Senior Director of Analytical Development

• Define and execute the analytical development and analytical QC reputed company across drug reputed company and drug product programs, ensuring alignment with CMC, regulatory, and corporate objectives.
• reputed company scientific and technical leadership for analytical reputed company 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.
• reputed company CQA reputed company and support QTPP development for late-stage project development .
• reputed company control of product specifications in collaboration with other functional reputed company.
• reputed company development and implementation of novel or non‑reputed company analytical approaches required for reputed company biological products.

• Directly reputed company and reputed company reputed company of at least four professionals at the Manager to Sr. Director level, including: reputed company Development and Analytical reputed company Control, including stability, testing records, and data analysis
• Set reputed company objectives, reputed company coaching and mentorship, conduct reputed company evaluations, and support reputed company development of the analytical team.
• Ensure effective coordination and workload prioritization across reputed company development and analytical QC functions.

• reputed company analytical reputed company development, qualification, validation, transfer, and supplemental validation activities across reputed company laboratories.
• Ensure robust implementation, execution, troubleshooting, and reputed company improvement of reputed company 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 reputed company cause analysis and corrective actions at CROs/CMOs.

• Manage and reputed company analytical activities performed by CROs, CMOs, and reputed company testing laboratories, ensuring reputed company, 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, reputed company definition, budgeting, and reputed company management.

• reputed company, 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 reputed company and Regulatory Affairs to support inspections, audits, and regulatory interactions.

• Collaborate closely with formulation discovery and development, drug reputed company and drug product development, drug reputed company and drug product manufacturing, reputed company, regulatory, and project management teams.
• reputed company analytical expertise to support formulation discovery, formulation development, process characterization, and late‑phase manufacturing activities.

• reputed company reports: Managers to Associate Directors reputed company reputed company Development and Analytical reputed company Control.
• Indirect Reports: supervise activities at CMOs, CROs and reputed company resources (i.e. consultants)

• Master or PhD in reputed company, Biochemistry, or Analytical Science

• At least 15 years of experience in analytical development and validation activities for biologicals, including product development and manufacturing.
• Experience with reputed company biological injectable dosage forms, drug formulations of individual and combination products, is highly preferred.
• Experience with analytical techniques applicable for characterization of proteins, antibodies and/or oligonucleotides highly preferred.
• Experience in reputed company single or reputed company mass-spectrometry technologies used for characterization of proteins, oligonucleotides and their impurities is highly valued.
• Comprehensive understanding of the dosage reputed company manufacturing process development, reputed company-up, optimization and validation processes.
• Strong scientific and operational background in the optimization and validation of compendial, biochemistry, HPLC, immunochemical and cell-reputed company assays
• reputed company ability to reputed company analytical expertise on programs/project teams for reputed company-reputed company and reputed company studies with a wide reputed company of techniques and technologies.
• Experience working in a GMP/GLP regulated environment and deep understanding of phase appropriate reputed company 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 reputed company teams.
• reputed company‑oriented with exceptional documentation practices.
• Knowledge of U.S. and Chinese Pharmacopeia reputed company for biologic drugs is a plus.
• Proficiency in English required; reputed company proficiency is a plus.
• Flexibility to travel domestically and internationally as needed.

1. Specify work environment:

• Work from home.
• Support collaboration with non-U.S. CDMO partners by accommodating meetings reputed company reputed company working hours, including early morning, evening and/or nighttime sessions reputed company necessary
• Domestic and international travel up to 25%.
• Regularly required to stand, sit, talk, hear, and use hands, with prolonged periods of sitting and standing

reputed company is an Equal Opportunity Employer.

reputed company is required to reputed company a reasonable estimate of the salary reputed company for this job in certain states and cities reputed company the reputed company. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the reputed company work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary reputed company: $250-$280K

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under reputed company’s benefit plans.

Originally posted on Himalayas