Job#: 2035840
Job Description:
Associate Director, Analytical Development (Small Molecule) 2035840Location: Cambridge, MA (Onsite)Science:Small Molecule TherapeuticsJob 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
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT
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. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.
