The Associate Director is both a hands-on and a leadership role within technical operations in delivering analytical support for pipeline products, mentoring, and coaching junior team members for professional growth, and developing best practice standardizing and streamlining operational procedures.

Responsibilities

• Lead, track, and document multiple Analytical Development programs for pipeline products from early development to commercial
• Provide analytical support for Process Chemistry and Formulation Development as needed
• Manage and oversee all analytical laboratory functions at CMOs in support of assigned development compounds
• Conduct analytical technical review of QC data generated at CMOs for release, stability, method validations, etc.
• Work with CMOs to develop appropriate methodologies, including stability indicating methods, to support release and stability testing of development compounds for non-clinical and clinical studies and commercial distribution
• Manage the transfer and/or validation of analytical methods to CMOs and independent contract testing laboratories. Provide ongoing analytical assistance to CMOs (e.g., method change or optimization)
• Participate in the development and management of stage appropriate stability programs
• Participate in theestablishment and justification of all specifications for drug substances and drug products
• Provide analytical expertise for manufacturing and testing deviations, OOS/OOT investigations working in concert with Quality Assurance to ensure proper disposition of affected materials
• Provide assistance with in-depth technical reviews for manufacturing and support global CMC regulatory submissions
• Interface effectively with other scientific disciplines (e.g., Quality Assurance, Analytical Chemistry/DMPK, Process Chemistry, and Formulation Development)
• Supports operational budgets, cost controls and resource planning to meet corporate strategic objectives
• Represents AD at interdepartmental meetings

Qualifications

• Ph.D. in Analytical Chemistry or related discipline with 8 years of pharmaceutical development industry experience in AD, as well as Quality Control (QC)
• Demonstrated record of excellence, in leadership and management of AD/QC in a small molecule drug development industry environment
• Experienced in leading AD/QC teams and projects in support of all stages of drug development
• Expert knowledge and hands-on experience with chromatographic methods and modern analytical instrumentation
• Highly organized and self-motivated
• Excellent interpersonal communication and decision-making skills
• Expert knowledge of cGMP compliance, ICH guidelines, compendial standards, and HA regulations pertaining to pharmaceutical manufacturing, method validations, product specifications, stability programs and other QC/AD activities
• Demonstrated ability to manage external contractors to meet or exceed Company goals
• Proficient in writing technical reports and AD/QC sections of CMC regulatory documents
• Demonstrated ability to effectively manage multiple products and projects
• Demonstrated ability for systematic methods of paper and electronic document organization, retention, and retrieval