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Director, Product Quality - Watertown, United States - Neumora
1 week ago
Description
The Director, Product Quality is responsible for managing GMP manufacturing, release, stability, and validation 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 batch disposition of drug substance, drug product, packaging, and labeling which will include review/approval of protocols, methods, reports, and related GMP source documents.
The Director, Product Quality also works collaboratively with Technical Operations for Drug Substance/Drug Product/Bottling/Labeling for conformance with cGMPs, Quality Control 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:
Support the management of the Batch Release Program.
Support the compliance oversight of manufacture and analysis of Drug Substance and Drug Products and packaging and labeling of clinical and commercial supplies at Contract Manufacturing Organizations (CMOs).
Review and approve Master Batch Record (MBR) in compliance with GMP regulations, and regulatory submissions.
Review and approve executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation ensuring batches as GMP compliant.
Perform data integrity and compliance assessments including review against source documentation for regulatory submissions (e.g., Module 3).
Support the internal Change Control, Deviation, and Quality Investigation systems.
Compile/archive MBRs, EBRS, and associated batch release documentation.
Maintain effective communication with CDMOs and deliver Quality objectives in accordance with project timelines.
Support Annual Product Review and Product Quality processes.
Support FAR/Withdrawal and Product Recall process.
Provide oversight of CMO/CTL inspection readiness (e.g., PAI).
Perform vendor audits both domestically and internally.
Qualifications:
B.S./M.S.
degree in analytical chemistry or related life sciences discipline with at least 15 years of quality assurance experience in pharmaceutical product development.
In-depth, working knowledge of cGMP compliance requirements for manufacturing and testing drug substance and drug product.
In-depth, working knowledge of the drug development process and ICH requirements related to CMC activities in support of NDA and MAA registration.
Capable of working 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.
Can follow procedures and perform assignments with a high degree of accuracy and careful attention to detail.
Willingness to travel (10%).
Preferred
Qualifications:
Other Compliance or Regulatory certifications (e.g., RAC, ASQ) a plus.
Experience auditing suppliers, CMOs, and CTLs.
Experience with Veeva is ideal.
Experience in small molecule pharmaceutical development and routine testing 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:
$185,008 - $200,655
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