Brian Kirk
CMC Regulatory Affairs | PhD, Chemistry & Chemical Biology | AdvDip, Bioengineering | Regulatory Affairs Certificate: Pharmaceuticals | Panelist for Data-Driven CMC webinar, hosted by Bioprocess Online Live
- Role
- Consultant, Regulatory Cmc Technical Writer at Black Diamond Networks
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Brian Kirk
Experienced in…
Experience
Consultant, Regulatory Cmc Technical Writer
Jun 2025 — Present
Supporting the pharmaceutical division of a well-known multinational conglomerate client through the application of CMC regulatory strategy, authoring of regulatory dossiers and CMC technical documents (i.e. tech transfer, process optimization, analytical method feasibility, etc.) throughout the product lifecycle. The client\'s portfolio of small molecules and biologics is focused on the treatment of various forms of cancer.
Skills
- Technology Transfer
- Quality Auditing
- Pharmacology
- Medicinal Chemistry
- Drug Development
- Quality Assurance
- Lead Change
- Quality Control
- Drug Discovery
- Analytical Method Validation
- Sop
- Hplc
- Clinical Development
- Drug Design
- Adme
- Chemistry
- Ind
- Gmp
- Pharmaceutical Industry
- Cmc
- Organic Chemistry
- Biotechnology
- Lc-Ms
- Organic Synthesis
- CRO
- Assay Development
- Standard Operating Procedure (Sop)
- Gxp
- Lims
- High-Performance Liquid Chromatography (Hplc)
- Good Laboratory Practice (Glp)
- Quality System
- Glp
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