RemoteLeaf Logo
Log in Sign up

Director or Senior Director, API Development

4 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 10

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

Similar Roles

CI&T

[Job-29179] Senior Python AWS, Brazil

CI&T 5K-10K Internet Software & Services

CI&T is hiring a Senior Python AWS engineer in Brazil to design and deliver mission-critical serverless and generative AI solutions for complex business processes.

Brazil Full-time Senior AI Engineer Backend Engineer
API Gateway AWS Datadog DynamoDB Generative AI Microservices Python REST API
1 hour, 1 minute ago
emerchantpay

Senior Ruby/Rails Back-End Developer

emerchantpay 251-1K Diversified Financial Services

emerchantpay is hiring experienced Ruby on Rails developers to build and scale payment platform components for a global payments business.

Bulgaria Full-time Senior Backend Engineer
Ansible AWS BDD Docker GraphQL JavaScript MySQL PostgreSQL RabbitMQ React Redis RSpec Ruby Ruby on Rails TDD Terraform
1 hour, 1 minute ago
Binance

Backend Engineer - Payment (Java)

Binance 5K-10K Capital Markets

Binance is hiring a Backend Engineer for its Payments team to build and improve crypto payment systems and core financial products for global users and partners.

Taiwan Hong Kong Full-time Mid Level Backend Engineer
Blockchain Java Microservices MySQL SQL
1 hour, 10 minutes ago
Pavago

Software Engineer - Go Specialist

Pavago IT Services

Pavago’s client is hiring a remote Software Engineer (Go/Golang Backend) to build and scale the backend infrastructure for a modern cybersecurity platform, with a focus on high-scale data processing, integrations, and distributed systems.

Mexico Argentina Brazil Colombia Costa Rica Full-time Senior Backend Engineer
AWS Azure Cybersecurity GCP Go Java Microservices OAuth PostgreSQL Python REST API SIEM TypeScript
1 hour, 17 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers