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Senior Manager, Process Engineer

United States - Remote

Location:  This position may be performed remotely with travel to the Boston area 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 validate processes related to the manufacture of small molecule Active Pharmaceutical Ingredients (APIs).  You will also oversee future commercial production to ensure appropriate supply levels are available.  The ideal candidate is an engineer experienced with leading the day-to-day communications with the CMO as well as being the Point of Contact (POC) from Praxis for all information knowledge transfer (to and from 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, 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)


Qualifications and Key Success Factors

  • Advanced degree in chemical engineering or other relevant engineering field, MS or equivalent a plus. Pharmaceutical or fine chemical industry experience required.
  • 8 years' experience with a BS degree or 6 yrs with a MS degree of applied experience in CMO management, chemical manufacturing, or comparable positions that handle diverse chemical syntheses in laboratory and manufacturing 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
  • REQUIRED:  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.

 

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

  • 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
  • Bonus program structured to pay on a quarterly basis
  • 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
  • Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
  • Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
  • Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

 

Annualized Base Salary

$165,000 - $180,000 USD

Company Overview 

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.

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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.

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