Labcorp Drug Development is a global, world-leading Life Science Contract Research Organization that provides dedicated and fully comprehensive laboratory testing and drug development services to the pharmaceutical industry.

At Labcorp, we offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. We put our trust in science and in one another. This is your chance to become part of a team that helps to bring the miracles of medicine to market sooner, as Labcorp Drug Development has helped pharmaceutical and biotech companies develop one-third of all prescription medicines on the market today.

Essential Duties and Responsibilities:

Leads Baltimore manufacturing team responsible for the delivery of kits to internal and external customers within a compliant in vitro diagnostic (IVD) manufacturing environment. This role will directly supervise the day-to-day activities of manufacturing, including kitted product fill-finish, quality control testing, and kit assembly. The role will also support facilities management. The Manufacturing Manager will be responsible for safety, quality, on-time delivery, and cost-effectiveness of Baltimore Labcorp kit production operations. 

Responsibilities:

• Leader for Baltimore Labcorp Manufacturing, including:
  • Fill-finish (manual and automated)
  • Kit assembly
  • Quality control testing, inclusive of general molecular biology laboratory techniques and next generation sequencing (NGS) procedures
• Partners cross-functionally to understand both internal & external customer needs and issues and ensures that manufacturing activities satisfactorily deliver a high standard of service.
• Ensures product is delivered to internal and external customers at necessary scale, on time, and with high quality.
• Collaborates with supply chain team and assists in the planning and scheduling of product manufacturing
• Assures all product produced meets all established quality guidelines and all operations meet GMP requirements
• Supervises and directs personnel within the department
• Develops and implements procedures to optimize resources and achieve volume, timeliness, reliability, and safety standards.
• Supports Baltimore site warehouse operations inclusive of the receiving, handling, storing, picking, packing, and shipping activities of the site to support the production and product development activities on site.
• Develops, monitors, and reports KPIs, including but not limited to metrics such as productivity, cycle time, re-test rates, “right the first time” (RTFT) percentage, and on time-delivery. 
• Responsible for timely resolution of quality events and CAPAs within the department
• Supports laboratory & facilities management at site, inclusive of basic equipment operation and maintenance, space planning, and emergency response.
• Adapt and develop people, culture, and operation to ensure alignment with business unit objectives and customer requirements.
• Ensures adequate resources and processes are available to support production volume. Evaluates, adjusts, and manages workforce planning/staffing levels based on business unit insights, orders, and demand.
• Assesses manufacturing operations for inefficiencies and addresses through the continuous improvement of current processes, methods, systems, and workforce utilization. Fosters a continuous improvement culture within the team and across the department.
• Ensures adherence to all quality and regulatory standard operating procedures through collaboration with the quality team to identify and mitigate quality risk factors.
• Effectively hire, train, develop, and evaluate staff in alignment with business needs. Take corrective action as necessary on a timely basis and in accordance with company policy. Ensure compliance with current federal, state, and local regulations in consultation with Human Resources as appropriate.

Education and/or Work Experience Requirements:

• BS with 5 years’ experience in an IVD, pharmaceutical or biotechnology company, MS/PhD with 3 years’ experience
• Demonstrated knowledge of ISO and/or cGMP
• Experience in 510k and/or PMA IVD manufacturing required
• Experience supervising or managing teams required
• Strong organizational skills and attention to detail
• Strong project management skills
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
• Excellent computer proficiency (MS Office – Word, Excel and Outlook)

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here. 

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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