Director of Study Management, Toxicology

Posted 01 Oct 2019

Rockville, Maryland - United States

Req Id 198049

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role:

The Director is the lead scientific resource for Genetic Toxicology within MilliporeSigma (BioReliance Toxicology Testing Services).  Provides leadership and direction to the Genetic Toxicology staff.  The Director has responsibility for hiring, performance assessment, training, and professional development of the study director staff.  Serves as Test Facility Management for Toxicology.  Provides and executes Genetic Toxicology testing strategies for the clients.  The Director also introduces new product lines by guiding and directing the scientific research programs of the Service Development committee. 

 

  • Act as a Champion on initiatives and/or projects to drive improvement in quality and/or client service.
  • Develop consistency across the team in terms of general approach – use process mapping to help drive this.
  • Assign GLP and non-GLP Study Directors the studies to be performed for Toxicology Testing Services
  • Assure compliance with quality and regulatory requirements in the documentation of laboratory studies and assure assays are performed error-free by tracking, monitoring, and implementing improvement activities to achieve Right First-Time goals.
  • Analyze internal and/or external delays in order to identify trends and implements improvements to achieve OTD and TAT goals.  Exceed Customer Expectations for turn-around time (TAT) of studies as measured by on-time delivery (OTD) percentage. 
  • Adheres to ISO / IEC 17025:2005 standard for laboratory testing as specified in applicable standard operating procedures.
  • Participate in regulatory agency audits and address observations by implementing corrective and preventative actions when required.
  • Achieve revenue and EBITDA objectives by forecasting capacity requirements, preparing annual capital and expense budgets, analyzing variances, and initiating corrective actions.
  • Evaluate processes and information systems for scalability to accommodate unpredictable surges in demand and planned growth and promote a culture of continuous improvement both internally and externally.
  • Track and trend key assay parameters and implement courses of action to address any adverse trends and/or issues that arise.
     

Who You Are:

Minimum Qualifications:

  • Ph.D. in Biology, Chemistry, Biochemistry, or related discipline.
  • 5+ years’ experience at a CRO or other commercial setting experience.
  • 5+ years of personnel management experience.
  • Working knowledge of laboratory methods and practices in a GLP setting.
  • Ability to monitor trends and implement corrective actions.
  • Working knowledge and understanding of Toxicology.

 

Preferred Qualifications:

  • Working knowledge and understanding of Genetic Toxicology.
  • Strong organizational skills.
  • Strong written and verbal communication skills.
  • Detail oriented work approach.
  • Ability to solve problems.
  • Future-thinking oriented.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com


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.

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