Sr. Director/Executive 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.

Affiliate Overview

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You’ll Do

BridgeBio seeks a Sr. Director/Executive Director, Analytical Development to lead our analytical development (AD) and commercial quality control (QC) groups supporting our late-stage novel small molecule development programs. While this position is responsible for authoring and revising analytical development (AD) sections of regulatory submissions (e.g., IND, IMPD, NDA, MAA, etc.), input on CMC regulatory strategy for both drug substance (DS) and drug product (DP) across the BridgeBio cardiorenal small molecule portfolio is also expected. Therefore, a comprehensive understanding of relevant ICH guidelines and health authority expectations for small molecule new chemical entities (NCEs) is required.   

As BridgeBio is a virtual organization, external CDMO management experience is a plus. Additional responsibilities include oversight of late development/launch preparation activities, including analytical method transfers, method development, phase-appropriate validation for both DS and DP and the review of analytical packages for the release of clinical/commercial supplies. The position requires close collaboration with drug substance and formulation scientists and Quality Assurance. Working knowledge of GMPs, various small molecule analytical techniques, including HPLC, GC, GC/MS, LC/MS, ICP, dissolution (discriminating and USP), UV, IR, NMR, XRPD, Karl Fischer titration, DSC, and TGA is required—excellent communication skills (both verbal and written) a must.

Responsibilities

• Proven leadership experience in managing analytical chemists at various levels, externally (CRO/CMO management) and internally (direct report management)
• Experience writing, reviewing, and responding to queries on all Module 3 analytical sections of BridgeBio Cardiorenal CTDs.  Expected to contribute to the overall control strategy for all regulatory filings (incl. DS and DP)
• Candidates with prior NDA/MAA authoring experience will be preferred. Prior NCE filing experience is a plus
• Management of direct reports
• Sophisticated understanding of how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities and expectations
• Travel, when necessary, to third-party manufacturing and/or testing sites
• Oversight of third-party development of analytical methods, method validation, and investigations for out-of-specification, out-of-trend, and/or anomalous results
• Collaboratively plan and execute cross-functional studies for chemical development and formulation development
• Proficiency in various analytical techniques and regulatory areas, including HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase-appropriate analytical method validation
• Experience with various solid-state characterization techniques, including XRPD, PSD measurement, DSC, and TGA, as well as familiarity with drug product (disintegration, hardness, and friability) testing, is also desired
• Responsible for developing phase-appropriate qualifications and/or validating requisite analytical methods.  The ideal candidate will be familiar with current statistical techniques used in method development and validation
• Able to communicate results internally and externally through verbal and written updates and formal reports as necessary

Where You’ll Work

This is a U.S.-based remote role that will require monthly visits for the first six months of onboarding and then scheduled visits to our San Francisco Office as needed. 

Who You Are

• Ph.D./M.S. in life sciences, ideally Chemistry or Analytical Chemistry, with 10+ years of experience in analytical development in a pharmaceutical setting.  B.S. will be considered with/an additional 5 years of industrial experience
• Proven abilities in leadership and personnel management
• Knowledge and direct experience with CMC analytical requirements for IND and NDA/MAA filing
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
• Strong oral and written communication skills

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