Process Engineer - Packaging

Location: This position may be performed remotely with travel to the Boston area as needed. Position Summary: 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 primary and secondary packaging of drug product. 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: • Deep knowledge of primary and secondary packaging materials and processes for oral drug products as well as labeling and serialization requirements. Bottling, blistering, walleting, cartoning of oral drug products, including tablets, gel caps, and powders. Cold chain and parenteral knowledge, a plus. • 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: • Degree in packaging, mechanical or other relevant engineering field, MS or equivalent a plus. Pharmaceutical experience required. • 5 years’ with a BS degree or 2 years’ with an MS degree of applied experience in CMO management, final 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 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 compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience. Annualized Base Salary $100,000—$120,000 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. 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. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to [email protected]. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. Apply tot his job