Summary of Major Responsibilities
The Director, Operations, Biomatrica will be based in San Diego and is responsible for managing the development, planning and implementation of manufacturing methods, processes and operations for new and existing molecular products. This position will lead the overall operations, including facilities, manufacturing production (formulations, filling, and packaging), distribution and warehouse logistics, engineering and metrology, product transfer, quality control, customer service and technical support. In addition, this position will provide oversight around inventory control, and buyer/planner activities. This role will report into the VP, Operations at Exact Sciences Madison and work closely with the Exact Sciences Madison Operations team to establish effective processes, procedures and systems to effectively operate and meet applicable compliance and regulatory requirements. The position will lead and direct complex projects including problem-solving efforts in collaboration with multiple functional departments and align operational execution to meet Biomatrica’s business needs working closely with site leadership.
Essential Duties and Responsibilities
Include but are not limited to the following:
- Lead and manage Biomatrica operations efforts related to facilities and the production and support of non-IVD related molecular products.
- Partner with the business in strategic planning for operations and support of future products and growth.
- Develop and manage the operational budget and capital expenditures including staff and cost centers working closely with VP, Operations, business, and finance partners to achieve agreed upon goals.
- Provide visibility and supporting information to assist leadership in prioritization of projects based on changing functional needs, resource capacity constraints, risk exposure, and ensuring clarity in project interdependencies.
- Clearly communicate expectations, goals, objectives and project deliverables to all levels within Biomatrica and Exact Sciences organization.
- Develop flexible, but consistent processes to deliver high quality products.
- Define principles and standards for implementation of cross-functional initiatives ensuring methodology consistent with company philosophy.
- Oversee operations team defining clear roles, responsibilities and expectations for all levels within given work-streams. Hold team members accountable and takes corrective actions as necessary.
- Mentor, motivate and develop next level supervisors, managers and leaders within functional work-streams to continue to grow talent within our organization.
- Coordinate, lead, mentor, and support process improvement projects within functional work-streams to drive cost savings, efficiencies and productivity. Quantify savings through partnering with financial analysts.
- Establish key metrics and performance indicators as well as assist in developing strategies that drives world-class service, production and quality levels.
- Oversee the schedule of production working closely with appropriate team members cross-site.
- Provide requirements to offsite support teams to ensure adequate material availability for molecular products produced onsite.
- Develop and support the training program for all employees within operations, following best practices to meet ISO requirements.
- Support and comply with the site safety and environmental procedures.
- Partner with quality and safety leaders to maintain compliance to regulatory environments (OSHA, ISO, QMS).
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ensure systems and equipment are calibrated and maintained in the appropriate qualified state for production.
- Manage and oversee the development and maintenance of all SOPs, policies, and programs required for the performance of operational functions working closely with quality and site leadership.
- Ability to use and wear safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, respirator, etc.) and follow safety guidelines within the lab.
- Ability to work with hazardous or flammable materials (e.g. chemicals, radioactivity, electrical equipment) so as not to endanger oneself or others.
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to sit or stand for an extended period of time.
- Ability to travel, by land and air, both domestically and internationally, on occasion.
- Ability to lift and move up to 40 pounds on an occasional basis.
- Bachelor’s degree in Life Sciences, or related field; or high school degree/general education diploma and 4 years of relevant experience in lieu of degree.
- 10+ years of leadership experience in a manufacturing environment.
- Experience in a biotech manufacturing environment preferred, particularly within a cGMP and/or ISO environment.
- Excellent leadership skills to be a primary leader for a diverse team with specialized expertise.
- Ability to effectively communicate to all levels within the company and thrive in a fast-paced, ever changing environment.
- Ability to comprehend procedures, processes and experimental designs to provide guidance and support to teams.
- Ability to course correct when issues arise with strong tactical and clear execution plans.
- Must possess strong coaching/counselling skills to support performance management.
- Proven ability to work effectively cross-functionally in project team situations, influence and collaborate with stakeholders as well as work independently leading teams forward with a clear vision.
- Ability to make decisions based on data and lead teams through ambiguous situations.
- Demonstrated success with oral and written communications/presentations, influence and persuasion, results orientation, facilitation, and teamwork skills.
- Demonstrated ability to manage and prioritize multiple projects and initiatives with excellent project planning and execution skills.
- Strong interpersonal and teamwork skills including the ability to easily convey concepts and priorities to peers, customers and cross-functional teams.
- Hands-on experience in molecular biology techniques.
- Strong documentation skills and attention-to-detail necessary.
- Excellent analytical skills, manufacturing knowledge, and lean principles.
- Experience in using basic software applications including Microsoft Office.
- Ability to frequently and accurately communicate with employees, customers and vendors in person, via telephone or by email.
- Authorization to work in the United States without sponsorship.
- Experience with SAP.
- Master’s degree in Life Sciences, or related field.