Azurity Pharmaceuticals
Pharmaceuticals
Manager,TechnicalOperations
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager, Technical Operations at Azurity Pharmaceuticals. Skills: Analytical method development, Method validation, Technical transfers, GMP compliance. Develop analytical methods for product development. Conduct forced degradation studies”
What You'll Achieve.
Achieve project milestones
Industry & Context.
Deviation investigation; OOS investigation; Address regulatory queries
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, Minimum 8 years of experience in biopharmaceutical/pharmaceutical GMP environment, Thorough knowledge of cGMPs, ICH, USP, In-depth experience in performing analytical / microbial method transfers, Proficient in Microsoft Word, Proficient in Microsoft Excel, Proficient in Microsoft Powerpoint, Experienced in participating in regulatory agency inspections
Nice to Have
Master's Degree preferred
What You'll Do.
Develop analytical methods for product development
Conduct forced degradation studies
Identify unknown impurities
Perform experiments to address regulatory queries
Qualify and maintain working and reference standards
Verify analytical methods
Execute analytical ATR
Share findings with formulation team
Conduct literature reviews
Follow good documentation practices
Prepare technical reports
Prepare method development reports
Prepare verification reports
Support method validation
Support method transfer
Support method verification
Review excipient methods
Review vendor methods
Apply pharmacopeial information
Comply with data integrity requirements
Comply with regulatory expectations
Initiate change controls
Investigate deviations
Calibrate HPLC systems
Calibrate dissolution apparatus
Calibrate KF apparatus
Prepare specifications
Archive lab notebooks
Maintain lab cleanliness
Maintain safety standards
Ensure documents are adequate
Ensure data are adequate
Ensure documents are accurate
Ensure data are accurate
Ensure documents are complete
Ensure data are complete
Procure project materials
Dispose of leftover samples
Dispose of expired chemicals
Dispose of expired reagents
Receive samples from CROs
Receive samples from CTOs
Receive samples from CMOs
Send materials to CROs
Send materials to CTOs
Send materials to CMOs
Receive materials from CROs
Receive materials from CTOs
Receive materials from CMOs
How You'll Work.
Team & Collaboration
Collaborate cross-functionally
Communication Scope
Share findings
Process & Methodology
Project milestones
Full Job Description
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief team/department description: Technical Operations is responsible for management and oversight of technical process strategy, CDMO management, and execution of product deliverables in alignment with Azurity policies and objectives. The position leads staff and contractors and collaborates cross-functionally to achieve project milestones in support of process analytical method developments, analytical method validations, analytical method verifications and validations, method verification of excipients, packaging materials, scale-ups and process validation, technical transfers, implementation of lifecycle post approval changes, and investigation / closure of deviations / OOS for commercial products. This position ensures the post registration development activities, tech transfers, validation / launch and product post approval change projects are driven to success across CDMO network. This role is responsible fo
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