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A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

Are you a seasoned leader with a passion for operational excellence and team development? We are seeking a Manager, Manufacturing to join our Carlsbad, CA team. In this role, you will provide critical leadership, development, and operational expertise to our manufacturing team and cross-functional groups. You will be instrumental in developing, communicating, and executing both short-term tactical goals and long-range strategic objectives. Your leadership will drive the manufacturing teams to achieve departmental and company milestones, meet New Product Development timelines, and maintain a culture that prioritizes Quality, Compliance, and Continuous Improvement through LEAN initiatives. If you are driven by a commitment to excellence and thrive in a dynamic, innovative environment, we would love to have you on board.

The Opportunity

Manage production leaders across three shifts and their direct reports on multiple product lines.

Assist with developing and executing tactical and strategic plans to meet forecast build plans and new product requirements.

Develop and partner with the team to execute manufacturing training plans ensuring proper resources and coverage for manufacturing requirements.

Develop, implement, analyze, summarize and report key performance indicator data and metrics for areas of responsibility. Responsible for identification of root cause and implementation of sustainable corrective actions for missed targets. Assist support teams to investigate quality issues.

Responsible for ensuring compliance to governing quality systems, product specifications, process instructions, safety requirements and company policies. Work together with the assigned team to identify, separate, investigate with proposed actions and document non-conformances in the manufacturing process.

Collaborate with and provide manufacturing input and support to New Product teams, including the design for manufacturing (DFM) guidance, input on process / tooling development and developing/refining manufacturing instructions

Provide leadership and coaching to build an effective team, drive continuous improvement, maintain proper inventory management, and conduct annual performance evaluations for direct reports.

Who you are

B.S. degree in Engineering or equivalent. 

Minimum of 5+ years of experience in management of exempt level personnel in a Manufacturing and/or Operations environment in the biotech, medical device, pharmaceutical or similarly regulated industry. 

Skills – Technical

Experience, training, and/or certification in LEAN Manufacturing principles and/or Six Sigma methodologies. Experience with Statistical Process Control is a plus.

Knowledge of quality system requirements (QSR), Good Manufacturing Practices (GMP), and FDA regulations. Experience with cleanroom environments and environmental procedures.

Proficiency in manufacturing/MRP systems, with SAP preferred. Strong hands-on approach with a sense of urgency, discipline, and organization.

Skills – General

Strong time management, delegation, and organizational skills in a dynamic environment. Effective interpersonal communication skills, and the ability to interact professionally at all levels within the organization.

Ability to write, comprehend, edit, and analyze complex documents. Capability to build respectful working relationships with support teams and demonstrate strong analytical problem-solving, judgment, and decision-making skills.

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.

Relocation benefits are available for this posting.

The expected salary range for this position based on the primary location of California is $102,800-191,000. 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.

Benefits

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.