Senior Process Engineer, Drug Substance

About the role

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 escalate 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.

Additional information

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.

Compensation & Benefits

• 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.

Annualized Base Salary $110,000—$125,000 USD

Diversity, Equity & Inclusion

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