Manager/Director, Analytical Testing Services - Witt/Kieffer : Job Details

About the Organization: Associates of Cape Cod, Inc. (ACC) is your Endotoxin Experts! We manufacture bacterial endotoxin and beta-glucan detection products. The company offers enzymes, muco-polysaccharides, monoclonal antibodies, glyco-conjugates, endoglycosidases, and exo-glycosidases, as well as limulus amebocyte lysate products, serving customers worldwide.

Description

PURPOSE:

In this role, you will manage two contract testing laboratories and 20 employees:

• Contract Test Service: a laboratory specializing in testing for endotoxin and glucan contamination to support pharmaceutical and medical device manufacturers.
• Beacon Diagnostics Laboratory: a CLIA-certified reference laboratory specializing in (1?3)-ß-D-glucan and serum galactomannan (GM) antigen testing to support the diagnosis of Invasive Fungal Disease.

GENERAL RESPONSIBILITIES:

• Ensure that personnel, methods, and standard operating procedures comply with FDA cGMP, ISO 13485, CMS CLIA, and other applicable regulations.
• Manage, mentor, coach, and develop direct staff to meet and exceed individual, departmental, and divisional goals.
• Oversee customer interactions including contract, method development, communication of testing results, response to inquiries, and management of customer audits.
• Manage budget and expenses for the two contract testing laboratories.
• Participate in strategic planning for future business growth.
• Oversee implementation of new training, compliance, software programs, and improvement initiatives.
• Oversee verification and validation of new testing assays for addition to Testing Service Menus.
• Establish departmental metrics for products and processes, trend and report to management.
• Other duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Excellent knowledge of FDA cGMP, ISO 13485, CMS CLIA, and good laboratory practice.
• Ability to work effectively with customers, sales and marketing, and all levels of internal personnel.
• Strong management and training skills.
• Strong project management skills.
• Detail-oriented with excellent organizational skills.
• Able to work in a fast-paced team environment.
• Excellent oral and written communication skills.

EDUCATION AND EXPERIENCE:

A minimum of a master's degree in a scientific or health care discipline, or an equivalent combination of experience and/or education. Advanced degree a plus. Must have at least ten years of experience in the medical device, biotech, or pharmaceutical industry, including management in a contract test service environment.

GENERAL COMPETENCIES:

• Uses resources efficiently and strives to reduce costs.
• Communicates well (written and verbal), delivers presentations, and has good listening skills.
• Good listener, committed to finding solutions to problems.
• Works well with internal and external customers, promoting a positive image of the company.
• Able to reach fact-based decisions and makes thoughtful decisions.
• Honest, accountable, and maintains confidentiality.
• Provides timely and necessary information to team members.
• Takes action, seeks new opportunities, and strives to see projects to completion.
• Creative, offers new ideas, and is amenable to change.
• Builds strong relationships and works well with others.
• Manages workload efficiently and meets goals and objectives.
• Strives to eliminate errors and improve product/services.
• Meets deadlines and establishes appropriate priorities.

PHYSICAL REQUIREMENTS:

Frequently sit, stand, and occasionally walk. Use hands to finger, handle, or feel occasionally. Reach with hands or arms, climb or balance, stoop, kneel, crouch, and/or crawl occasionally. Constantly talking and listening. Occasionally taste or smell. Infrequently exposed to toxic or caustic chemicals. Work environment is very quiet.

BENEFITS:

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

EOE Statement: We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.