Scientific Development Professional Job in Saint Charles 63304, Missouri US
EMD Millipore is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world's challenging human health issues. From research to development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. EMD Millipore is a division of Merck KGaA, Germany. Merck KGaA 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.
We are currently seeking a:
Scientific Development Professional.
Purpose of the Job:
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 and product 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, business development and DDS Roadmap development. Overall approximately 50% of the time will be spent 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.
Tasks and Responsibilities:
- Develop client 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 manage the client interaction and to define SOW, 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 principal investigators and lead scientists for each client study based on the client requirements and experience with the client.
- Serve as principal investigator as needed (but in most cases this will be a manager, supervisor or validation scientist).
- Accountable for sign off of validation plans as proposed by the validation team or Operations manager.
- Accountable for sign off of validation reports as provided by the validation team or Operations manager
- Oversee the following as provided by the Operations team
- Experimental Design for method development
- Test Methods
- Study Plans
- Sample Analysis Reports
- Deviation Reports
- Review as needed study memos, study plan amendments and other documentation
- Be informed of all OOS findings and participate in the determination of root causes and resolutions
- Attend management, operations, quality systems, and other internal meetings as required
- Manage all key client meetings (on-site, off-site, phone calls etc) – is dependent upon Program Managers to get Scientific Development involved (early on as problems begin to arise)
- To participate in internal, Sponsor and regulatory audits
- To provide scientific and regulatory input to business development activities and client relationships and new business opportunities
- Provide high level scientific consultation for clients during sales process and ongoing project assignments.
- Serve as scientific and technical advisor to scientists and technicians for the development, validation, and application of assays
- Promote Millipore DDS by serving as a leadership role in external professional organizations to include conference attendance/participation, involvement in writing white papers, and speaking engagements.
- To assist or consult in validation of software and qualification of equipment as required
- Participate in reporting major quality incidents to Program manager for Client communication
- Regularly review with QA deviation and OOS logs as well as other quality findings
- To attend and/or lead internal and external training courses in line with business need
- To write and review company SOPs as required
- To perform other duties as required by Company management
Qualifications and experience:
Essential
- A PhD or Masters degree in a biological science, or equivalent experience.
- At least 10 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 and GLP and a proven mechanism to stay relevent 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
