Apex Systems
Associate Director/ Prin Sci, Analytical Development (Small Molecule)
Apex Systems, Cambridge, Massachusetts, us, 02140
Associate Director/ Prin Sci, Analytical Development (Small Molecule)
Associate Director, Analytical Development (Small Molecule) 2035840
Location : Cambridge, MA (Onsite)
Science:
Small Molecule Therapeutics Job Overview:
The Associate Director in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners.
Primary Job Responsibilities:
Develop specialized testing methodologies for small molecule drugs using HPLC and GC.
Oversee impurity characterization and stability studies for drug substances and products, ensuring regulatory compliance.
Manage analytical testing and development activities with external partners to keep projects on schedule.
Collaborate on CMC, quality processes and regulatory submissions, providing internal and external project alignment.
Primary Job Requirements:
PhD in Analytical Chemistry with 6+ years in CMC analytical development for small molecule Drug Substance and Drug Product.
Expertise in method development for small-molecule drugs, with broad analytical expertise including HPLC, GC, MS, and NMR techniques.
Knowledgeable in GMP/ICH guidelines and adept at managing stability studies.
Skilled in guiding CDMOs, drafting regulatory documents, and leading cross-functional project teams.
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
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Small Molecule Therapeutics Job Overview:
The Associate Director in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners.
Primary Job Responsibilities:
Develop specialized testing methodologies for small molecule drugs using HPLC and GC.
Oversee impurity characterization and stability studies for drug substances and products, ensuring regulatory compliance.
Manage analytical testing and development activities with external partners to keep projects on schedule.
Collaborate on CMC, quality processes and regulatory submissions, providing internal and external project alignment.
Primary Job Requirements:
PhD in Analytical Chemistry with 6+ years in CMC analytical development for small molecule Drug Substance and Drug Product.
Expertise in method development for small-molecule drugs, with broad analytical expertise including HPLC, GC, MS, and NMR techniques.
Knowledgeable in GMP/ICH guidelines and adept at managing stability studies.
Skilled in guiding CDMOs, drafting regulatory documents, and leading cross-functional project teams.
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
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