RampD Sr. Scientist

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We are seeking a R&D Sr. Scientist for a very important client.

PURPOSE AND SCOPE:
Sr. Scientist must be the key knowledge resource and key technical expert on products and projects that support company?s goals. The Sr. Scientist is largely unsupervised and self-motivated to lead projects. The Sr. Scientist is capable of being given a high-level task and works independently and collaboratively to solve complex and wide-ranging problems as well as address company-wide concerns. The Sr. Scientist is able to execute a full new research project, from conception to formulating pre-development and working on feasibility studies. The Sr. Scientist, as the technical expert, has the ability to provide technical seminars across all areas of the company.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
? Designs studies to evaluate new and existing analytical methods and instrumentation.
? Assess, select, and design components based on analytical chemistry, biochemistry, and material science techniques.
? Champion scientific and analytical rigor in method development and validation throughout entire business.
? Identifies alternative procedures to solve problems.
? Reviews publications, articles and abstracts to stay abreast of technical industry.
? Participates in cross-functional teams.
? Plans, coordinates, direct tracks, and executes well-defined, short-term and long-term R&D project(s). If necessary, supervise technical personnel.
? Disclose findings to cross-functional teams and senior management through captivating and compelling presentations.
? Propagate culture of rigorous mathematics, fundamental science, and sound science and engineering in all work.
? Foster culture of collaboration, knowledge transfer, and continuous learning at all times.
? Assures compliance to corporate policies, standard operating procedures, domestic and international standards.
? Collaborates with suppliers to determine optimum specifications for company products.
? Collaborates with teams to transfer technologies to manufacturing for commercialization.
? Develops & revises Standard Operating Procedures (SOPs) and working practices.
? Develops a working understanding of FDA Design Control Concepts.
? Develops scientific technology platforms for company products.
? Hands-on involvement with experiments in laboratory
? Interacts with outside consultants on project related technical matters, as needed.
? Maintains documentation practices for all data forms, protocols, reports, Design History files, laboratory notebooks, and other documentation sources.
? Maintains general housekeeping of working area and plant.
? Mentor other staff as applicable.
? Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
? Self-motivated to improve knowledge related to research projects by continuous assessment of current publications. Keeps up-to-date with scientific technology in fields relating to company products.
? Understands the theory behind instrumentation and function of company products, and develop new techniques and test methods.
? Other duties as assigned.
Requirement:
The ideal candidate will possess the following qualifications:

EXPERIENCE AND REQUIRED SKILLS:
? 5 ? 8 years related experience;
? Master?s degree with ?3 years related experience;
? PhD or equivalent, without experience or directly related work experience
? Must have extensive experience in the following analytical techniques: HPLC, UPLC, LC-MS (UPLC-QQQ and UPLC-QTOF).
? Must have experience in test method development, test method validation and test method transfer.
? Experience in Atomic Spectroscopy (AAS, AES, ICP-OES, ICP-MS, etc.)
? Experience in Gas Chromatography (GC-FID, GC-MS)
? Ability to quickly learn and apply new scientific and engineering principles, and develop other skills.
? Strong mathematics, critical thinking, and data analysis capabilities.
? Strong laboratory skills with good management of laboratory documents.
? Excellent communication skills, able to speak clearly, write legibly, and accurately convey their work.
? High level of proficiency with MS Office and scientific data process software.

Extractables & Leachables (E&L) and Toxicology ? PEC.SCC
? Possesses strong background in extractables and leachables testing and toxicological risk assessments for pharmaceuticals and medical devices.
? Drives global harmonization based upon best practices for extractables and leachables testing and toxicological assessments.
? Experienced in working with internal Medical staff and external Contract Research Organizations (CROs).
? Leads the preparation and execution of extractables and leachables strategies and test plans, and toxicological risk assessments, as a member of cross-functional teams that develop new and improved medical devices and pharmaceuticals.
? Prepares and manages project budgets, schedules and resource plans for E&L and Toxicology work.
? Researches and complies with all relevant industry regulations.
? Leads the research, development and validation of new, advanced test methods, as needed.
? Prepares clear technical reports, publications and oral presentations. Delivers updates to the Engineering Project Manager (EPM), Program Project Manager (PPM) and senior level management within the context of the overall project goals, as needed.
? May create and present technical information at conferences/meetings held by professional organizations within our industry.
? Prepares inputs to relevant sections of regulatory submissions (e.g., FDA NDA), and may be called upon to address questions from the regulatory bodies.
? May provide GRD support for Sustaining Engineering projects, as agreed upon, during the product life cycle.
? Strong statistical skill set is a plus.
How to Apply:
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