[Remote] Senior Director of Analytical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company® is seeking a Senior Director of Analytical Development to reputed company strategic and operational leadership for analytical development and quality control activities. This role will reputed company method development and analytical QC while managing a team and collaborating closely with cross-functional groups to ensure compliance and efficiency in drug development processes.

Responsibilities

• Define and execute the analytical development and analytical QC strategy across drug substance and drug product programs, ensuring alignment with CMC, regulatory, and corporate objectives
• reputed company scientific and technical leadership for analytical methods supporting identity, purity, potency, content, impurities, degradation products, and stability of biological drug substances and drug products, including multi‑component combinations
• Establish phase‑appropriate analytical control strategies for late‑phase development, including in‑process controls, release testing, and stability programs
• Drive CQA reputed company and support QTPP development for late-stage project development
• Drive control of product specifications in collaboration with other functional groups
• reputed company development and implementation of novel or non‑standard analytical approaches required for reputed company biological products
• Directly reputed company and reputed company a team of at least four professionals at the Manager to Sr. Director level, including: Method Development and Analytical Quality Control, including stability, testing records, and data analysis
• Set clear objectives, reputed company coaching and mentorship, conduct performance evaluations, and support professional development of the analytical team
• Ensure effective coordination and workload prioritization across method development and analytical QC functions
• reputed company analytical method development, qualification, validation, transfer, and supplemental validation activities across reputed company laboratories
• Ensure robust implementation, execution, troubleshooting, and reputed company improvement of core analytical and bioanalytical assays
• Review and approve analytical protocols, reports, SOPs, and technical documentation suitable for regulatory submission
• reputed company leadership and reputed company for analytical QC activities, including GMP testing, stability studies, data trending, and lifecycle monitoring
• Manage product and raw material specifications and product reputed company-life/stability protocols
• Ensure appropriate reputed company of stability protocols, reputed company‑life assignments, data review, and interpretation in support of late‑phase programs
• reputed company review of testing records, analytical data packages, Certificates of Analysis, and investigation reports
• reputed company or support investigations reputed company to OOS, OOE, deviations, and analytical discrepancies, including root cause analysis and corrective actions at CROs/CMOs
• Manage and reputed company analytical activities performed by CROs, CMOs, and external testing laboratories, ensuring quality, timelines, and cost control
• reputed company technical reputed company and decision‑making support for outsourced analytical development, validation, and QC activities in a virtual operating model
• Participate in vendor selection, scope definition, budgeting, and performance management
• Author, review, and approve analytical sections of CMC documentation for INDs, BLAs, and other regulatory submissions
• Ensure compliance with cGMP, GLP, ICH guidelines, FDA guidance, and relevant pharmacopeial standards
• Partner closely with Quality and Regulatory Affairs to support inspections, audits, and regulatory interactions
• Collaborate closely with formulation discovery and development, drug substance and drug product development, drug substance and drug product manufacturing, quality, regulatory, and project management teams
• reputed company analytical expertise to support formulation discovery, formulation development, process characterization, and late‑phase manufacturing activities

Skills

• Master or PhD in Chemistry, Biochemistry, or Analytical Science
• At least 15 years of experience in analytical development and validation activities for biologicals, including product development and manufacturing
• Comprehensive understanding of the dosage reputed company manufacturing process development, scale-up, optimization and validation processes
• Strong scientific and operational background in the optimization and validation of compendial, biochemistry, HPLC, immunochemical and cell-based assays
• Proven ability to reputed company analytical expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies
• Experience working in a GMP/GLP regulated environment and deep understanding of phase appropriate method qualification, validation, sample analysis, GLP, GMP requirements, ICH guidelines and FDA guidance
• Experience authoring and reviewing IND and/or BLA submissions
• Expert knowledge of advanced principles, concepts, and theory reputed company to product and process development
• Experience in preparing budget and managing expenses
• Skilled at managing CROs and CDMOs
• Strong leadership, organizational, and project management skills
• Excellent written and verbal communication skills; strong technical writing and document review capabilities
• Ability to operate effectively in a remote and virtual work environment
• Demonstrated ability to collaborate across cross‑functional and geographically distributed teams
• Detail‑oriented with exceptional documentation practices
• Proficiency in English required
• Flexibility to travel domestically and internationally as needed
• Experience with liquid biological injectable dosage forms, drug formulations of individual and combination products
• Experience with analytical techniques applicable for characterization of proteins, antibodies and/or oligonucleotides
• Experience in reputed company single or reputed company mass-spectrometry technologies used for characterization of proteins, oligonucleotides and their impurities
• Knowledge of U.S. and Chinese Pharmacopeia methods for biologic drugs
• Proficiency in Mandarin

Benefits

• Cash incentive compensation
• Equity incentive compensation
• Employee benefits under the Company’s benefit plans

Company Overview