with lntarcia Corporate Values