Manager, Quality Control

Neumora was listed as #1 on BioSpace’s NextGen Bio “Class of 2023,” top life sciences startups to watch!

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 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 and 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.

Responsibilities:

• Review method development reports and feasibility and evaluate suitability of methods for validation.
• Support the validation 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/archiving data packages, protocols, reports, methods etc.
• Support cGMP audits of CDMO laboratories.
• Support effective communication with CDMOs and deliver QC objectives in accordance with project timelines.

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.
• Experience in small molecule pharmaceutical development for solid oral dosage forms is desirable.
• Significant work experience in a 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: $117,600 - $130,000

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