Centessa Pharmaceuticals
Biotech
AssociateDirector,AnalyticalDevelopment
Neural analysis suggests this role is
optimal for Director candidates.
“Associate Director, Analytical Development at Centessa Pharmaceuticals. Skills: Analytical Development, Small Molecule Development, Regulatory Submissions. Review and assemble information for analytical sections in. Coordinate domestic shipments”
Industry & Context.
Analytical investigations; Troubleshooting
Occasional travel
What They're Looking For.
Must Have
PhD in Chemistry, PhD in Pharmaceutical Sciences, MS with extensive relevant biotech/pharmaceutical industry experience, 10+ years of experience in biotech/pharmaceutical industry, Small molecules experience, Early to late-development experience, Analytical planning experience, Resource management skills, In depth knowledge of assay development, In depth knowledge of related substances development, In depth knowledge of forced degradation, In depth knowledge of HPLC/UPLC, In depth knowledge of GC, In depth knowledge of KF, In depth knowledge of XRPD, In depth knowledge of residual solvents, In depth knowledge of elemental impurities, In depth knowledge of microbial testing, In depth knowledge of dissolution, In depth knowledge of compendial methods, Hands-on experience carrying out stability studies, Knowledge of ICH stability guidelines, Knowledge of compendial requirements, Knowledge of compendial standards, Detailed knowledge of current Good Manufacturing Practices (cGMP), Ability to identify/remediate gaps in processes or systems
Nice to Have
Experience managing DS/DP stability, Experience in QC settings
What You'll Do.
Review and assemble information for analytical sections in
Coordinate domestic shipments
Coordinate international shipments
Serve as a technical expert
Aid in analytical investigations
Aid in troubleshooting
Assist with batch record review
Assist with deviation investigations
How You'll Work.
Team & Collaboration
Internal business partners; External business partners; Managing groups; Managing CMOs; Managing CDMOs; Managing vendors
Communication Scope
Interpersonal skills; Communication skills
Process & Methodology
Agile
Full Job Description
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R review and assemble information for analytical sections in regulatory submission documents (e. g. IND, IMPD, NDA, etc) Coordinate and execute domestic and international shipments Serve as a technical expert and aid in analytical investigations and troubleshooting Assist with batch record review and deviation investigations Qualifications PhD in Chemistry, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant biotech/pharmaceutical industry experience 10+ years of experience in biotech/pharmaceutical industry in small molecules, working in early to late-development (pre-clinical to phase 3) Strong analytical planning and resource management skills in a dynamic environment located across multiple geographies In depth knowledge of assay and related substances development, forced degradation, HPLC/UPLC, GC, KF, XRPD, residual solvents, elemental impurities, microbial testing, dissolution, compendial methods. Hands-on experience in carrying out stability studies for drug substance and drug product in development and/or QC settings Experience managing DS/DP stability, and knowledge of ICH stability guidelines Knowledge of compendial (USP, EP, etc) requirements and standards Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems Strong organizational skills and attention to detail Good interpersonal and communication skills to collaborate effectively with internal and external business partners Requires a good understanding of managing groups, CMOs, CDMOs and other vendors Work Location The Associate Director, Analytical Development role is based in the US, with occasional travel. Compensation The annual base salary range for this position is $180,000.00 to $195,000.00. Individual compensation within this range will be determined
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