Job details
Job type full-time
Full job description
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 imbalancePraxis is applying insights from genetic epilepsies to broader neuronal and psychiatric disorders, using our understanding of shared biological targets and circuits in the brain.
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.
Praxis has established a broad portfolio, including multiple disclosed programs across central nervous system disorders including depression, epilepsy, movement disorders and pain syndromes, with three clinical-stage product candidatesTrust, ownership, curiosity, and results are foundational in every aspect of our business and are exemplified by each and every one of our team members.
Primary responsibilities
Development of clinical and commercial drug product, processes and controls.
Part of the overall cmc team responsible for delivery of clinical and commercial cmc to praxis programs
Identification, collaboration and leadership of external cmo and cdmo organization and resources from lab to plant floor
Contributor to regulatory submissions
Defining manufacturing strategy and execution, including gmp requirements and issue resolution
Assessment and application of new trends and concerns in formulation and manufacturing to praxis products
Assessment of physicochemical and preformulation data to define drug product strategy.
Contributor to inventions which add value to praxis and its patients while strengthening our intellectual property position
Education and professional preferred experience
Advanced degree or commensurate experience equivalent in chemistry, pharmaceutical sciences, engineering or related discipline
Minimum of 5 years industry experience in cmc specifically for small molecule drug substance and solid oral drug products
Track record of bringing medicines from the laboratory to the clinic and then to the marketplace
Strong knowledge of us and eu cgmp requirements and best practices relating to drug substances and drug products
Strong knowledge of cmc development across all phases of drug development from initial regulatory filings through registration, validation and launch
Experience in working with third-party cro / cmo partners and associated service providers to develop and manufacturing pharmaceutical products
Other essentials and key success factors
Able to work across and bring together colleagues across function
Demonstrates voracious intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment
Ability to think critically with a keen sense of urgency and demonstrated problem solving abilities
Self-motivated, able to influence and guide the work of other team members, and contribute to a productive and collaborative team environment
Highly organized and detail-oriented with a passion to deliver quality results
Strong verbal and written communication skills with an ability to build relationships internally and externally
Comfortable with independently making decisions and communicating in a direct fashion
Approaches his/her work with high levels of professionalism, integrity and personal confidence
Track record of recruiting and developing staff as well as pulling teams together
Additional requirement
To safeguard the health of our employees and their families, our partners and visitors, and our communities, praxis requires that all employees be fully vaccinated against covid-19 and provide proof of vaccination before beginning employment, except where prohibited by lawRequests for exemption will be considered and praxis will provide reasonable accommodations unless doing so would pose an undue hardship.
