Engineer/Scientist, Drug Product Process Development and Manufacturing at Praxis Precision Medicines, Inc.

, , United States -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

129000.0

Posted On

31 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Oral Solid Dosage Formulation, Manufacturing, Process Design, Equipment Selection, Scale-up, Facility Fit, Technology Transfer, Process Validation, CDMO Management, cGMPs, Regulatory Requirements, Quality Systems, Process Modeling, Data Analysis, Root Cause Investigation, Problem-solving

Industry

Biotechnology Research

Description

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is seeking a mission-driven, detail-oriented Engineer/Scientist to lead formulation and external manufacturing efforts for oral solid dosage (OSD) products across our clinical pipeline. This is a builder role that is ideal for someone with deep technical know-how and a bias toward action. You’ll work cross-functionally to develop scalable formulations, drive process optimization, manage CDMO relationships, and ensure successful tech transfers and validation - all in service of getting life-changing therapies to patients faster. Primary Responsibilities Design and optimize robust oral solid dosage formulations for clinical and commercial development. Lead tech transfer activities from development to external manufacturing, ensuring seamless scale-up and validation. Author and review key technical documentation including batch records, master manufacturing records, and process validation protocols. Investigate and resolve deviations and batch failures in collaboration with QA, Regulatory, and CDMO partners. Serve as the technical point of contact for CDMO selection, oversight, and performance management. Drive process improvements using QbD and risk-based approaches to meet quality, regulatory, and timeline expectations. Collaborate with cross-functional teams to ensure end-to-end alignment. Qualifications and Key Success Factors Bachelor's degree or master's Degree in chemical engineering strongly preferred; may consider BSc/MS in pharmaceutical sciences or related discipline. 6 to 8 years of experience in oral solid dosage formulation and manufacturing, with a strong foundation in engineering principles such as process design, equipment selection, scale-up, and facility fit. Demonstrated expertise in technology transfer and process validation, including authoring protocols and leading execution at external sites. Proven success managing CDMO relationships and driving performance in outsourced manufacturing environments. Deep understanding of cGMPs, regulatory requirements, and quality systems with a process engineering lens. Skilled in process modeling, data analysis, and root cause investigation for manufacturing deviations. Proactive problem-solver who thrives in ambiguity, acts with urgency, and brings rigor and precision to complex challenges. Strong communicator and collaborative team member who contributes without ego. 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. 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 $112,000—$129,000 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 careers@praxismedicines.com. 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.

Responsibilities

Design and optimize robust oral solid dosage formulations for clinical and commercial development. Lead tech transfer activities from development to external manufacturing, ensuring seamless scale-up and validation.