Senior Manager, Process Engineer - Drug Product jobs in United States
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Praxis Precision Medicines, Inc. · 14 hours ago

Senior Manager, Process Engineer - Drug Product

Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. They are seeking a skilled Process Engineer to optimize drug product manufacturing processes and ensure readiness for commercial production by collaborating with Contract Manufacturing Organizations.

Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Ability to understand varied formulation processes and transfer drug product processes for industrialized execution by authoring scale up spreadsheets and process manuals
Efficient use of technologies and applications to gather, analyze and archive large data packages that can support regulatory filings
Review relevant documentation from CMOs and lab partners including instructions, procedures, batch records, non-conformances, in-process controls, bulletin of analysis, developmental reports
Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all our processes being executed by third parties
Adhere to industry guidelines, standards and laws including being well-versed in cGMPs
Travel required - PIP at CMOs (US and worldwide)

Qualification

Process engineeringDrug product manufacturingCMO managementCGMP knowledgePharmaceutical industry experienceVisual communicationWritten communicationTeam collaborationDetail-oriented

Required

Advanced degree in chemical engineering, pharmaceutical sciences or other relevant engineering field, MS or equivalent a plus
Pharmaceutical industry experience required, e.g. process operations knowledge of sifting, milling, blending, roller compaction, tableting, coating among others
8 years' with a BS degree or 6 years' with an MS degree of applied experience in CMO management, drug product manufacturing, or comparable positions that handle diverse environments, reviewing Manufacturing and Executed Batch records, operating procedures, non-conformances, change controls, and fostering business partner relationships
Excellent written and visual communication skills with an ability to build relationships internally and externally
Self-motivated and able to contribute to a productive and collaborative team environment
Highly organized and detail-oriented with a passion to deliver quality results

Benefits

99% of the premium paid for medical, dental and vision plans.
Company-paid life insurance
AD&D
Disability benefits
Voluntary plans to personalize your coverage.
We match dollar-for-dollar up to 6% on eligible 401(k) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Extremely flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns

Company

Praxis Precision Medicines, Inc.

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Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.

H1B Sponsorship

Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)

Funding

Current Stage
Public Company
Total Funding
$1.67B
Key Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M

Leadership Team

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Marcio Souza
President and CEO
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Tim Kelly
Chief Financial Officer
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Company data provided by crunchbase