Qualifications
Responsibilities
Benefits
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Your Contributions (include, but are not limited to):· Recommends scientific and operational direction for assigned area and translates departmental strategy into tactical plans and team objectives.
· Leads analytical development activities across assigned programs/projects, including method development, qualification, validation, transfer, stability, and characterization.
· Provides technical leadership and recommends solutions to complex analytical development challenges.
· Oversees internal analytical activities and external CMO/CRO partnerships to support program timelines and deliverables.
· Partners with colleagues on the design, development, validation, and transfer of analytical methods for drug products.
· Contributes technical expertise to CMC regulatory dossiers and supports preparation and review of analytical sections for regulatory submissions.
· Evaluates analytical data, technical reports, and regulatory documentation to ensure scientific quality and compliance.
· Supports resource planning and prioritization for assigned activities in alignment with departmental objectives.
· Coaches and develops scientific staff and promotes a collaborative, accountable, and high-performing team environment.
· Other duties as assigned.
Common Knowledge & Skills
· Emerging internal scientific thought leader with strong technical expertise in analytical development.
· Applies in-depth scientific knowledge and critical thinking to resolve complex analytical development problems.
· Ability to translate established strategy and priorities into operational and tactical plans.
· Strong leadership, coaching, employee development, and influencing skills.
· Excellent written, verbal, presentation, problem-solving, and analytical skills.
· Ability to collaborate effectively across functions and within a matrix environment.
· Demonstrated ability to manage multiple projects, priorities, and external relationships.
· Learning agility and willingness to evaluate innovative scientific approaches and technologies.
Job-Specific Knowledge & Qualifications
· Strong knowledge of analytical method development, qualification, validation, transfer, and troubleshooting.
· Strong knowledge of ICH and FDA guidance related to analytical methods, stability, CTD, and CMC regulatory submissions.
· Experience evaluating analytical data, technical documents, and regulatory submissions.
· Knowledge of cGMP requirements and CMC regulatory expectations supporting drug substance and drug product development.
· Experience managing analytical activities with external CROs/CMOs.
· Knowledge of physicochemical characterization of APIs, drug substances, drug products, and related compounds.
· Understanding of formulation and process development and their relationship to analytical development.
· Previous people leadership and/or demonstrated leadership of scientific teams, projects, or external partners required.
Requirements:#LI-LS1
The annual base salary we reasonably expect to pay is $161,100.00-$220,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Our team will look into this right away.
