Lab Manager, Viral Clearance Services

Location
20850, Rockville
Posted
Jan 10, 2021
Required Education
Associate Degree
Position Type
Full time

Your role:

The Lab Manager will lead the testing of clinical and commercial products. They are responsible for oversight and overall management of multiple labs and the corresponding metrics. Requirements also include maintaining a thorough understanding of BioReliance services, technical principles and applications.

  • Makes final decisions on operational matters to ensure achievement of department objectives.
  • Effectively deploy the resources within the laboratory and make recommendations to Head of Biologics for required additional resources to facilitate the continued expansion of the business.
  • Drive teams to meet revenue targets while maintaining and controlling associated budgeted expense lines.
  • Drive business and quality metrics to meet company goals: delivery, right first time, repeat rate, etc.
  • Ensure validation requirements are achieved for the laboratories as defined by the company’s Quality System.
  • Interact with Sales/Marketing to develop the business of the company and provide support to the sales team where required.
  • Interact with Quality Systems to continually improve systems and to ensure that new procedures/systems are understood and are effectively implemented within the laboratories.
  • Ensure laboratories are appropriately maintained for compliance to cGMP requirements. This includes supporting client inspections.
  • Interact with Order Management to monitor pricing for work and formulate strategies to improve margins.
  • Interact with other operational leaders and senior management in the organization to promote synergies between departments and more effectively utilize resources.
  • Interact with global colleagues to ensure uniformity of standards and service within the company as well as drive global alignment.
  • Effectively manage resources to ensure full compliance with all regulatory obligations that govern operations.
  • Work with lab supervisors, project management, account managers, and operations scientific staff to ensure routine work is scheduled appropriately to meet client needs and on time delivery expectations.
  • Liaise with continuous improvement and digitization project leads on process improvement efforts. Coordinate resources needed for such projects.
  • Ensure teams comply with company health and safety regulations and procedures.
  • May be required to work overtime or flexible shifts. 

Who you are:

Minimum Qualifications:

  • Master’s degree in a scientific discipline (i.e. Biology, Biochemistry, etc.) with 5+ years relevant laboratory experience – OR –
  • Bachelor’s degree in a scientific discipline (i.e. Biology, Biochemistry, etc.) with 8+ years relevant laboratory experience – OR -
  • Associate’s degree in a scientific discipline (i.e. Biology, Biochemistry, etc.) with 10+ years relevant laboratory experience
  • 5+ years’ experience leading biologics operations
  • 5+ years’ experience with cGMP regulations and regulatory compliance

Preferred Qualifications:

  • Excellent time management skills
  • Strong organization skills
  • Working knowledge of spreadsheets and spreadsheet data analysis tools
  • Excellent oral and written communication skills, both formal and informal that have been demonstrated through presentations/seminars, oversight of projects, etc.
  • Highly collaborative as well as independent
  • Effective coaching and developmental skills for direct reports