Senior Consultant, Analytical Services
BioTechLogic, Inc.
Remote
Job details
$120,000 - $180,000 a year
Full time
Benefits
Disability insuranceHealth insuranceDental insurance401(k)401(k) matching
Job description

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 CMC regulatory documentation for analytical methods.
  • 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 BioTechLogic’s marketing efforts by participating in new client pitches and actively seeking 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 a wide spectrum of analytical technologies, method development, method qualification/validation, and global regulatory analytical requirements
  • Laboratory experience performing method development, transfer, qualification, and validation activities
  • Experience with multiple compendial methods such as pH, endotoxin, and UV assays
  • Experience with chromatographic assays
  • Experience with bioassay and/or 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 (up to 50% once deemed safe to travel again)

Education/Experience:

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

Job Type: Full-time

Pay: $120,000.00 - $180,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Disability insurance
  • Health insurance
  • Paid time off

Schedule:

  • Monday to Friday

Supplemental Pay:

  • Bonus pay

Education:

  • Master's (Required)

Experience:

  • Laboratory Experience: 4 years (Required)

Willingness to travel:

  • 50% (Preferred)

Work Location:

  • Fully Remote

Company's website:

  • www.biotechlogic.com

Work Remotely:

  • Yes

COVID-19 Precaution(s):

  • Remote interview process
  • Virtual meetings

Work Location: Remote

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Company details

Headquarters

Glenview

Employee

2 to 10

Revenue

less than $1M (USD)

Industry

Pharmaceuticals

Company Description
BioTechLogic, Inc. provides biopharmaceutical regulatory and manufacturing consulting services with strategic and hands-on experience to assist clients in bringing their products to market quickly and successfully by augmenting and optimizing their organization’s resources. We are a team of professionals with expertise in Process Development, Manufacturing, Process Validation, Analytical Testing/Quality Control, Quality Assurance, Writing/Reviewing Regulatory Submissions, Project Management, Supply Chain Management and Combination Products.
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