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Karuna Therapeutics is Hiring a Quality Assurance, CMC (Manager-Senior Manager) Near Boston, MA
Position Summary
Karuna is seeking an experienced and motivated individual to join our Quality Assurance team as Manager/Senior Manager, CMC Quality Assurance, to support drug development from Phase 1 to commercialization. Reporting to our Senior Manager, Quality Assurance CMC, this position is responsible for managing, reviewing, and approving quality documents from Contract Manufacturing Organizations and Contract Testing Laboratories for manufacturing, testing, validation, and disposition of clinical and commercial products for human use. This position will work closely with CMC Analytical Development and CMC Quality Control, Regulatory Affairs, and other functional teams.
Responsibilities
- Ensures compliance to cGMP policies and procedures for documentation resulting from manufacturing operations of clinical and commercial small molecule API and drug product.
- Provides Quality Assurance oversight of analytical development and QC activities, including method validation, method transfers, and reference standard qualifications.
- Performs assessments and QA review of Change Controls, deviations, root cause analyses, and product impact assessments and investigations, including OOS investigations, for commercial and clinical products.
- Reviews product release and stability data.
- Provides Quality oversight of protocols, starting material and finished product specifications, API and DP manufacturing documentation, and analytical and stability reports.
- Ensures corporate readiness towards regulatory CMC inspections.
- Ensures data integrity in GMP documentation from manufacturing, and analytical and stability studies.
- Supports disposition activities for manufactured products in support of Commercial/Clinical Product, including Master Batch Record review, Executed Batch Record review, resolution of comments/issues and Certificate of Analysis review.
- Supports other QA operation or compliance activities as needed.
- BS/BA in Chemistry, Biology, Pharmaceutics, or other science-related field.
- 5-8 years of experience within the pharmaceutical industry and in a GMP role. Laboratory and QA experience is strongly preferred.
- Knowledge of FDA, EU, ICH requirements for GMP and related areas (e.g., 21 CFR 211, Part 11 / Annex 11, ICH Q7 etc.).
- Experience in reviewing Specifications, MBRs, EBRs, stability protocols, method validation protocols and reports etc.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Attention to detail and quality are critical to success.
- Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
- Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
- Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
- Forward thinking mindset with the ability to manage multiple projects and identify and resolve issues.
- Broad experience in an emerging, publicly traded company environment is a plus.
Our purpose is to create value for those we have the privilege to serve:
- We take pride in our work
- We keep our promises and deliver
- We are driven to meaningfully innovate
- We succeed through inclusion and teamwork
#LI-Hybrid
Job Summary
Full Time
$121k-152k (estimate)
04/20/2024
05/06/2024
karunatx.com
BOSTON, MA
50 - 100
2009
STEVEN PAUL
$10M - $50M
Pharmaceutical
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About Karuna Therapeutics
We are a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients as they navigate the challenges presented by these complex conditions. Weve made it our mission to use our extensive knowledge of the patient journey and neuroscience to develop novel medicines with the potential to provide meaningful differences in peoples lives. Our shared passion inspires us to collectively work to ...
ward a goal bigger than ourselves, and our team is motivated to responsibly study and deliver medicines that can offer substantial improvements to those living with schizophrenia, dementia-related psychosis, and other psychiatric and neurological conditions.
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