Lab Analytics Team Lead

Role details

About Us

Poly-Med is the leading developer of bioresorbable polymers and fibers. We help innovative medical device companies focused on improving patient outcomes. Poly-Med designs, develops and manufactures superior materials to get customer products to market in the most efficient manner with the greatest improvement to quality of life. Located in Anderson, South Carolina, Poly-Med, Inc. has been recognized as a leader in the industry for over 20 years. Poly-Med continues to grow in a multitude of medical device modalities.

Our novel materials are key in actively enabling products ranging from vascular stents, hernia meshes, dental delivery systems, dental hygiene, and a variety of wound closure applications in the worldwide medical device market.

For additional information, visit our website at www.Poly-Med.com.

Our Team

We employ a widely diverse team comprised of experts from material science, chemical engineering, mechanical engineering, bioengineering, biology, business marketing, and project management to create a work environment focused on solving tough medically related problems. Our team is energetic, resourceful, and, above all, collaborative. We are searching for like-minded talent to build on our success and continue our quest to improve patient outcomes through novel polymeric and drug delivery systems.

Description

Responsible for overseeing analytics group at Poly-Med. Works independently with minimal supervision and guidance. Has broad knowledge of chemistry, chemical analyses, commonly used concepts, practices, and procedures within the analytics field. Relies on personal experience and judgment to perform primary job functions, troubleshoot, make improvements, set-up and oversee processes and laboratory systems.

Scope

This role is a lead role with direct reports. Interaction is potentially with all levels of the organization. This position will train and give day-to-day supervision to the analytics group, and reports to the Manager, Analytics. This role will create and maintain a service-based organizational model for the Analytics Group, providing testing and test method development.

Position Duties for Analytics Lab Team Lead

• Responsible for QA system in labs.
• Responsible for all assigned lab facilities and equipment at all PMI locations.
• Responsible for centralizing test method development into the analytics group.
• Ensure analytics group is sufficiently knowledgeable, trained and experienced to perform their functions.
• Ensure laboratories operate in compliance with GMP and ISO 13485 requirements, as well as other applicable requirements.
• Provide infrastructure, tools, equipment, and support for analytics group to perform required duties.
• Set annual team goals and ensure the team meets those goals.
• Ensure QC and Analytics work together to achieve key performance criteria.
• Determine departmental and testing costs and work within a budget as required.
• Participate in lab equipment selection and purchasing.
• Assist in troubleshooting and seeking resolution to equipment or analytical issues encountered during laboratory testing.
• Conduct and/or assist with laboratory investigations, determine root cause, and implement corrective action as needed.
• Recommend and implement laboratory process improvements with the approval of Quality Manager.
• 1Set and achieve goals for quality, financial, and performance metrics set by management.
• Participate in selection and hiring of staff, discipline, staff development and promotion, as required.
• Responsible for revising test methods and SOPs, as needed, for clarification and/or continuous improvement.
• Performs other duties as assigned by Management.

Requirements

Bachelor’s Degree in Chemistry, Material Science or related Science field

Ideal 2-4 years of experience in medical device, pharmaceutical or similarly cGMP/ISO regulated industry at a Scientist level or above, and supervisory or leadership experience

Working Conditions at Poly-Med, Inc.:

At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.

Physical Requirements

Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans. We do not offer sponsorship at this time.

Job Type: Full-time

Pay: $75,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Application Question(s):

• Will you now or in the future require employer sponsorship for employment visa status (e.g., H-1B)?

Education:

• Master's (Preferred)

Experience:

• validation protocols: 2 years (Preferred)
• Technical writing: 3 years (Required)
• Mechanical troubleshooting: 1 year (Preferred)
• ISO 13485: 1 year (Required)
• test method development: 3 years (Required)
• Analytical chemistry: 3 years (Required)
• Management: 1 year (Required)
• Leadership: 1 year (Required)

Work Location: In person