LabTemps is looking for a remote Senior Consultant of Analytical Services to work with our client out of their home office with 50% travel. 

Essential functions: 

• Manages multiple analytical projects related to the development, qualification and/or troubleshooting of sensitive, efficient, and reliable assays for a wide class of biological molecules simultaneously.
• Prepares, reviews, and edits method transfer, qualification, and validation protocols, analytical technical reports, and CMC regulatory documentation. 
• Writes regulatory documentation.
• Provides technical expertise and advises project representatives/teams on topics pertaining to biopharmaceutical analysis and CMC development, including assay development and selection, structure-activity relationships, product characterization strategy, impurity identification, Quality-by-Design, product quality attribute classification, and study design. Often presents findings and/or results to client senior management.
• Communicates effectively in a timely manner with external and internal clients regarding technical, scientific, and other project-related issues and progress.
• Provides technical guidance to others in resolving challenging issues relating to analytical methods
• Supports our clients marketing efforts by actively seeking new clients and repeat business opportunities.
• Keeps current with technical developments in the industry and regulatory agency thinking.
• Types of Projects: Recombinant proteins, peptides, oligonucleotides, Gene and Cell Therapies

Knowledge/Skills/Abilities:

• Thorough understanding of analytical technology, method development, method qualification/validation, and global regulatory analytical requirements.
• Laboratory experience performing method development, qualification, and validation activities.
• REQUIRED: experience working with large molecules, drug development through phase four and writing sections of BLA, and recent hands-on experience in HPLC and chromatography
• Experience with bioassay and potency assays a plus.
• Regulatory experience preferred,
• Proven ability to successfully work in a team environment.
• Excellent oral and written communication skills.
• Ability to make independent decisions.
• Willingness to travel (50%)
• Biotech therapeutic experience is REQUIRED
• Pharmaceutical manufacturing experience is REQUIRED
• Method qualification/validation experience is REQUIRED
• Regulatory writing experience is REQUIRED

Education/Experience:

• PhD in Analytical Chemistry, Biochemistry, or related discipline, with 4+ years of relevant experience

Competencies:

• Self-motivated 
• Shows initiative
• Results-oriented              
• Creative thinker
• Detail-oriented
• Focused on continuous development

• Medical, Dental, Vision, Life Insurance
• 401K