We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Director of Pharmaceutical Process Engineering
Location
United States
Posted
8 days ago
Salary
Not specified
Job Description
Role Description
This role involves leading the development and manufacturing processes of drug substances, playing a crucial role from preclinical through commercial launch.
- Plan, direct, and oversee drug substance process development from pre-clinical to commercial launch.
- Oversee scale-up and scale-down activities between laboratory and manufacturing.
- Evaluate and manage external partners ensuring compliance with GMP regulations.
- Optimize processes using Quality by Design (QbD) principles.
- Prepare timelines and set clear project deliverables.
- Collaborate on regulatory filings and author technical documents.
- Stay informed on industry trends and regulatory guidance.
- Mentor and develop direct reports and team members.
Qualifications
- Advanced degree (PhD/Masters) in Chemical Engineering or related field.
- Minimum of 10 years experience in the pharmaceutical industry.
- 8 years in a supervisory role.
- Hands-on experience with GMP and CMC regulatory requirements.
- Technical project leadership experience in drug substance development.
- Expertise in QbD principles and risk assessments.
- Proven track record for mentoring and developing team members.
- Strong communication skills and experience with CMC documentation.
Benefits
- Competitive salary range: $186,000 - $232,000.
- Discretionary annual target bonus.
- Stock options and Employee Stock Purchase Plan (ESPP).
- 401(k) match and top-notch health insurance plans.
- 20 days of PTO and 10 paid holidays.
- Winter company shutdown.
Job Requirements
- Advanced degree (PhD/Masters) in Chemical Engineering or related field.
- Minimum of 10 years experience in the pharmaceutical industry.
- 8 years in a supervisory role.
- Hands-on experience with GMP and CMC regulatory requirements.
- Technical project leadership experience in drug substance development.
- Expertise in QbD principles and risk assessments.
- Proven track record for mentoring and developing team members.
- Strong communication skills and experience with CMC documentation.
Benefits
- Competitive salary range: $186,000 - $232,000.
- Discretionary annual target bonus.
- Stock options and Employee Stock Purchase Plan (ESPP).
- 401(k) match and top-notch health insurance plans.
- 20 days of PTO and 10 paid holidays.
- Winter company shutdown.
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