Miroculus is looking for a motivated, hands-on, and analytical Manufacturing Operations Lead to drive high standards for implementation of our Next Generation Sequencing Sample Preparation product strategy and portfolio.
Miroculus uses proprietary digital microfluidics technology to automate and miniaturize the most complex genomic protocols such as NGS library prep, synthetic biology, cell editing, and combinatorial chemistry, in a compact, user-friendly system. Our vision is to make the most complex protocols easy and accessible to scientists everywhere.
As the Manufacturing Operations Lead, the individual will act as the single point of contact for external manufacturing partners and vendors, be responsible for manufacturing oversight of the company portfolio, and ensure that products adhere to company quality standards and all regulatory requirements while also ensuring that high-quality product is available when needed. The individual will participate in negotiations with suppliers to implement proactive production philosophies, improved pricing, inventory health, strategies, policies, and procedures.
This position reports to the Director of Systems Development.
- Review batch records and operating procedures relevant to manufacturing operations to ensure that proper documentation is in place, current, and maintained in accordance with applicable regulatory requirements.
- Lead relationships and work collaboratively with third party site representatives to ensure consistent adherence to quality contracts and manufacturing standards and product specifications. Support third party manufacturing by providing technical expertise in the manufacturing area and provide support for manufacturing investigations.
- Operate as project manager on technology transfer projects, including planning/execution, financial planning, and management reporting.
- Partner with contract site representatives on scale-up, process optimization, technology transfer and/or validation activities and method transfers to contract partners.
- Enterprise Resource Planning (ERP) experience in a manufacturing environment. Responsible for developing, maintaining, and implementing strategic and optimal production plans.
- Coordinate the planning of schedules and inventory control parameters for the assigned products and services consistent with ERP requirements or as arranged with requisitioners.
- Initiate purchase orders and amendments for parts, services, and/or special tools; arrange for submission and inspection of sample products as required; maintain close coordination with plant engineering to ensure timely execution of product and service sourcing activities.
- Secure and analyze quotations, negotiate prices and terms with suppliers, and recommend suppliers based on cost, quality, and delivery competitiveness for assigned responsibilities.
- Manage supplier relationships with current and prospective suppliers to determine supply capabilities and transportation logistics inventory control and management; negotiate prices and delivery terms
- Work closely with R&D functional groups to ensure manufacturing compliance to applicable standards (external and internal) such as IEC 60601, 61010, 62304, 62366-1, CE-IVDR, US-IVD, RoHS, REACH, and WEEE.
- Support the R&D teams in the development of raw material and component specifications and the requirements of supplier qualification.
- Support external contract manufacturing in process validation and control planning.
- Provide design-for-manufacturing and design-for-service feedback during the development process.
- Provide feedback to the bill of materials (BOM) and coordinate BOM changes throughout the supply chain and supplier qualification.
- Define and lead activities for transfer of new products to external manufacturing.
- Lead process FMEA (pFMEA) assessment and risk management strategy.
- Develop process control points to minimize risk to product.
- Apply GMP principles to assembly and test procedures and documentation.
- Support qualification and validation activities for manufacturing processes or equipment.
- Bachelor’s Degree in life sciences or engineering or related field; MBA preferred.
- 7-10 years of relevant experience in Manufacturing Operations and leadership roles.
- Strong analytical skills combined with practical business acumen.
- Demonstrated ability in building relationships across various functional teams.
- Demonstrated ability in managing multiple tasks within tight deadlines.
- Demonstrated ability to exercise influence and informal leadership.
- An approachable individual who provides a high level of teamwork and cross-functional collaboration.
- Travel estimate: Up to 25%
Strong plus: - Experience within a start-up or small manufacturing operation highly desirable. - Strong project management experience; PMP certification preferred. - Working knowledge of scientific process and validation methods - Quality audit experience - Regulatory Affairs Certification - Capital equipment assembly and test experience
San Francisco, California
Applicants should send a cover letter and resume to firstname.lastname@example.org
Miroculus believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.