Senior Manager, Process Engineer United States - Remote

Company: Tbwa Chiat/Day Inc
Location: Boston
Posted on: November 18, 2024

Job Description:

Location: This position may be performed remotely with travel to the Boston area as needed.The OpportunityWe 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 resultsCompany OverviewPraxis 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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Keywords: Tbwa Chiat/Day Inc, Chicopee , Senior Manager, Process Engineer United States - Remote, Engineering , Boston, Massachusetts