NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Melissa Kirkegaard

Practice Area Focus

  • Biologics
  • Biosimilars
  • Drugs
  • CMC

Biography

Melissa Kirkegaard joined NDA Partners as an Expert Consultant in 2017. Ms. Kirkegaard has more than twenty-five years of experience developing successful biological and pharmaceutical products at both start-up and established biopharma companies.

As Associate Director of Product Development R&D at Allergan, she was a CMC Analytical lead for multiple clinical products. She was responsible for developing analytical and stability regulatory strategies, writing CMC sections of INDs and overseeing testing at contract testing labs. She also assisted with establishing quality agreements and performing quality audits for the global auditing team of contract testing labs using the global compliance auditing process. In her role as Associate Director of Analytical and Quality Control at Kythera Biopharmaceuticals, she was responsible for providing quality and compliance oversight of supplier quality systems through supplier assessments, audits, quality agreements, review/approval of investigations, change controls, and technical documentation. She has developed and delivered GMP and GLP training, performed audits of contract manufacturing organizations, and managed good laboratory practices (GLP) implementation. In her early career, she was a Stability Project Manager in Corporate Quality at Amgen.

Ms. Kirkegaard’s experience encompasses identification, implementation, and management of CMC activities for biologics, small molecules, and combination device products from preclinical through commercial, as well as writing and/or reviewing associated regulatory filings and providing oversight and management of contract manufacturers.