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