Mechanical Testing Lab Manager - Kymanox : Job Details

DescriptionIs 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. About Kymanox: Join Kymanox - a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today's biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox's service offerings and the life science industry as a whole. Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC and we have offices in Pennsylvania along with Boston. To learn more about our company, please visit our website: Life Science Solutions Kymanox Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.