RemoteLeaf Logo
Log in Sign up

Associate Director, Drug Product Development

1 hour, 55 minutes ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 15

Description

  • Serve as the technical contact for CDMOs supporting drug product manufacturing and release activities.
  • Lead oversight of drug product development work, including process development, tech transfer, scale-up, and validation.
  • Provide technical leadership for clinical and commercial manufacturing campaigns, including review and approval of batch records, plans, protocols, reports, and investigations.
  • Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges.
  • Develop and support process validation strategies in collaboration with internal and external stakeholders.
  • Oversee preparation, review, and approval of validation documentation, including PPQ protocols and reports, risk assessments, control strategies, and CPV plans.
  • Evaluate manufacturing performance data to identify trends, process capability concerns, and improvement opportunities.
  • Lead secondary packaging development activities for a late-stage drug product.
  • Support packaging design, component selection, labeling inputs, packaging line considerations, and secondary packaging validation with external partners and internal stakeholders.

Requirements

  • Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline.
  • 10+ years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, or related CMC functions.
  • Demonstrated experience supporting outsourced manufacturing models and managing CDMOs in a virtual company environment.
  • Strong working knowledge of cGMP requirements for OSD manufacturing.
  • Strong working knowledge of drug product process development, formulation development, tech transfer, scale-up, and PPQ.
  • Strong working knowledge of ICH Q8/Q9/Q10 and risk-based validation principles.
  • Strong working knowledge of manufacturing investigations and change management.
  • Proven ability to technically oversee and influence external manufacturing partners.
  • Experience supporting regulatory submissions and PAIs for solid oral dosage products (preferred).
  • Experience with lifecycle management, CPV programs, and post-approval change management (preferred).
  • Experience authoring or reviewing CMC sections for regulatory submissions related to drug product manufacturing (preferred).
  • Familiarity with statistical tools used for data analysis (preferred).
  • Prior experience in a virtual or highly outsourced biotech environment (preferred).

Benefits

  • Starting base salary of $150,000 to $202,351, depending on skill set, years of experience, and geographic location.
  • Additional compensation may include bonus and equity.
  • 100% paid medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match.
  • 401(k) vesting begins after the first month of employment.
  • Flexible time off.
  • Generous parental leave.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Buyers Edge Platform

Director, Events

Buyers Edge Platform 251-1K IT Services

Buyers Edge Platform is hiring a remote Director, Events to lead divisional event strategy, execution, and ROI across a complex foodservice portfolio.

Anywhere Full-time Lead Head of Marketing Program Manager
55 minutes ago
Figma

Technical Program Manager, Infrastructure

Figma 1K-5K Internet Software & Services

Figma is seeking a Technical Program Manager to partner with its Infrastructure team on large-scale cross-company engineering efforts that improve scalability, performance, reliability, and delivery of critical infrastructure projects.

United States Full-time Senior Program Manager
$185k-$317k
AWS DynamoDB Figma GCP Kafka OpenSearch Redis
55 minutes ago
Cribl

Staff Technical Program Manager, AI

Cribl 251-1K IT Services

Cribl is seeking a Staff Technical Program Manager to lead complex product and engineering programs for its AI-era telemetry platform, with a focus on delivery, operational readiness, and cross-functional alignment.

United States Full-time Lead Program Manager
$115k-$179k
AWS Azure Bitbucket GitHub Jenkins Machine Learning
55 minutes ago
Databricks

Program Manager, Product

Databricks 1K-5K IT Services

Databricks is hiring a Program Manager for Product Legal to run operational workflows that help legal teams advise engineering and product on global compliance for its software offerings.

United States Full-time Senior Program Manager
$132k-$182k
JIRA
1 hour, 10 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