Principal Scientist, Formulation Development

Position Summary

The qualified candidate will be responsible for drug product development from lead optimization during drug discovery to late-stage clinical development, manufacture of clinical supplies, and development of efficient and scalable manufacturing processes. Experience and/or knowledge of preclinical formulation support, characterization of solution and solid-state properties of materials, formulation development, manufacturing process selection, development and scale up, and contract development and manufacturing organizations (CDMOs) management will be important considerations for candidacy.

Primary Responsibilities

• · Ability to represent Formulation on CMC teams and Pharmaceutical Development in multidisciplinary project teams, work collaboratively to ensure project progression, and communicate Formulation/Pharmaceutical Development strategy and related challenges.
• · Plan, design, and supervise the execution, and interpret laboratory experiments to properly characterize novel drug candidates (small molecules and/or ASO).
• · Apply formulation and manufacturing principles, theories and techniques to product development and develop the best possible phase appropriate formulations and manufacturing processes.
• · Work closely with drug discovery teams to ensure timely and high-quality support for preclinical studies.
• · Author technical reports and CMC sections of the regulatory dossiers (INDs, IMPDs, and NDAs etc.).
• · Manage the activities of formulation scientists at CDMOs focused on formulation and manufacturing process development.
• · Work effectively with CDMOs by providing technical oversight to ensure that Praxis’s formulation development and clinical manufacturing needs are met.

Qualifications and Key Success Factors

• · BS, MS, or PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry or related scientific field and 7+ years (12+ years for BS/MS) of industrial experience.
• · Experience in drug product formulation, manufacturing process development and scale-up.
• · Experience in leadership of interdisciplinary (Formulation) and multidisciplinary (CMC) teams
• · Strong fundamental understanding of physicochemical and biopharmaceutical properties and their importance in formulation design.
• · Experience in managing drug product activities at CDMOs
• · Strong communication, project management, and interpersonal skills.
• · Effective and innovative problem-solving skills
• · Able to work 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
• · 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. 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.

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
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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.