Director, Lab Operations

Agawam, Massachusetts, United States Full-time

Position Title:  Director, Lab Operations
Job Location(s): Agawam, MA
Start Date: ASAP
Employment Type: Full Time
Starting Salary Range: Competitive
Job Requisition #: 18065

 

Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. We are currently accepting resumes.

 

Job Summary:

The Director, Lab Operations acts as the primary contact for the Lab Departments including Microbiology, Analytical and Cleanroom Services with respect to new contracts, providing project outlines and contributing to pricing, in collaboration with Client Services/Account Management. In this role you will be directly responsible for managing the daily operations of the Microbiology, Analytical and Cleanroom Services departments, ensuring compliance with SOPs, policies, regulatory requirements and accreditations.

In addition, you will be the primary liaison between our clients and all laboratory operations. Responsible for applying a wide variety of scientific principles and concepts to client projects. Supervise scientific staff in the department and provide guidance with the planning and execution of scientific research and/or critical development strategies. Assign work to scientific staff and oversee the work flow, resourcing, and prioritization within the department. Provide scientific and innovative thinking with advanced level of technical skill and insight. Keep abreast and actively participate a broad knowledge of state-of-the art principles and theories both within and outside the organization.

Will be responsible for capacity planning, revenue projections and capital expenditure resourcing.

 

Job Responsibilities:

  • Manage and oversee daily laboratory operations to ensure compliance with laboratory policies and procedures.
  • Primary liaison between our clients and the operations team.
  • Supervise scientific staff in the department and provide guidance with the planning and execution of scientific research and/or critical development strategies.
  • Continuous evaluation and/or development of laboratory SOPs, test methods and policies in accordance with industry regulations and accreditations.
  • Responsible for budgeting laboratory expenses.
  • Perform and manage laboratory investigations, deviations and CAPAs.
  • Train and develop staff on test procedures and methods.
  • Provide remediation support for clients.
  • Supervise and provide career development for assigned staff.
  • Oversee compendial analyses of raw materials, finished products, and environmental monitoring samples.
  • Provide guidance on troubleshooting various laboratory tests.
  • Write and execute laboratory equipment qualification protocols Support Regulatory Inspections and Audits (i.e. FDA, EMA, MRHA, CAG, etc.)

 

Educational Requirements:

  • Bachelor’s Degree in science discipline.
  • A minimum of eight years of industry experience.
  • A minimum of five years of demonstrated leadership experience
  • Must be able to communicate effectively, both verbally and in written form.
  • Demonstrate strong computer skills in Microsoft Office including Excel, PowerPoint, and Word.
  • Demonstrated ability to work in a fast-paced environment while maintaining quality.
  • Demonstrated ability for strong attention to detail and problem-solving.
  • Demonstrated ability to make practical, realistic and timely decisions after considering facts, available resources and potential risks, and utilizing reason when dealing with sensitive topics.
  • Demonstrated ability to work both independently and in a team environment.
  • Demonstrated ability to present ideas and information in a clear, concise, organized, and diplomatic manner.

 

SUCCESS FACTORS:

  • Demonstrate the capability for continued upward growth and technical contributions.
  • Exceptional problem solving skills with the proven ability to think strategically.
  • Direct interaction with Clients and demonstrates a level of business acumen for negotiating client agreements
  • Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
  • Strong communication skills – both verbal and written.

 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.