Position Title: Sr. Manufacturing Supervisor
FLSA Status: Exempt
Scope of Job
Job Summary: The Senior Manufacturing Supervisor is responsible for leading manufacturing support efforts related to sterile drug Fill-&-Finish (F&F) and device assembly in Redwood City, CA (RWC) facility. Collaboratively leading efforts with Product Development (PD) engineering to implement processes, tooling, and fixtures for products, as well as other responsibilities as assigned.
Receives Direction From: Sr. Director & Team Leader, Manufacturing
Provides Direction To: Team of Assemblers
The individual in this role is responsible for (as well as other responsibilities and tasks, which may be assigned):
• Leading Manufacturing support efforts related to sterile drug Fill-&-Finish (F&F) and device assembly in Redwood City, CA (RWC) facility.
• Collaboratively leading efforts with Product Development (PD) engineering to implement processes, tooling, and fixtures for products.
• Identifying and implementing equipment and/or fixturing for manufacturing efforts.
• Leading and/or actively participating in product/process engineering problem resolution.
• Leading and/or actively participating in process/product improvement projects to ensure quality and cost objectives are met.
• Leading efforts to meet production quotas and associated timelines, ensure product quality levels, maintain compliance with quality/regulatory requirements and 5S principles.
• Managing existing and new service providers and suppliers for RWC facility.
• Conducting training for technical and business processes and ensuring compliance with procedures.
• Identifying resource requirements and maintaining project budgets & schedules.
• Provide leadership when performing component and equipment preparation and drug filling and that processes are performed per quality system requirements.
• Ensure manufacturing documentation is accurately completed in timely manner.
• Ensures that manufacturing data is maintained
• Working with engineering and materials departments to develop BOMs & routings and CTEC databases.
• Assisting with production planning and resource allocation.
• Assisting with efforts to ensure availability of materials (supplies, components, subassemblies, finished goods) and maintain appropriate inventory levels to meet business needs.
• Participating in development/maintenance of product design FMEAs.
• Serving as an independent design reviewer for other projects.
• The individual fulfilling this role will work closely with the company’s Engineering/Product Design, Quality, Clinical, Sales & Marketing, and Finance teams.
• Supporting the manufacturing and operations function for RWC facility.
• Assisting engineering with supplier selection, qualification, and audit programs.
• Negotiating contracts & costs for supplies/services.
• Developing and maintaining documentation to support design control, product configurations (e.g., bills-of-materials), and other Quality System requirements (e.g., SOPs, Standard Operating • Procedures; WIs, Work Instructions) to create and maintain World Class processes.
• Performing productivity and costing analyses (including DL & materials costs for new products, identify and implement cost reduction plans for existing products).
• Support internal and external audits as required.
• Assist with internal and external transfer of knowledge and training as required.
Any combination equivalent to, but not limited to, the following:
• Five or more (5+) years of experience, preferably in GMP sterile manufacturing environment.
• One or more (1+) years of leadership experience.
• Engineering Degree Preferred
• Highly motivated, goal-oriented achiever with ability to prioritize and independently organize work.
• Good mechanical intuition, attention to detail, excellent problem-solving skills, and organization skills.
• Management of product transfer and experience working on/leading cross-functional teams desirable.
• Broad understanding of development processes compliant with 21 CFR 820 and/or ISO 13485.
• Knowledge of and compliance with applicable Quality System requirements (e.g., traceability, QSRs and GMPs, ISO and MDD requirements).
• Knowledge and experience with product, process, and/or software validation.
• Demonstrated ability to establish supplier partnerships.
• Ability to work collaboratively across all functional groups and all levels.
• Proficiency with written and spoken English, strong written and verbal communication skills.
• Ability to effectively create documents and to support partnerships with business partners.
• Proficiency in Microsoft Office applications.
• Able to stand, walk and sit for extended periods of time.
• Able to climb stairs.
• Ability to travel by air, rail, car.
• Able to operate personal computer.
Training in relation to company systems and procedures, as well as individual job duties will be provided by Eyenovia. The need for additional external training with respect to regulations, industry standards, etc. will be determined by employee’s supervisor, and provided as appropriate.
Job descriptions change from time to time. The company retains the right, at its sole discretion, to modify information contained in this job description. Changes in job description will be discussed with the employee at or before implementation.
Eyenovia is an equal opportunity employer. Eyenovia offers a competitive benefits package including medical, dental, vision, PTO and holidays, and matching 401(k).