Associate Director/Director, Analytical Development

Mavericks Wanted

When 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 lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower 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.

What You'll Do

We are looking for an experienced 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

•  Oversee 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
• Lead, coach and develop a team of direct reports, fostering a high-performance growth-oriented culture
• Manage DS and DP stability programs and corresponding shelf-life determinations
• Regularly and clearly communicate Analytical Development and QC topics both verbally and in visual presentation form, efficiently 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 oversee various manufacturing/scale-up/validation activities
• Proactively interface 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 shelf-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 all 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 complex 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 all levels of management 
• Position requires up to 20% travel 
• Strong focus on quality and attention to detail 

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make 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 via Spring Health (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
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill 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 skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities