Merck Millipore plays an integral part in the life science community, harnessing our passion and innovation to help researchers and drug producers around the world. As science advances, we advance with it, offering new insight and cutting-edge technologies helping our customers solve the world’s most challenging human health issues.
Our promise to our customers is that we’ll be there every step of the way. If you share our goals and values, and want to make your mark at a rapidly growing international company, join us and help advance the future of life science together. Merck Millipore is a division of Merck KGaA. Merck is a global pharmaceutical and chemical company with a history that began in 1668, and a future shaped by around 40,000 employees in 64 countries around the world.
Currently, we are seeking a Principal Scientific Director at our Oxford facility for our Drug Discovery Services division.
This is a 6 month contract position.
The principal purpose of position is:
- To be responsible for overall the scientific development of client studies, ensuring that scientific integrity is achieved.
- To provide guidance and support for the relevant regulatory needs, providing guidance and mentorship to help ensure data and work is done in a quality and regulatory compliant manner to achieve clients requirements
- To provide scientific consultation for clients during business development process and ongoing project assignments. In particular be involved in proposal preparation and presentation to new clients and projects for new services.
- To serve as scientific and technical advisor for clients and internal teams for development, validation, and application of assays to comply with scientific and technical goals and regulatory requirements Additionally this role is responsible for business development, defining strategic and tactical approaches to bring on new service lines, to develop scientific programs to drive new and existing client projects, to serve as technical owners and scientific leaders on new technologies, strategic opportunities and business development
- Overall approximately 50% of the time will be spend on internal processes and insuring quality and consultation and 50% will be spent on an outward focus of developing new clients, moving clients to a higher tier of service and providing strategic, technological and focus on new growth opportunities.
Responsibilities:
- Develop client scientific and regulatory relationships (existing and new)
- To provide guidance and oversight for compliance and scientific integrity of the studies to ensure that studies are performed in a compliant manner
- To define scope of work, focus of the project and consultation to the client
- To define the appropriate technical approach to accomplish the clients requirements
- Provide Program Managers with scope of the work, estimates of time required to complete the project, level of technical challenges for expectation setting and scientific input for use in proposal preparation.
- To present proposal to clients for new clients and new services and address any concerns from the client
- Propose the expertise needed for the Study Directors, Principal Investigators (GLP) or Scientific Director (GCP and GMP) and Lead Scientists (for assay development studies) for each client study based on the client requirements and experience with the client
- Serve as Study Director, Principal Investigator or Scientific Director or Lead Scientist as needed
- Accountable for sign off of validation plans as proposed by the validation team.
- Accountable for sign off of validation reports as provided by the validation team. Oversee the following as provided by the Operations team
Knowledge, Skills & Experience
- A PhD or Masters degree in a biological science, or equivalent experience.
- At least 5 years relevant experience in pharmaceutical industry and/or CRO or similar
- Demonstrated success in client interaction, proposal development and sound project plans, presentation to clients at VP and higher levels and develop client relationships
- Demonstrated experience in working effectively with business development, sales and customer service organizations
- A working understanding of international regulatory requirements including MHRA and FDA GMP, GCP and GLP and a proven mechanism to stay relevant on such requirements
- Appropriate technical experience of relevant laboratory techniques
- Excellent interpersonal, verbal and written skills, including ability to prepare detailed scientific reports and group presentations
- Demonstrated ability to work independently and without instruction
- Experience in managing and leading cross functional teams effectively
Desirable
- Experience within the Company or a similar contract laboratory
- Business development experience within the industry
- Key membership experience within industry organizations
- Experimental Design for method development
- Analytical Procedures
- Study Plans
- Sample Analysis Reports
- Deviation Reports
Merck Millipore values your talents
Merck Millipore offers an attractive international working environment, valuing your talents and training you to develop new skills. We believe in building a strong relationship with our employees.
Please apply via the Merck Careers website using requisition number: 1202295