Director of Operations
The employees at Hemanext are committed to continuing the effort of the transfusion medicine community to save lives and improve patient outcomes. Our distinctive focus is on innovations systems enabling blood collection, processing, storage and transfusion that will promote radical improvement in the quality, safety, efficacy and cost of transfusion therapies.
We are seeking a plant operations leader for our Avon, MA manufacturing operations. This role is responsible for general supervision of all phases of plant operations including production, production planning, quality control, facilities upkeep and maintenance, receiving, and shipping. Responsibilities also include:
- Ensure safety and efficiency of the facility
- Establishes operation standards for cost control, waste reduction, quality, safety and on-time delivery.
- Business development of the plant against pre-established growth targets that help complement our manufacturing capabilities portfolio.
- Remain in compliance with facility standards and regulatory (ISO and FDA) requirements
- Hiring and training personnel and facility/physical plant up-keep.
- Maintain all administrative records for employees of the facility
- Annual budget planning and execution.
- Work closely with the production team to increase productivity and profitability.
- Establishes and directs the implementation of manufacturing policies in the areas of Lean Manufacturing techniques, materials usage, shipping and receiving, capacity planning, production scheduling, safety, customer satisfaction and performance measurements.
- Participates in selection of key suppliers and contract manufacturers. Oversees the operational activities of contract manufacturing facilities.
- Key member of the Design for Manufacturability team for the Hemanext line of products.
- Deployment of the Hemanext manufacturing work cells as per the manufacturing plans and volume projections.
- Develop and implement a comprehensive preventive maintenance program
- Provide leadership for the successful day-to-day operation of the facility.
- Remove waste and constraints from the production process to improve efficiencies and enhance productivity.
- Communicate with research and development as well as product management personnel to develop new product strategies.
- Work with purchasing to develop and improve supplier relationships and respond to CAPAs when required.
- Work closely with quality personnel to review product consistency while monitoring scrap rates to determine trends and areas of improvement.
- Review established production schedules for all manufacturing departments to ensure established inventory levels are met while operating at the highest efficiency possible.
- Coordinate the hiring and training of all manufacturing personnel.
- Monitor operation expenses and research ways to reduce costs while maintaining product quality.
- Work closely with the Safety Representative to ensure all members of the manufacturing team are aware of safety policies to provide a safe workplace for our employees.
- Maintain and support a superior safety and housekeeping program, including the cleanrooms monitoring and maintenance.
- Develop and execute the plant manufacturing budgets.
- Conduct performance appraisals and provide coaching and guidance to all operations employees.
- Encourage and promote operating in a continuous improvement environment.
- Remove production constraints; allocate human and equipment resources and direct production employees to attain all established goals.
- Maintain physical plant security.
- Help attain ISO certification for the plant.
Behavioral and Interpersonal:
- Strong leadership skills and a cooperative positive attitude is a must to help employees and other managers reach their goals and keep high motivation and morale.
- Strong team building skills as well as established leadership practices such as mentoring, coaching and individual career development.
- Foresees problems rather than simply reacting to them.
- Uses independent judgment to assess operational status and determine the means to overcome production problems.
- Demonstrated ability to prepare estimates and perform resource scheduling.
- Confidently makes competent decisions and takes suitable actions when presented with situations that are unclear or problems that are unfamiliar.
- Must be able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced, entrepreneurial environment
- Takes responsibility for projects, requirements and schedules and deliveries. Must be self-motivated and possess good organizational and communication skills.
- There are direct reports to this position, with opportunity for growth based on company performance and strategic direction.
- This is a highly visible position with exposure to the customer, senior staff and vendors. The position will interact with several departments within the organization. The business and vendor development aspect of the position requires a level of professional acumen reflective of the customer interaction.
Education and Experience Requirements:
- B.S. Degree
- 7+ years progressive experience in a key leadership/management role at a manufacturing facility.
- Previous experience with Medical Device manufacturing and understanding of cGMP.
- Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc. to drive improvement.
- Previous experience/broad understanding of safety systems and enforcement of safety rules and policies.
- Previous experience/strong understanding of budgeting/expense management with a basic understanding of financial and accounting practices.
- Demonstrated understanding of the principles and applications associated with manufacturing operations, maintenance and engineering.
- Experience with sterile disposable medical devices, biocompatibility and process validation is a must.
- Familiar with FDA/QSR, ISO/MDD and applicable industry standards.
- Familiar with DOE, DFM, LEAN and Design for 6 Sigma techniques
- Strong computer skills including the ability to prepare spreadsheets and use Microsoft Office Products (Word, Excel, Power Point and/or Access) .
What Hemanext offers you…
Hemanext is an early stage company founded on a decade of scientific research and innovation and dedicated to bringing advancements in the world of transfusion therapy, and by doing so, dramatically impacting the patient’s quality of life. We want to create what has never been done before for some of our sickest patients.
You will be working alongside some of the brightest, most creative and patient-focused people you will have ever worked with. We are looking for employees who have a passion and hunger to use their educational and professional experiences to achieve our mission. The stakes are high, and we are working a green-field of opportunity to bring about seismic change.
To Apply → Please send your resume to firstname.lastname@example.org or apply through Linkedin.com.