Director/Senior Director, Validation - Hayward, CA | Biospace
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Director/Senior Director, Validation

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:
Director, Validation,

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

The Sr. Director/Director, Corporate Validation provides regulatory and technical guidance and oversees activities for commissioning, qualification and validation (CQV) related to manufacturing facilities, production equipment, and critical utility systems for domestic and oversea locations as well as relevant external CMOs. These encompass new facility/equipment, new functionality, process/equipment changes and modifications, cleaning, sterilization, gamma irradiation and periodic requalification/revalidation.


The incumbent provides overall strategic direction of validation for the company, evaluates and establishes validation requirements for facilities, process, equipment and systems, ensuring that company policies and procedures, applicable regulations and guidelines are followed during project execution and validation life cycle. The incumbent coordinates validation activities with other departments, equipment suppliers and/or contract personnel, and oversees the preparation of project plans, protocols, test scripts and reports throughout all stages of validation from initiation to continuous monitoring.

Duties and Responsibilities:

•   Direct the qualification of manufacturing equipment, facility and critical utility systems.
•   Direct validation of cleaning (CIP and manual), shipping, and sterilization (steam and dry heat) processes.
•   Leadership duties also include managing and providing guidance to both full time employees and contracted personnel performing validation activities. Define scope of work and bid out project, as needed.
•   Oversee the development and execution of FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents, such as commissioning plans and test scripts, commission summary reports.  
•   Direct the development of master plans, validation plans, SOPs, system impact assessments, criticality assessments, risk assessment and validation protocols for new facility/equipment, new functionality/process, process/equipment changes and modifications, and periodic requalification/revalidation.
•   Provide guidance on overall validation strategy, programs and policies. Prepare, review and revise Policies, Master Plans, and SOPs pertaining to governance of validation lifecycle.
•   Oversee the coordination with and interface with management of other departments including Product development, Manufacturing, Engineering, Facilities, and QA/QC.
•   Direct corrective actions including investigating and resolving deviations as relevant to validation.

Requirements


Qualifications:

•   Bachelor's Degree or higher in Engineering, Life Sciences or related disciplines.
•   Hands on experience in developing validation master plans/protocols, field execution, and preparing validation final reports.
•   Expertise in the following areas are required: Facility/Equipment/Utilities Qualification, Cleaning Validation, Sterilization Validation, Process validation (media fill) and Shipping validation. Expertise in Process Validation is a plus.
•   Subject matter expert in both domestic and international GMP regulations (FDA and EMA) and industry guidance documents (e.g. ICH, PDA, ISO, PIC/S, and ISPE), and capable of providing guidance to incorporate continuous improvements and best industry practice into validation activities and policies.
•   Hands on experience with regulatory inspection is a must.
•   Knowledge of Automation Software Validation is a plus.
•   Expertise in applying risk-and science-based validation approaches is a must.
•   Experience with system and process risk assessments; including FMEA, and HAZOP.
•   Knowledge of drug/device combination products is highly desirable.
•   Project Planning or Management experience is a plus.

Skills:

•   In-depth knowledge of pharmaceutical manufacturing of sterile products, aseptic processing, and drug/device combination product manufacturin
•   Exceptional critical and analytical thinking skills, trouble-shooting and problem solving
•   Excellent interpersonal, follow up, and excellent verbal and written communication
•   Exceptional ability to function effectively and proactively in a fast-paced, changing
•   Self-motivated and willing to accept temporary responsibilities outside of initial job
•   Read and interpret drawings such as blueprints, AutoCAD, P&ID,
•   Expert Microsoft Word and Intermediate Microsoft Excel skills are required.
•   Strong team player aligned with lntarcia Corporate Values

Experience:

•   15+ years of relevant validation experience with 5+ years in managing others.
•   Aseptic processing experience is a
•   Experience with Fill/Finish process and isolator technology is highly desirable.
•   10+ years of hands on facility/equipment/utilities qualification experience in a cGMP environment (IQ, OQ, PQ) is required
•   10+ years of hands on cleaning, shipping, and sterilization validation experience in a cGMP environment is required.
•   Media Fill experience is a must.