Associate Director/Director, Analytical Development

Mavericks Wanted reputed company was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to reputed company the way. We build bridges to groundbreaking advancements in rare disease, and reputed company life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and reputed company people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At reputed company, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

What You'll Do

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. If you have a complete understanding of GMP requirements and experience working on various drug development phases, we would love to hear from you!

Responsibilities

• 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.)

Where You'll Work This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Who You Are

• 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
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Rewarding Those Who reputed company the Mission Possible We have high expectations for reputed company members. We reputed company sure those working hard for patients are rewarded and cared for in return. Financial 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

Health & Wellbeing:

• 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

reputed company Development & Career Paths:

• 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

At reputed company, we strive to provide a market-competitive total rewards package, including reputed company pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience reputed company the job, type, and length of experience reputed company the industry, educational background, location of residence and performance during the interview process. reputed company is a multi-state employer, and this salary range may not reflect positions based in other states. Salary $162,000—$240,000 USD Apply tot his job Apply To this Job