Overview:
Kuros Biosciences, Inc. is seeking an
Operations Manager to join our core Operations team to support the build out and running of Kuros' newest manufacturing facility in Alpharetta, Georgia. The Operations Manager owns the execution of Manufacturing KPIs/goals as well as directing, organizing, and controlling all day-to-day US Operations activities and teams. This role establishes the path and leads operations resources to manufacture Kuros' finished product timely to meet customer demand with a safety-first mentality, in the most efficient manner while ensuring sufficient capacity, with the highest quality. Critical success factors for this role include leadership, developing people, sustaining a lean six sigma culture, optimizing resource output, enforcing quality standards and collaborating across departments to support Kuros' strategic objectives.
Key Responsibilities:
- Support build out of a new manufacturing facility with Operations team.
- Develop and implement standard operating procedures (SOPs) to ensure operational efficiency, standard work, and compliance.
- With the support of the VP of US Operations, develop Operations departmental strategy and vision to ensure adherence with customer expectations, enforce consistent and continual improvements, and monitor operations metrics.
- Develop and sustain collection and analysis of Operations KPIs and operation information from multiple sources to develop long-term Operations and Quality strategy and programs. Prepare monthly reporting based on Operations KPIs and present results to Senior Leadership and the ELT.
- With the support of the VP of US Operations, implement plans and procedures that drive achievements of Operations/Quality goals and manufacturing improvements by managing team performance and ensuring team alignment in accomplishing goals and objectives.
- With the utilization of our lean methodologies such as morning markets, manage communications between value streams to ensure Operations is meeting the build schedule and building Quality product that meets customers' expectations.
- Provide leadership and the application of problem-solving initiatives through systemic tools such as lean manufacturing and six sigma.
- Implement and sustain a 6S program to help foster the culture of a world class manufacturing facility.
- Leads production process analyses, ensuring quality standards are met and making recommendations for quality improvements.
- Ensure compliance with regulatory requirements, ISO13485, GMP, company policies, and safety standards.
- Work with engineering in the planning of new tools and fixture designs. Responsible for the design, development, and deployment of equipment and test systems in the manufacturing environment.
- Ensure manufacturing systems that require calibration and maintenance are sustained through an appropriate calibration process and documented appropriately.
- Foster a safety-first mentality while improving efficiencies through the improvement of process flow, elimination of waste, and cost reduction through leadership, example, and training.
- With the support of the VP of US Operations, develop and manage financial budgets for US Operations.
Qualifications & Skills: - Education: Bachelor's degree in Engineering, Biology, or Operational Management required. A Master's degree in related fields or an MBA, preferred.
- Lean Six Sigma Green Belt or Black Belt Certification
- Experience: 5+ years in Operations management in an ISO13485 regulated industry
- Experience with regulatory environments such as GMP, FDA, or ISO standards
- Skills:
- Ability to influence and build strong and trusted working relationships with global internal and external business stakeholders at all levels
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal abilities
- Proven leadership and team management expertise
- Proficiency in lean methodologies and Six Sigma tools
- Proficiency in data analysis tools and software such as minitab, PowerBI, Tableau
- Proficiency in ERP and Masterdata, preferably in Microsoft Dynamics 365
- Experience in developing and continuously improving upon operations KPI's such as manufacturing efficiency, Plant Loading Capacity utilizations, Process Cycle times, Reject/Scrap rates, Inventory Accuracy, First Pass Yield, and Monitoring budget to fiscal year plan
- Travel: Ability to travel internationally
Pay Range
$120,000—$140,000 USD
About Us
Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies.
Our credentials
With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company's first commercial product, MagnetOsTM, is a unique advanced bone graft that has already been used across four continents. For more information on the company, its products and pipeline, visit kurosbio.com.
- Listing on the SIX Swiss Exchange under the symbol KURN
- A commercial & research footprint that spans >20 markets
- 4 teams of internationally renowned clinical and scientific expert advisers
- >25 orthobiologics-related patents
- >400 patients evaluated in Level I, randomized controlled clinical trials
- >20 well-controlled Level I-III clinical trials initiated, including 6 that are complete
- Level I evidence published in Spine
Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros
Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.
