Kelly Services is actively recruiting for a Sr. Manager of Technical Operations in Lexington, MA for a Direct Hire within the Biotechnology Industry.
: Sr. Manager, Technical Operations
As a Senior Manager, Operations Technical Support you will be responsible for the technical support, validation ownership, process development, design transfer, manufacturing improvement programs, and cost reduction programs for all products in the Reagent, Cartridge, and Micro business units. This position will report directly to the Director, Operations.
• Identify and implement best practices in all aspects of operational effectiveness of the Company's global manufacturing, quality control and service activities.
• Ensure compliance with 21 CFR Parts 801 Labeling and 820 Quality System Regulation and ISO 13485 Quality System Regulations.
• Build, develop and lead a high-performance Operations – Technical Support team of research associates, scientists and engineers.
• Lead company-wide verification testing activities to support regulatory clearance submissions.
• Conduct risk management activities to minimize risks associated with manufacturing, quality control and service operations.
• Maintain, improve, and update Master Validation Plans for all current and future products within the Client pipeline to ensure compliance, improved product quality, and process efficiency for our reagent, consumable, and micro product lines.
• Optimize and improve manufacturing and quality control processes by designing and conducting process development programs; applying knowledge of reagent design, formulation, and fill best practices.
• Attend new product development meetings as a core team member. Provide design for manufacturing input to R&D, and lead scale-up, process development, and transfer activities for both MFG and QC. Participate in new product development design reviews.
• Assist in root cause analysis on purchased part or internal product quality issues.
• Manage corrective actions for product non-conformances, deviations, and product complaints related to manufacturing process or test method improvements.
• Review performance against program schedules, provide reports, interpret results, and approve changes in plans.
• Assure product and process quality by establishing standards, designing testing methods, testing finished product and process capabilities, and confirming manufacturing processes.
• Work with suppliers and Client's internal manufacturing to implement sustaining and cost reduction activities.
• An advanced Engineering degree, Science degree, or MBA.
• A minimum of 5-8 years management experience in a regulated manufacturing environment in production of biological products, including nucleic acids, reagents and automated assay systems.
• Experience in leading direct reports by delegating responsibilities, motiving team members and developing career plans.
• Proven medical device (ideally within complex IVD environment) operations experience.
• Experience identifying and mitigating risks associated with design for production.
• Experience working with partners such as contract manufacturers, distribution centers, and suppliers.
• Experience in multiple areas such as engineering, operations, quality, materials, logistics, supply chain, and customer service. Proven experience in examining and re-engineering operations and procedures, formulating policy and developing and implementing new strategies and procedures.
• A proven track record of commercializing FDA regulated products on time and on budget.
A few “must haves”:
- Management experience
- Reagent Development
- Product transfer
- Validation and an understanding of the process
- Process development
- Development transfer of an FDA product
- Should be an expert in validation
• Independent thinking, strong organizational and planning abilities, excellent analytical and problem solving skills, strong business acumen and the ability to multi-task is essential.
• A strong drive to succeed coupled with excellent interpersonal and leadership skills to coach, mentor and tap the desire of employees to excel as individuals and on teams.
• Proven ability to work effectively in a growing environment at multiple levels of management and company leadership; a true team player.
• Result orientated, decision maker with the ability to recognize and support the organization's priorities.
• High level of communications skills – both written and verbal.
If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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