Manager, New Product Transfer / Sr Manager

This position may be hired at various levels, depending on experience.

POSITION SUMMARY

The New Product Transfer Senior Manager leads a team of Scientists and Engineers that coordinate with Development, Regulatory and Project teams at GenMark/Roche to launch new assays, including new consumables, equipment and platforms. They will manage a design transfer engineering team, responsible for developing and implementing operation requirements for design transfer across all product portfolios and collaborates with development, manufacturing and technical support teams to assure that all aspects of design for quality and manufacturability are utilized for robust design development, transfer and ultimately scale up. The candidate will partner with the Engineering R&D, Engineering Manufacturing and Quality Assurance teams to assure appropriate test method validations and product specifications are developed and implemented. This leader will foster a strong attitude of collaboration among multiple functional teams within the organization.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Establish overall team direction and goals, and effectively assess resources toward completion of goals, in conjunction with Director of Product Transfer, and Senior Leadership in both Development and Operations. Promote an open, collaborative environment focused on team work.

• Manage the design transfer engineering team, including technical oversight, professional development and hiring qualified personnel.

• Lead the cross-functional team members to transfer new product’s consumables and engineering process, test methods prior to new product launch

• Partner with R&D Engineering members for developing or improving manufacturing process, e.g. Injection, molding, machining and assembly automation.

• Manage external raw material supply, critical raw materials for new product introduction, production scale up, collaboration with supply chain and R&D engineering teams

• Direct team’s Design of Experiments (DOE) and characterization studies as identified by risk analysis

• Manage Engineering Change Orders, such as BOM, SPECs, Manufacturing work instructions related to product transfer activities.

• Define and implement new product’s process control such as SPC, CTQ scorecard, process capability analysis

• Manage new consumable test method validation and manufacturing process validation

• Work with suppliers and contract manufacturers on technology transfer, new process implementation to the manufacturing engineering teams

• Apply standard project management tools, processes and principles to ensure project success, ensure that sound decision making principles and agreements are followed and develop team agreements.

• Serve as advocate and role model for integrating change into the organization as well as serve as departmental role model of professional behavior and presence.

POSITION REQUIREMENTS

(This position may be hired at various levels, depending on experience.)

Education and Experience for Sr Manager:

• B.S. degree or advanced degree in life sciences, engineering or scientific discipline

• BS degree with 10+ years of related experience or MS degree with 6+ years related experience

• Minimum 8+ years progressively responsible in people management and leadership experience in related industry

• 5+ experience in regulated industry preferably FDA and knowledge of Design

• Control guidelines

Education and Experience for Manager:

• B.S. degree or advanced degree in life sciences, engineering or scientific discipline

• BS degree with 8+ years of related experience or MS degree with 4+ years related experience

• Minimum 2+ years progressively responsible in people management and leadership experience in related industry

• 5+ years experience in regulated industry preferably FDA and knowledge of Design Control guidelines

Skills – Technical

• Biochemical – knowledge and extensive hands-on experience with mathematical calculations pertaining to chemical formulations, enzyme activity assays, and a thorough understanding of current molecular biology techniques.

• Experience with evaluating and transferring injection molded components, PCBs and other plastics/consumables into a manufacturing environment desirable

• Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.

• In-depth experience with process and product validations, specification setting and test method validations, and FDA design control documentation is required.

• Excellent Project Management successes with expertise influencing key decision makers within a matrix environment

• Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred

Skills – General

• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential

• Experience leading design transfer activities for medical devices in international markets is a plus.

• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner.

CERTIFICATIONS, LICENSES, REGISTRATIONS (if applicable)

• Six sigma Green belt or Black Belt, and project management certifications are highly desirable.

SUPERVISORY RESPONSIBILITIES (if applicable)

• Ability to manage a team of engineers, scientist and research associates working on diverse new products.

• Demonstrated ability to lead, mentor and coach team members

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 approved for this position.

The expected salary range for this position based on the primary location for this position of California for the Sr Manager is $117,000- 217,400; and for the Manager is $92,500 - $171,700. 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.