Hybrid Mechanical Testing Lab Manager na Kymanox
Kymanox · King of Prussia, Estados Unidos Da América · Hybrid
- Junior
- Escritório em King of Prussia
Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day-to-day work…
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
Responsibilities:
This position is responsible for laboratory oversight, laboratory safety, equipment and materials management, and coordination of GxP and non-GxP testing at the Kymanox medical device and combination product testing laboratory. This is an on-site position based at the Kymanox site in King of Prussia, Pennsylvania and requires daily presence on site (5 days/week).
Responsibilities include (but are not limited to):
- Oversee sample management, inventory, and reconciliation for GxP and non-GxP studies.
- Order and maintain inventory of laboratory supplies, consumables, and reagents.
- Organize and maintain traceability of test fixtures and instrumentation.
- Act as the primary point of contact with vendors and clients, for shipping and receipt of laboratory supplies and test samples.
- Manage laboratory waste streams and coordinate waste pickup with vendors.
- Manage equipment calibration and maintenance and coordinate scheduling with calibration vendors.
- Ensure sufficiency of laboratory safety procedures and adherence to laboratory safety requirements.
- Support and oversee introduction of new equipment into the laboratory.
- Maintain laboratory audit readiness and perform routine walkthroughs.
- Oversee laboratory cleaning and general maintenance.
- Manage 4-6 laboratory engineers/operators as direct reports. Assign tasks to facilitate timely completion of testing in alignment with project prioritization.
- Collaborate with project teams to coordinate laboratory testing. Maintain a master laboratory schedule for laboratory personnel and equipment resources to support testing activities in accordance with project timelines.
- Act as primary oversight for training on equipment use and test method execution. Serve as a potential escalation point in the event of testing deviations, out of specification results, and equipment malfunctions.
- Work with Quality to ensure compliance with Quality Management System, including evaluating deviations and coordinating testing document reviews, Change Control evaluations, and support for CAPA evaluation and closure.
- Serve as liaison with sales, clients, and project teams to ensure projects are aligned with laboratory capabilities and resources.
- Establish best practices for testing to ensure efficiency and delivery of high-quality testing data.
- Develop and deliver strategic initiatives for improving lab and testing functionality and efficiency.
- Create and/or update applicable Standard Operating Procedures that govern laboratory workflows.
Educational Background:
- Minimum of Bachelor’s degree in scientific, engineering, or other technical discipline from an accredited institution or equivalent.
Experience:
- 5+ years of hands-on experience in testing medical devices or combination products in a laboratory setting is required.
- Familiarity with GxP requirements, FDA/ICH guidance, ISO standards, and USP is required.
- 2+ years of laboratory management experience is required.
- Specific experience with Design Verification activities is preferred.
- 1+ years of project management experience preferred.
- 2+ years of personnel management experience preferred.
- Experience working as a service provider is preferred.
Desired Aptitude and Skill Set:
- Highly organized and excellent attention to detail
- Ability to follow-up on assignments without reminders
- Strong analytical skills
- Fast learner and adaptable to change
- Ability to work with cross-functional teams, both within Kymanox and with clients or suppliers
- Strong planning and management skills
- Adept at proactive and creative problem solving
- Demonstrates strong accountability
- Solution-oriented, eye for improvement and efficiency gains
- Pleasant and positive communication style
- Strong customer-service aptitude
- Thrive in a fast paced, growing, and dynamic work environment
- Ability to follow procedures when they exist
- Appreciation for variety
- Technical writing skills (content and format)
- Adept at Microsoft Office suite of products
- Natural ability to exercise confidentiality and discretion with sensitive information
Travel:
No regular travel requirements are anticipated for this on-site role.
Career Development:
The position may evolve over time and responsibilities will be added. Since Kymanox is a growing company, there will be ample opportunities for advancement – both within the currently defined role, with other groups, and roles to be defined in the future.
Compensation:
Base compensation will be commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for bonus program after 6 months of outstanding work.
Benefits:
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.
