Head of MSAT (Manufacturing Science and Technology)

This position will serve as a highly technical, dynamic leader playing a critical role in developing expanded capabilities within Operations. This position will develop key Technical Operations support functions to support current products and new products for product launch. Specifically this individual leads the Manufacturing, Science and Technology (MSAT) team responsible for the following: supporting the design, development and transfer of new molecular diagnostic products to commercial production; technical transfer of products and processes within the global manufacturing network or to OEM partners; product and process improvements; managing data analytics and elaborating recommendations for GenMark in development and on market products.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Root cause investigation of product and process issues, product technical support efforts both internal and customer-interfacing, complaint management activities and internal product training.

• Responsible for safe, reliable, cost-effective and efficient operation of the Manufacturing, Science and Technology (MSAT) function

• Responsible to enable excellence in manufacturing by providing manufacturing support to the production organizations that results in safe, high quality and continuously improving production

• Responsible for:

  • Design Transfer

  • Data Analytics

  • Technical Product Transfers

  • Investigations Management

  • Production process monitoring and improvements

  • Production Equipment Performance Qualification

  • Production process and clean utility validation

  • Scientific Technical support for manufacturing

• Ensure 'Right to Operate' through compliance with all applicable GMP, SHE and other global and local regulatory requirements as well as Roche's Quality and SHE policies and standards

• Ensure compliance with Roche's Group Code of Conduct

• Ensure product market demands are met safely and delivering quality products in adequate time and quantities

• As a member of the site leadership team, advises on key and operations related issues, initiatives and strategy for continuous improving the site operations performance

Develop and lead teams responsible for:

• Failure investigation/product reliability activities based on field performance issues, as well as manufacturability or internal quality needs.

• Continuing support activities for all on-market products and platforms, as well as developing the strengths and capabilities required to support the new platform.

• Identifying, developing and implementing continuous improvement initiatives including product and process improvements, cost improvements, and product reliability.

• Driving on-going improvements to consumable designs based on Manufacturing, Quality and field performance data.

• Scientific Technical support for Supply Chain vendor qualification and evaluation.

• Monitoring Statistical Process Control data and driving implementation of corrective actions or improvements based on those data.

• Engineers, biologists, and RAs charged with providing technical support of our platform to Manufacturing, Quality Control, Technical Services and other areas of the organization as necessary.

• Partnering with the Manufacturing Engineering and R&D Design Transfer teams to:

  • Ensure smooth introduction and ongoing support of new products into manufacturing;

  • Efficient implementation product and process improvements;

  • Effective feedback on product reliability investigations to incorporate "Lessons Learned" into the upstream pipeline.

• Capitalizing on the strengths of the existing team, identifying and recruiting for organization expansion.

• Establishing operational objectives, strategies and work plans to improve current operations as well as planning for future products and customer requirements.

POSITION REQUIREMENTS

Education and Experience

• A Master's degree in Science (e.g. Biological Science, Biomedical or Chemical Engineering) Required

• Preferred: PhD

• 10 years of experience in an Operations setting in a Biotechnology, Medical Device or Pharmaceutical manufacturing environment.

• Extensive experience of Diagnostic reagent manufacturing processes, technical transfers, investigation management and data analytics

• Extensive experience with validation of manufacturing equipment, clean utility and process systems, including requirements for documentation and testing

• Knowledge of Roche internal and external quality and regulatory requirements

• Proven track record of consensus building and conflict management in challenging or difficult situations

Skills - Technical

• Technical Product Transfers: managing technical product transfer teams for new products / processes by partnering with global and site functions

• Investigation management: manage the team to respond to and proactively identify issues, determine root causes and solve them sustainable; CAPA management collaboration

• Validation: own, execute and improve the validation program for production equipment, clean utilities and processes and ensure compliance with QMS and all applicable regulatory requirements. Represent validation program during inspections

• Optimize MSAT output and labor efficiency while meeting required safety and quality levels

• Collaborate closely with global and site functions

• Ensure that staff are appropriately trained and qualified for the activities they perform

• An understanding of design control elements required for medical or in-vitro diagnostics devices.

• Able to apply principles of mechanics, microfluidics, and materials to understand the mechanical design of complex plastic parts and assemblies.

• Able to apply basic biological principles including nucleic acid sample preparation and PCR amplification to understand assay performance on the consumable platform.

• Advanced experience with root cause analysis, design of experiments, and data analysis.

• Experience with qualification, verification, and validation requirements as related to parts, equipment and products.

Skills - General

• Demonstrated leadership skills for people management and development

• Demonstrated business and technical acumen

• Effective communication skills

• Effective continuous improvement expertise

• Experienced in negotiation / influencing / persuasion

• Leadership driven problem-solving skills with proven abilities to anticipate issues and recommend effective and efficient solution

• High cultural awareness and proven ability to work and collaborate with a broad range of cultures

• Demonstrated successful Project Management skills

• Hands-on Budgeting, Finance & Cost awareness

• Neutral, non-biased analytical and strategic thinking

• Presentation skills

• Facilitation and conflict resolution skills

• Consistent delivery of timely, accurate and thorough work product

• Production of accurate, complete, and concise documentation of results

• Able to think and work both tactically and strategically to meet financial and operational needs for GenMark's business.

• Effective analytical problem solving and decision making skills

• Strong time management and organizational skills in a dynamic, continually changing environment.

• Strong communication skills including the ability to communicate with all levels within the organization. Must be able to interact well with individual contributors as well as senior management

LEADERSHIP RESPONSIBILITIES

• Create an environment of strong team spirit and motivate and inspire teams to achieve ambitious goals in short, mid and longer term

• Ensure timely and effective communications

• Establish ambitious goals in line with GenMarks value proposition and objectives

• Drive collaboration within site and across the network

• Manage performance and ensure talent development for all direct functional reports

• Manage the department population towards the set headcount target

• Recruit highly qualified people in a timely fashion

• Exemplify the Roche Values and Leadership Commitments

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

The expected salary range for this position based on the primary location of California is $184,800-$343,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.