Associate Director/Director Pharmaceutical Development

1 month, 1 week ago
Full-time
Senior
Operations
bridgebiowp

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals
251-1K
Founded 2014
$2300M raised

Description

  • Provide strategic pharmaceutical development guidance to cross-functional project teams as the CMC lead.
  • Develop robust formulations and manufacturing processes to support development and rapid registration of QED products.
  • Review development and manufacturing programs at CROs and external vendors for compliance with proposals, quality standards, and timelines.
  • Review external data and manage drug forecasts and associated transactions.
  • Integrate and liaise effectively with the CMC team.
  • Support preparation of regulatory submissions, including IB, IND, and NDA documents.
  • Develop complex formulations for pediatric indications.
  • Work effectively with CDMOs in a fast-paced, tight-timeline environment.
  • Manage clinical supply, formulation development, and clinical trial manufacturing at CROs.
  • Apply knowledge of commercial manufacture and CMC regulatory requirements for the US and EU.

Requirements

  • PhD or advanced degree in Chemistry or Pharmacy.
  • 7+ years of bio/pharmaceutical industry experience in formulation development and clinical supply.
  • Expertise in formulation development.
  • Knowledge of PK/PD principles and ADME concepts.
  • Experience with regulatory documentation and authorship.
  • Knowledge of import/export sensitivities.
  • Demonstrated ability to manage clinical supply, formulation development, and manufacturing at CROs.
  • In-depth knowledge of CMC regulatory requirements for the US and EU.
  • Hands-on experience in clinical trials management, study conduct, formulation development, and clinical trial manufacturing.
  • Remote role with 30% travel expected.

Benefits

  • Market-leading compensation.
  • Annual performance bonus.
  • Company equity and employee stock purchase program.
  • 401(k) with employer match.
  • 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • HSA with annual employer contributions and FSA options.
  • Flexible, take-what-you-need paid time off and company-paid holidays.
  • Comprehensive paid medical and parental leave.
  • Expanded mental health support, including therapy and coaching resources.
  • Hybrid work flexibility.
  • Subsidized lunch and parking on in-office days.
  • Referral bonus for hired candidates.

Interested in this position?

Apply directly on the company website

Apply Now

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