This position will interact with multiple levels of the organization. Candidate must have the ability to approach issues from both a strategic and tactical perspective. Additionally, the successful candidate must demonstrate business acumen, communication/presentation skills, and the ability to influence others. This includes the ability to effectively drive both internal and external (in partnership with contract development/manufacturing organizations) team discussions, through active engagement of multiple client relationships supporting various components of the product supply chain.
Job Duties include:
• Conduct and partner with vendors to support the analytical and bioanalytical needs of clinical development projects; managing timelines and workflows effectively.
• Provide scientific insight into biologics characterization
• Development of regulatory documents / Module 3 analytical content in collaboration with Regulatory Affairs CMC, serving as the analytical lead for associated regulatory interactions. Respond to analytical questions from regulatory agencies.
• Conduct and coordinate drug substance / API characterization, drug product characterization, and in-vitro testing as needed.
• Participate in bioanalytical activities including managing the development, qualification, and validation of methods.
• Drive innovative approaches to the development, evaluation, and negotiation with regulatory agencies of analytical control strategies including specifications and stability.
• Establishment and management of associated reference standards and reference materials.
• Adopting and driving innovative analytical techniques and strategies that translate into robust commercial analytical testing platforms.
• Perform other analytical duties as assigned
• Ph.D. in (bio)chemistry or related field
• Minimum of 8 years of progressive experience in analytical sciences within the biopharmaceutical industry
• Strong understanding of drug development process and related regulations; including cGMP requirements
• Strong knowledge of biologics characterization techniques
• Experience with HPLC, Immunological, and MS techniques
• Experience with stability and comparability studies
• Experience with procedures leading to US and international regulatory approvals
• Organized and detail-oriented
• Excellent communication and presentation abilities
• Proficiency with MS Office suite
• Ability to travel up to 20% as needed
• Broad experience leading Analytical Development activities with GMP responsibilities
• Demonstration of driving analytical innovation
• Experience working with or for a Contract Manufacturing Organization (CMO)
• Previous experience leading project teams or managing direct reports