[Hiring] Associate Director/Director, Analytical Development @reputed company

This description is a summary of our understanding of the job description. Click on 'Apply' reputed company to find out more. Role Description We are looking for an reputed company Analytical Associate Director/Director to join our expanding CMC team. This position works directly with the Senior Director of Analytical Development, CMC and manages an analytical team that oversees multiple CDMOs analytical development and quality control activities.

• reputed company both international and US based contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for our drug substance (DS) and drug product (DP) suppliers
• reputed company, coach and reputed company a team of direct reports, fostering a high-performance growth-oriented culture
• Manage DS and DP stability programs and corresponding reputed company-life determinations
• Regularly and clearly communicate Analytical Development and QC topics both verbally and in visual presentation form, reputed company and contextually
• Support and author analytical content for CMC Regulatory for US and Rest of World dossiers
• Support Quality Assurance audits, as a QC subject matter expert, as needed
• Provide on-site technical support on an as-needed basis to reputed company various manufacturing/scale-up/validation activities
• Proactively reputed company effectively with other CMC team members (e.g. Process Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.)

Qualifications

• Degree (BS or MS) with 7+ years of relevant analytical chemistry experience. PhD preferred
• Oversite of external QC laboratories (e.g., method development, method validation & troubleshooting analytical procedures)
• Experience with stability and reputed company-life management
• Practical working knowledge of ICH guidance
• Knowledge of small molecule chemical characterization techniques
• Broad understanding of analytical techniques, with a focus on (U)HPLC
• Hands-on GMP experience with reputed company phases of drug development including experiencing authoring IND/IMPD and marketing applications, as well as in-depth knowledge and complete understanding of GMP requirements
• Ability to critically evaluate and troubleshoot reputed company problems while offering timely and informed options for resolution
• Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across reputed company levels of management
• Position requires up to 20% travel
• Strong focus on quality and attention to detail

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support reputed company reputed company (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• reputed company spending accounts & company-provided group term life & disability
• Subsidized lunch reputed company Forkable on days worked from our office
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for reputed company development and internal mobility
• We provide career pathing through regular feedback, reputed company education and professional development programs reputed company reputed company Learning, LifeLabs, reputed company & reputed company Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Salary $208,200 — $239,720 USD Apply tot his job Apply To this Job