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Director or Senior Director, API Development

1 month, 3 weeks ago
Anywhere
Full-time
Lead
Backend Engineer
Software Development
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 8

Description

  • Provide technical leadership for selection, transfer, and management of new CDMO manufacturing activities.
  • Lead current drug substance manufacturing processes and drive continuous improvement efforts.
  • Support ongoing CDMO manufacturing activities and troubleshoot issues and non-conformities.
  • Identify and resolve regulatory compliance gaps related to drug substance manufacturing and development.
  • Support formulation development through drug substance optimization, impurity identification, and pre-clinical study support.
  • Author and review drug substance IND-enabling protocols, reports, and regulatory submissions.
  • Engage in new entity optimization and synthetic route creation and advancement.
  • Prepare intellectual property patent assessments and support development projects that advance IP generation.
  • Perform additional duties as assigned.

Requirements

  • PhD, Master’s, or Bachelor’s degree in a physical science field, preferably chemistry, chemical engineering, or biomanufacturing.
  • At least 8 years of experience in small molecule medicinal chemistry, API development, and/or manufacturing.
  • Experience with early development activities, including IND-enabling development and authoring.
  • Experience managing CDMOs for initial development, manufacturing, process validation, and transfer activities.
  • Knowledge of analytical technologies such as LC, GC, NMR, MS, and XRPD for elucidation and purity determination.
  • Working knowledge of FDA, EU, and ICH guidelines for drug substance manufacturing and quality assurance.
  • Excellent written and verbal communication skills with the ability to influence and build credibility at all levels.
  • Strong interpersonal skills for working across employees and leaders in multiple functions.
  • Attention to detail and ability to manage multiple processes and documentation requirements.
  • Advanced knowledge of ChemDraw and MS Office, including Word, Excel, and PowerPoint.
  • Strong organizational, prioritization, and independent decision-making skills in a fast-paced environment.

Benefits

  • Base salary range of $220,000 to $240,000, depending on geography, qualifications, skills, and experience.
  • Annual performance incentive bonus.
  • New hire equity package.
  • Medical, dental, and vision insurance.
  • 401(k) match.
  • PTO and paid holidays.

Interested in this position?

Apply directly on the company website

Apply Now

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