At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.
This role will lead the analytical development of multiple small molecule drug candidates from clinical development through commercialization.
Responsibilities:
- Serve as the technical and strategic expert in analytical method development for product attributes of small molecule therapies.
- Establish and manage work plans to achieve analytical development goals across all products.
- Establish product characterization, comparability strategies and plans in compliance with regulatory requirements.
- Represent Analytical Sciences in cross-organizational governance and committees to drive and steer technical and business strategies and processes.
- Lead product characterization, CQA assessment, method development/optimization, setting scientifically justifiable comparability strategies, specification and control strategies.
- Provide technical and GMP compliance guidance to cross-functional teams in support of project goals.
- Provide technical leadership and subject matter expertise relating to product investigations.
- Represent the analytical development function for authoring, reviewing, and approval of GMP and regulatory documents as appropriate, including SOPs, protocols, reports, specifications, QTPPs, CQAs, risk and impact assessment, and filing sections.
- Lead cross-functional team to develop business processes and guidelines for coordinated early and late-stage analytical development activities in support of clinical development and commercialization.
Qualifications:
- PhD in synthetic Organic Chemistry, Analytical Chemistry with 15 + years of relevant experience in the pharmaceutical industry.
- Strong knowledge of synthetic organic chemistry and the ability to communicate effectively with chemical development and manufacturing teams.
- Good understanding of different organic functional groups and organic terminology.
- Significant and established experience in late-stage product characterization, regulatory filing, and response to agency questions.
- Demonstrated organizational and strategic leadership in establishing technical guidelines and business processes, as well as steering cross-organizational alignment.
- Solid understanding of innovative physicochemical characterization technologies.
- Team oriented and able to lead multiple projects across various development stages.
- Experience interacting with chemical development, manufacturing, formulation, lot release/stability, Quality and Regulatory functions, to ensure strong cross-functional collaborations and coordinated process and product development.
- Experience working with business partners across global development and manufacturing network.
- Good understanding of quality systems and experience with successful internal and regulatory audits/inspections.
- General and scientific computer and software application proficiency.
Company benefits include:
- Medical, dental, vision, and life insurance
- 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
- New hire stock options
- Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
- Leave of Absence: Paid family leave, paid short- and long-term disability
- Discretionary year-end bonus
The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $244,860 - $256,944
Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.
Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.