Senior Process Engineer, Drug Substance New United States - Remote

Praxis Precision Medicines, Inc.; Northern (KY); Remote; USD 110,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision plans (premium

Company-paid life insurance

AD&D

Disability benefits

401(k) matching up to 6%

Stock incentives/ESPP

PTO & holidays

Annual bonuses

Job summary

Praxis Precision Medicines, Inc. is seeking a Process Engineer to collaborate with CMOs for the development and validation of API manufacturing processes. You will translate lab-scale chemistry into industrial workflows, review regulatory-relevant documents, and support knowledge transfer between Praxis and CMOs.

The role emphasizes strong communication, problem solving, and willingness to travel for PIP activities at CMOs around the world, ensuring robust supply and compliance.

Qualifications

• BS or MS in chemical engineering or related field; pharma experience a plus.
• 4–8 years in CMO management or chemical manufacturing, reviewing batch records and change controls.
• Excellent written and visual communication; ability to build relationships internally and externally.
• Self-motivated and collaborative team player.

Responsibilities

• Translate lab-scale processes to industrialized scale by authoring scale-up spreadsheets and process manuals.
• Assemble and analyze large data packages for regulatory filings, archiving results.
• Review CMOs' documents: procedures, batch records, non-conformances, and change controls.
• Partner with Quality Assurance to ensure regulatory compliance in third-party processes.
• Adhere to cGMPs and industry guidelines; identify process risks and mitigation plans.
• Travel to CMOs and participate in in-person plant activities (US and worldwide).

Skills

Written communication

Data analysis

Collaboration

Detail-oriented

Education

Bachelor's or higher in chemical engineering

Job description

Location

This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

We are looking for a competent Process Engineer to work closely with our Contract Manufacturing Organizations (CMOs) in the field in order to support and validate processes related to the manufacture of small molecule Active Pharmaceutical Ingredients (APIs). You will also support future commercial production to help ensure appropriate supply levels are available. The ideal candidate is an engineer experienced with supporting day-to-day communications with the CMO as well as contributing to knowledge transfer activities between Praxis and the CMO.

Primary Responsibilities

• Ability to understand written chemical synthesis processes from lab partners and help translate those to instructions 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, certificates of analysis, and developmental reports.
• Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all processes being executed by third parties.
• Adhere to industry guidelines, standards and laws including being well-versed in cGMPs.
• Identify and elevate process risks and support development of mitigation plans.
• Travel required, participate in person-in-plant (PIP) activities at CMOs (US and worldwide).

Qualifications and Key Success Factors

• Bachelor’s or advanced degree in chemical engineering or other relevant engineering field; MS or equivalent a plus. Pharmaceutical or fine chemical industry experience required.
• 4–8 years of applied experience in CMO management, chemical manufacturing, or comparable positions that handle diverse chemical syntheses in laboratory and manufacturing environments, including reviewing manufacturing and executed batch records, operating procedures, non-conformances, and change controls, and supporting 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.

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.

Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

$110,000 - $125,000 USD

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. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.