Compliance Specialist, Analytical Development

Pay Rate Range: $45-55/hr depending on experience

Duties

JOB SUMMARY:

We are seeking a Compliance Specialist to contribute to our growing Analytical Development team. The Compliance Specialist will participate in all aspects of compliance and development management in Analytical Development, working closely with cross-functional teams to onboard instruments/equipment, performing data/document/record review, and authoring various compliance documents.

This position may also require hands-on laboratory experience from time-to-time working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for company projects.

This is an on-site, technical laboratory-based position that involves development, validation, and execution of analytical methods for testing of biologics. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support and compliance management.

Job Responsibilities

• Work closely with the CMC team to manage and coordinate analytical activities
• Manage early and/or late phase drug substance and drug product analytical activities at contract testing laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
• Execute technical analytical methodologies to support development and validation of test methods.
• Author and review raw data (e.g. stability data packages and ad hoc testing), analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
• Assist in authoring and reviewing various regulatory submission and interaction documents
• Assist in the developing, authoring, and/or reviewing standard operating procedures
• Manage reference materials and reference standards inventory and (re)qualification testing
• Manage vendor maintenance and calibration for AD-owned equipment, instruments, and systems
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.
  
  

Skills

• Experience in drafting protocols, methods, reports, and/or procedures.
• Experience in performing change control, deviation, laboratory investigation, and/or other quality records.
• Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics; R, Python, or other statistical tools preferred.
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.
  
  

Preferred Qualifications

• Demonstrated experience in managing outsourced analytical activities
• Demonstrated experience in QC data review of release and stability data packages
• Experience in Liquid Chromatography and/or Immunoassays is highly desired.
  
  

Education

• Bachelor’s degree in biological sciences or related field with 4 years of progressive experience in the biotechnology or pharmaceutical industry.
• 3 years of experience in a regulated/GMP environment.
• 2 years of experience in a quality function (QC or QA organization)