A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
As a Scientist/ GLP Study Director your activities will support safety testing required to manufacture clinical and commercial products. Acting as a Study Director, you will be responsible for GLP study design and oversight and scientific integrity of the technical work conducted and associated documentation, data interpretation, and reporting of study results. Requirements also include maintaining a thorough understanding of company testing services, technical principles and applications as they apply to your position.
ESSENTIAL JOB FUNCTIONS:
Who you are:Minimum Qualifications:
- Independently designs studies and oversees testing in accordance with SOPs and GLP regulations
- Acts as subject matter expert (SME) and maintains a working knowledge of viral clearance procedures and assays
- Maintains complete and comprehensive records for study integrity and performs data analysis
- Utilizes problem solving/trouble shooting skills in real-time
- Utilizes applicable computer programs during routine administration of tasks (i.e. Word, Excel, LIMS, TrackWise, etc.)
- Liaise with Quality Assurance, Project Management, and appropriate cross-functional departmental areas to investigate deviations, communicate study progress, and relay preliminary results to clients
- Creates/revises SOPs, laboratory records and other related documentation, as assigned
- Performs training of laboratory personnel as needed/assigned
- Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment
- Acts as key driver/ champion on project teams
- Complies with company health and safety regulations and procedures
- Performs other duties as assigned
- Ph.D. in scientific discipline with 1+ years' experience
- MA/MS in scientific discipline with 3+ years' experience
- BA/BS in scientific discipline with 5+ years' experience
What we offer:
- Intermediate skills in applicable computer programs
- Experience in GLP or GMP environment
- Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.
- Excellent time management skills
- Highly collaborative, but able to work independently
- Demonstrates a high level of initiative and leadership capabilities
- Effective coaching and training skills for complex and highly technical work
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance
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.
As an employee of the Company, you will be required to comply with all of the Company's COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.