Associate Director, Analytical Development
Company
Neumora
Location
Remote
Type
Full Time
Job Description
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.
Neumora was listed as #1 on BioSpace’s NextGen Bio “Class of 2023,” top life sciences startups to watch!
We are seeking a talented individual to join our Analytical Development group in Brisbane, CA. The Associate Director, Analytical Development will supervise a variety of scientific functions encompassing small molecule drug substance and drug product development, and will provide day-to-day leadership for specific projects assigned. Profound knowledge of cGMPs and regulatory guidelines is required. Mentorship of junior technical staff is expected, with particular focus on method development and qualification/validation. The ability to work both independently and in a matrix team environment is essential. This role will report to the Director, Analytical Development.
Responsibilities:
- Oversees and coordinates CDMO’s analytical development activities to ensure the quality of products.
- Defines and develops specifications and test methods that are in compliance with applicable regulations and SOPs.
- Interfaces with CDMOs to develop/transfer methods and is a point of contact for investigations and other product development activities.
- Performs overall review of data generated on development and clinical supply samples; is the technical expert for data review and interpretation.
- Authors, reviews, and approves source documents for regulatory submissions.
- Authors, reviews, and approves SOPs, analytical methods, protocols, and reports.
- Mentors and supervises staff and is responsible for the quality and accuracy of the work done by others.
- Presents to cross-functional teams and effectively communicates critical issues and solutions to staff at all levels within the organization.
Qualifications:
- Â A PhDÂ or Master's in Analytical Chemistry or related field.
- 10+ years (PhD) or 13+ years (MS) within the Pharmaceutical Industry.
- Strong skills in Analytical Chemistry are required.
- Knowledge of cGMPs and Regulatory guidelines is a necessity.
- The ability to work successfully in both a team/matrix environment, as well as independently.
- The ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is critical.
- Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals.
- An in-depth knowledge of HPLC and GC, including both theory and practice.
- Knowledge of additional analytical techniques (MS, KF, dissolution) is also required.
- Must be able to travel 10% of the time.Â
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: $173,618 - $185,394
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#LI-Hybrid
Neumora Therapeutics, Inc. is a clinical-stage biotechnology company pioneering precision medicines for brain diseases through the integration of data science and neuroscience. Neumora is redefining neuroscience research and development with a data-driven precision neuroscience platform to cut through brain disease heterogeneity to match the right patient populations to targeted therapeutics. Neumora is relentless in its commitment to discovering, developing and commercializing targeted therapies for people living with 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.
Date Posted
05/23/2023
Views
9
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