Bioanalytical Project Manager Jobs in Edison, NJ

Senior Scientist I is responsible to carry on advanced metabolite identification and elucidation, report writing in the metabolism-biotransformation function. Deliver high quality data in a timely fashion to support discovery, IND and late stage of development work. Able to perform complex trouble-shooting and problem-solving in the metabolism areas. Have the ability to implement new technologies and processes. Coordinate and work with other functions to deliver outstanding outcomes for assays/studies/projects in the field of drug discovery and development.

• Perform the identification of drug metabolites by using liquid chromatography-tandem high-resolution accurate mass spectrometry, NMR, and other analytical methodologies independently.
• Independently elucidate metabolic pathways involving the identification and quantification of metabolites in biological matrices (e.g., blood, plasma, excreta) by using HPLC with radioactivity detection and LC-MS/MS.
• Design and conduct complicated in vivo and in vitro metabolism studies. Provides multiple approaches during the planning step.
• Familiar with modern LCMS and other analytical techniques for metabolite separation and identification and familiar with specialized metabolic profiling software.
• Work on complex problems in which assays of situations or data require an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results
• Handle radio-labeled materials (e.g., 3H, 14C).
• Function as a study director, principal investigator, or project manager including serving as a primary contact for projects, responsibilities include planning, conducting and delivering projects in high quality and time fashion
• Familiar with regulatory guidance such as MIST guidance and acceptance criteria for discovery, IND and NDA stages of application.
• Maintain research notebooks in a well-organized manner.  All necessary documentation is recorded.
• Review other scientists’ calculations, records, and reports.
• Train, coach or mentor others on technical, personal development or business issues. Demonstrate good leadership through leading by example, motivation, and performance recognition.
• Write comprehensive reports, recommending application of findings, and present clear and concise oral reports of processes and accomplishments.
• Learn, enhance, and share technical knowledge of DMPK including ADME, PK, Metabolism, and Bioanalysis.
• Participate in writing and reviewing Standard Operating Procedures (SOPs), metabolism assay acceptance criteria and suggest practical changes. Comply with SOPs, guidelines and good housekeeping policies.
• Follow and promote company’s policies including safety policies, practices and procedures in order to maintain a safe work environment.
• Other duties as assigned.

• PhD, Master or bachelor’s degree in chemistry, Biology, or related science degree. PhD with 3+ years related experience.  Master’s degree with 10+ years related experience, Bachelor’s degree with 13+ years related experience or equivalent combination of education and/or work experience. 

Knowledge / Skills / Abilities:

• Strong knowledge and experience of experimental methods, concepts and techniques relevant to metabolite identification and profiling, such as in vivo/in vitro sample processing, method development and analysis, structure elucidation and metabolic pathways.
• Strong background in organic and analytical chemistry and extensive experience of interpreting complex mass spectrometry data.
• Familiarity with specialized metabolic profiling software.
• A good understanding of regulatory guidance like MIST guidance and acceptance criteria in discovery and development stages.
• Emerging skills in novel experimental methods, concepts and techniques
• Demonstrate independent thought and scientific creativity
• Demonstrate technical success and proficiency in projects
• Can independently propose and conduct research and develop new methodologies to implement and resolve complex problems
• Effective oral and written communication and interpersonal skills
• Good time management skills to perform multiple projects within timelines
• Ability to work in a team environment
• Follow and adhere to non-GLP guidelines/SOPs consistent with WuXi AppTec requirement

Physical Requirements: 

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with exposure to biohazards / chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to push/pull/lLift 15 lbs. routinely
• Ability to crouch, bend, twist, and reach
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to work in variable temperatures high to freezing

Anticipated salary range: $100,000 to $115,000

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.