Senior Director, Head of Analytical Development

Openkrill; United States; Remote; USD 250,000 - 275,000; Full time

Benefits offered by this job

Health benefits premium

Life insurance

AD&D

Disability benefits

401(k) match

Stock incentives

ESPP

Quarterly bonus

Wellness benefit

Generous PTO

Paid holidays & shutdowns

Job summary

Praxis Precision Medicines is seeking a Senior Director to lead Analytical Development for small molecules and oligonucleotides, defining scientific direction and building a high-performing team. You will drive method development, qualification, and lifecycle management, while coordinating with Development CMC, QA, Regulatory Affairs, and Clinical Supply to ensure readiness for IND/IMPD/NDA filings.

You will oversee external testing labs, ensure data integrity and GMP compliance, and contribute

Qualifications

• A Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field with 15+ years in pharma/biotech, or an MS/BS with commensurate experience.
• Experience developing/validating analytical methods and control strategies for drug substance/product across development to late-stage.
• Direct small molecule analytical development experience; ASO/siRNA analytics preferred.
• Proven track record authoring analytical CMC content for regulatory filings and health authority interactions.
• Experience directing CDMO/CRO relationships and outsourced testing; able to identify issues and resolve them.
• People leadership to build a technical team; strong communication across scientific, operational, and executive teams.
• Knowledge of ICH, USP/EP/JP, and GMP; CNS/rare disease development is a plus.

Responsibilities

• Set the analytical strategy for drug substance/product across portfolios and milestones.
• Lead method development, qualification, validation, transfer, and lifecycle management with QA, Process Development, and Regulatory.
• Prepare regulatory-ready analytical CMC content and represent analytical development with health authorities.
• Oversee CDMOs/CROs, method transfers, stability programs, and investigations of out-of-spec results; address risks early.
• Build and mentor a high-performing analytical team and define its structure as the portfolio grows.
• Collaborate with cross-functional teams to align analytical deliverables with program decisions and timelines.

Skills

Analytical leadership

Regulatory CMC knowledge

Method development

CDMO/CRO management

People leadership

Education

PhD in Analytical Chemistry or related field

MS/BS with commensurately greater experience

Tools

ICH guidelines

GMP compliance

Analytical method transfer

Job description

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

We are looking for a Senior Director to lead Analytical Development across our small molecule and oligonucleotide portfolios. You will set the scientific direction, build the team, and ensure our methods, specifications, stability programs, and control strategies are ready for each stage of development, from pre-IND work through potential NDA/MAA approval.

This is a hands-on leadership role in a growing, agile organization. You will make consequential technical decisions, work closely with colleagues across Development CMC, Quality, Regulatory Affairs, and Clinical Supply, and hold external partners to a high standard. Your work will help move promising molecules toward medicines for patients.

Primary Responsibilities

• Set the analytical strategy. Define and execute an approach for drug substance and drug product across the small molecule and oligonucleotide portfolios. Make clear choices about what each program needs now and what it will need at the next clinical or regulatory milestone.
• Build reliable methods and controls. Lead analytical method development, qualification, validation, transfer, and lifecycle management. Establish specifications, comparability approaches, and control strategies with Process Development, Quality, and Regulatory Affairs.
• Deliver regulatory-ready science. Author and review analytical CMC content for IND, IMPD/CTA, and NDA/MAA submissions. Represent Analytical Development in health authority interactions and explain the science clearly under scrutiny.
• Lead external execution. Oversee CDMOs, CROs, and contract testing laboratories, including method transfers, stability programs, and investigations of out-of-specification or out-of-trend results. Surface risks early and drive them to resolution.
• Build the function. Hire, coach, and develop a strong analytical team. Shape its structure and capabilities as the portfolio grows, while giving people clear ownership and direct, useful feedback.
• Connect the work to program decisions. Partner with Process Development, Formulation Development, Clinical Supply, Quality, Regulatory Affairs, and program teams so analytical deliverables support sound decisions and meet program timelines. Lead CMC teams and represent CMC function on cross functional program teams.
• Raise the standard. Champion data integrity, GMP compliance, and continuous improvement. Stay current with analytical technologies and regulatory expectations, and apply new approaches when they will improve the work.

Qualifications and Key Success Factors

• A Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field and 15+ years of relevant pharmaceutical or biotech experience; or an M.S./B.S. with commensurately greater experience.
• Deep experience developing and validating analytical methods and establishing control strategies for drug substance and drug product, from early development through late-stage or commercial readiness.
• Direct small molecule analytical development experience. Experience with ASO, siRNA, or other nucleic acid therapeutic analytics is strongly preferred.
• A record of authoring and defending analytical CMC content in regulatory filings and participating in health authority interactions.
• Experience directing CDMO/CRO relationships and outsourced analytical testing, with the judgment to identify issues and resolve them.
• People leadership experience and the ability to build a technical team in a growing organization.
• Strong working knowledge of ICH guidelines, USP/EP/JP compendial requirements, and current GMP regulations.
• Clear communication and sound judgment across scientific, operational, and executive discussions. Experience in CNS or rare disease development is a plus.
• An ownership mindset: you make your reasoning clear, invite candid feedback, challenge assumptions, and help others do their best work. You bring scientific rigor and urgency to decisions because patients are waiting.

At Praxis, our work is grounded in Trust, Ownership, Curiosity, and Results. We look for people who build with others, learn quickly, and follow through.

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 in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.Annualized Base Salary$250,000-$275,000 USD

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!

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 & InclusionGuided 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 orig