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.
The Manager, Quality Control is responsible for managing GMP Quality Control activities associated with development and commercialization of Neumora's small-molecule assets. This function operates within a virtual (100% outsourced) business model and will support site implementation of IPC and QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components, including method life cycle management (including method optimization), review/approval of protocols, methods, reports, batch records and related GMP source documents, oversight of stability operations, shelf life determination, reference standard management, and transfer/site implementation of analytical methods to support future supply chain expansion.
The Manager, Quality Control also works collaboratively with both Quality Assurance and Analytical Development to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
Key Responsibilities:
- Support the validation and implementation of IPC and QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.
- Perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data.
- Coordinate stability activities at CDMOs, compile/analyze stability data/reports and perform data trending.
- Support OOS/OOT investigations and other non-conforming investigations.
- Review/approve controlled GMP documents, e.g., analytical methods and associated validation protocols, reports, specifications, change controls, investigations, etc.
- Review development reports for data integrity and regulatory compliance; review CMC content incorporated into Module 3 sections of CTD regulatory submissions for translational accuracy.
- Compile/archive data packages, protocols, reports, methods, etc.
- Support effective communication with CDMOs and deliver QC objectives in accordance with project timelines.
Required Qualifications:
- B.S./M.S. degree in analytical chemistry or related life sciences discipline with at least 8 years of Quality Control experience in pharmaceutical product development.
- In-depth, working knowledge of cGMP compliance requirements for Quality Control laboratories.
- In-depth, working knowledge of the drug development process and ICH requirements related to CMC activities in support of NDA and MAA registration.
- Experience in CDMO management and cross-functional collaboration skills.
- Ability to work successfully in a team/matrix environment and independently, as required.
- Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
- Ability to convey both written and verbal information effectively and efficiently.
- Ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail.
Preferred Qualifications:
- Experience in small molecule pharmaceutical development and routine testing for solid oral dosage forms is desirable.
- Significant work experience ina virtual (100% outsourced) biopharmaceutical development business model is preferred.
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: $128,100- $138,398.
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.