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Associate Director / Director, CMC, Technical Operations

Associate Director / Director, CMC, Technical Operations

BridgeBioPalo Alto, CA, US
1 day ago
Job type
  • Full-time
Job description

Associate Director / Director, CMC, Technical OperationsWhat 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.

  • Market leading compensation
  • 401K with 100% employer match on first 3% & 50% on the next 2%
  • Employee stock purchase program
  • 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 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

    • BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

    $160,000 - $245,000 USD

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    Associate Technical • Palo Alto, CA, US