Nicholas Hellman Email & Phone Number

Greater Chicago Area

Greater Chicago Area

Author and coordinate submission documentation for all phases of clinical development, with emphasis on later phase programs and marketing applications.

Lake Forest, Il

• Global analytical lead for multiple biosimilar candidate programs from early (pre-IND) through late (post-approval) development phases, including the Retacrit (Epoetin) biosimilar which was launched in the US in 2018• Lead the analytical development for different projects, responsible for the development, implementation, and coordination of analytical testing strategies, including lot release, stability, analytical similarity and comparability studies• Collaborate across different R&D and manufacturing functions such as cell line development, upstream and downstream process development, formulation development and pilot plant and global sites to achieve the project milestones, including clone selection, process lock, process validation and formulation lock to meet the program timelines• Directly supervise a team of three R&D scientists with responsibility for development and implementation of the analytical similarity strategy for biosimilar candidates• Manage matrix teams of scientists and technical staff across 5 internal and external sites to facility the transfer of qualified and validated analytical methods for routine release and stability testing as well as characterization testing• Author or oversee authoring for CMC sections of Investigational New Drug (IND) applications, regulatory briefing documents, and Biologics Licensing Applications (BLA) including 2 approved BLAs• Represent analytical function for assigned projects in internal Pfizer governance forums and external meetings with Health Authorities• Experience in development, qualification and validation of HPLC and UPLC methods including glycan analysis and peptide mapping to assess complex protein attributes as well as extensive experience in development and remediation of orthogonal methods to assess protein concentration with experience in method development to overcome matrix interference

Lake Forest, Il

Authoring and reviewing technical protocols and reports• Performing comparability assessments for follow-on life cycle management products using a variety of statistical approaches, including control charting, tolerance intervals, and quality ranges• Assigning product specifications for quality attributes based on statistical analysis of data, prior product knowledge and manufacturing experience• Identifying Critical Quality Attributes (CQA) for products and developing analytical control strategies for the CQAs• Developed and validated a UPLC method for quantitating the amount of trisulfide in biosimilar product to support the analytical control strategy• Developed and qualified a novel spectrophotometric-based absorbance method for measuring the protein concentration of a drug substance and prepared the method for validation

Lake Forest

• Authoring and reviewing technical protocols and reports• Performing comparability assessments for follow-on life cycle management products using a variety of statistical approaches, including control charting, tolerance intervals, and quality ranges• Assigning product specifications for quality attributes based on statistical analysis of data, prior product knowledge and manufacturing experience• Identifying Critical Quality Attributes (CQA) for products and developing analytical control strategies for the CQAs• Developed and validated a UPLC method for quantitating the amount of trisulfide in biosimilar product to support the analytical control strategy• Developed and qualified a novel spectrophotometric-based absorbance method for measuring the protein concentration of a drug substance and prepared the method for validation

Lake Forest

• Implemented new technologies in the lab, including surface plasmon resonance and Tecan liquid handling• Developed mammalian cell line expression systems and selected high-producing clones to support upstream process development• Collaborated with a CRO to develop and validate an ELISA method for quantitating host cell protein• Developed and qualified solid-phase receptor binding assays, SPR-based assays and cell-based proliferation assays • Trained and managed an intern in developing bioassays and performing routine testing• Collaborated with a CRO to develop and validate an ELISA method for quantitating host cell protein

Master Of Science (M.S.), Biology

Bachelor Of Science (B.S.), Kinesiology And Exercise Science