Associate Director/Director, CMC, Technical Operations

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

BridgeBio is hiring an antibody manufacturing and analytical development scientist to expand its biologics-based pipeline. The candidate will help in developing physicochemical analytical methods (HPLC, CE, LC/MS), perform extensive characterization on both early and late-stage molecules for genetic rare diseases, and support process and formulation development through routine testing. This work is performed in-house and in collaboration with CROs/CDMOs. The position is primarily for antibodies, and prior experience is required.

Responsibilities

• Develop analytical methods, support extended characterization studies for antibody-based therapeutics
• Support process and formulation development by providing analytical testing results
• Work closely with various CRO/CDMO/CMO to ensure the timely development, validation, testing, and release of materials to be used to support clinical activities
• Author and review protocols, technical reports, and method SOPs
• Author and review module 3 sections for US and ex-US regulatory filings
• Management of CRO/CDMO/CMO analytical development activities and timelines
• Review analytical method transfer documentation and release/ stability data for drug substance and drug product
• Participate in CMC strategic planning & department leadership meetings

Where You'll Work

This position will be expected to be on-site 3 times per week in our Palo Alto office, and 1-2x per month in our San Francisco office.

Who You Are

• PhD 8-10 years or non-PhD 10-15 years of relevant industry experience
• Experience of state-of-the-art analytical technologies for biologics, such as HPLC (various modes and detections), CE-SDS, icIEF, LC-MS, peptide map, glycan map, disulfide map, DSC, FT-IR, CD, fluorescence spectroscopy, particle analysis
• Expertise and/or familiarity with the current analytical techniques for pharmaceutical development
• Thorough understanding of cGMPs, USP, and ICH guidelines, as well as industry best practices
• Experience managing CDMO/CRO from cell line development to successful IND/FIH
• Ability to communicate effectively with CRO/CDMO/CMO regarding project scope, scientific results, and project updates
• Knowledge and direct experience with CMC analytical requirements for IND and NDA/MAA filing
• Strong oral and written communication skills
• Proven abilities in leadership and personnel management

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