Work Location: Rockville, Maryland Shift: Department: LS-LS-TGCAE US Ops Routine Immuno Recruiter: Shelby Elizabeth Briggs
This information is for internals only. Please do not share outside of the organization.
Your Role:
As Lab Manager, you will oversee the daily management of a wide variety of assays or tests required to characterize product or material safety. This includes supervision of supervisors, scientists, associate scientists, and/or lab technicians in each lab. This also includes oversight and accountability for quality of work, service delivery, financial targets, and other established lab performance targets. You are responsible for the scientific integrity of technical work performed in manufacturing, and are required to ensure scientific observations, detailed workbooks and all other documentation fulfills generally accepted (GMP/GLP) professional/industry standards. Requirements also include maintaining a thorough understanding of company manufacturing and testing services, technical principles, and applications as they apply to your position.
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.
Scope of Responsibility
Manage and lead multiple laboratories within Product Characterization. This position may have Study Management/Director responsibilities. The lab manager is also responsible for overseeing the development of technical specifications with client input.
Essential Job Functions
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 Product Characterization 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.
Perform other duties as assigned.
Who You Are
Minimum Qualifications:
BA/BS in scientific discipline with 8 or more years relevant experience Or
MA/MS in scientific discipline with 5 or more years relevant experience
Preferred Qualifications
Minimum 5 years' experience leading operations functions
Minimum 5 years' experience with cGMP regulations and regulatory compliance
Knowledge and Skills:
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
Location: Rockville, MD; Onsite role (min 3 days per week)
May be required to work overtime or flexible shifts
Travel: < 10%; International and Domestic
Pay Range for this position: $73,000 - 219,000
Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
