Sr. Scientist, Bioanalytical

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Position Objective:

Demonstrate expert technical knowledge and practical experience in bioanalytical methods relating to Biologics and Gene Therapy Products. Contribute to the bioanalytical investigation of therapeutic targets and candidate molecules of disorders of the ear. Develop, design, conduct and analyze in vivo pharmacokinetic studies of drug candidates and report findings. Work includes bio-analytical methods focusing on biologics, gene therapy products using LC/MS/MS, ELISA, qPCR and other relevant assays. Manage and coordinate interactions with external CROs. Be an active member of the Research and Preclinical Development Team to generate data and reports to support new candidate assessment, IND, NDA and other regulatory filings.

Essential Functions:

Develop, design, conduct and execute bioanalytical experiments supporting the development of biologics and gene therapy products.

Support preclinical efforts by designing and conducting laboratory studies relating to bioanalytical and pharmacokinetic investigations.

Actively contribute to project and program teams and provide clear and consistent communication of ideas, data, conclusions and outcomes.

Stay abreast of the latest techniques and technical knowledge in the bioanalytical arena and share that information with the Research & Preclinical Development team. Serve as technical expert and routinely educate peers and others. Mentor the scientific staff for development of approaches, techniques and best practices.

Manage and coordinate interactions with bioanalytical CROs as needed, relating to preclinical and clinical studies.

Contribute to manuscripts for key publications (abstracts, posters, presentations) consistent with the overall scientific and medical communications plan. Present data at internal meetings and external scientific conferences and meetings. Support the development of data and other materials for patents and regulatory documentation.

Excellent analytical, research and problem solving skills required.

A commitment to high-quality research and the execution of research plans in a timely and organized manner. Excellent verbal and written communication skills as well as strong interpersonal skills, including the ability to effectively collaborate with colleagues, vendors and partners, who may have different levels of technical knowledge and understanding and to clearly convey status and progress in areas of responsibility both verbally and in writing

May train and/or mentor less experienced personnel. May perform other related duties as required and/or assigned.

Quality and Safety Responsibilities  

Must be aware of and consistently achieve required quality and regulatory compliance. In addition, this position must be aware of and follow all safety policies and instructions at all times.

Nature and Scope

Interacts on a regular basis with comparable levels of personnel in Research, CMC and Preclinical Development and occasionally with other groups including Regulatory, Clinical Development and senior management.  Requires strong communication skills with the ability to clearly convey status and progress in areas of responsibility both verbally and in writing.  Requires a strong working knowledge relevant to the applicable field.   Job encounters problems of moderate scope and complexity with variations from the norm.   The incumbent typically works independently in agreed project areas and in consultation with supervisor on new assignments and/or in areas of broader scope. Errors in work could cause delays and financial loss.

Education:

B.S. or M.S. degree in Analytical chemistry, Pharmaceutical Sciences, Drug Metabolism or related discipline is required

Experience:

Miminum of 5 years of experience in a comparable role with a biotechnology or pharmaceutical company or a combination of academia and industry required. Comprehensive knowledge of current practices in bioanalytics relating to biologics and gene therapy products. Experience with small molecules and nucleic acid based pharmaceuticals a plus. Ability to manage and execute on multiple and competing priorities is expected. Excellent verbal and written communication skills as well as strong interpersonal skills, including the ability to interact effectively with collaborators, clients, vendors and personnel, who may have different levels of technical knowledge and understanding. Ability to work as a team member are essential. Background in Otology preferred.

Working Conditions:

Works in a laboratory, facilities and/or manufacturing environment. May on a continuous basis walk, bend and lift up to 40 lbs. The noise level in the work environment is usually moderate to high.  May intermittently sit at desk for a long period of time to answer telephone and write or use a keyboard to communicate through written means.  Must be flexible to work varying schedules and hours as needed.  Occasional local travel may be required. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Employer/Females/Minorities/Veterans/Disability

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