Skip to Main Content
← Back to Jobs

Sr Consultant, Biotech Analytical Services-Work from home & 50% travel

Messina Group Chicago, IL
  • Expired: over a month ago. Applications are no longer accepted.

Our Client is looking for a remote Senior Consultant, Biotech Analytical Services to work out of their home office with 50% travel. This is a direct hire, permanent position.

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


JOB REQUIREMENTS
Competencies (soft skills, traits, behaviors):

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


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 in Biotech (large molecule) and writing sections of BLA
  • Analytical Drug Development Experience for a pharmaceutical company or FDA
  • 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%)


Education/Experience:

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

Messina Group

Why Work Here?

Great opportunity with a growing company!

Messina Group is a national Staffing and Consulting solutions firm that has grown to over 200 employees and continues to serve its clients across numerous industries. With an average employee tenure of 15 years, Messina understands the level of quality talent organizations need to succeed. Messina Group encompasses two national divisions: Messina Group Staffing and Messina Group Consulting. Combined, these two divisions provide customers a full suite of People, Process and Technology initiatives through professional staffing offerings and consulting services. As a trusted advisor to its clients, the experience and longevity of Messina Group’s staffing division provides both stability and a competitive advantage to clients and their business. Our staffing expertise includes: • BECO | Manufacturing & Engineering Staffing • BECO | Architectural & Engineering Staffing • LabTemps | Scientific & Laboratory Staffing • FinancialTemps | Financial, Accounting & Administrative Staffing • MG | Project Management & Information Technology Staffing • MG | Digital Marketing & Creative Staffing

Address

Chicago, IL
USA

Website