Manager, Quality Control
- Employer
- Sumitomo Pharma America
- Location
- Morrisville, NC
- Start date
- Sep 17, 2023
View more categoriesView less categories
- Discipline
- Quality, Quality Control
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
Job Title
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com]
Job OverviewWe are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, Quality Control. We are looking for a Manager, Quality Control to join our team and support our Quality Control functions. The ideal candidate will be dedicated to excellence and high performance, passionate, innovative, and eager to work in a collaborative environment. A demonstrated track record of success in quality control testing in support of Biologics is expected; experience in contributing to starting up a new quality control laboratory of a commercial manufacturing facility is a plus. Importantly, we seek an aspiring professional with potential and desire to grow within the company.
The successful candidate will be an integral member of a growing Quality Control team and work closely with a cross-functional development team and external partners. Critical roles include supporting qualification of laboratory instruments and methods. This critical role will report to the Associate Director of Quality Control.
Job Duties and Responsibilities
- Author and review laboratory SOPs, protocols and other documents required to establish the new QC laboratory and related processes.
- Execute the transfer, verification, and validation of methods.
- Support routine raw material, in-process, and finished product release testing.
- Coordinate incoming material and external laboratory testing.
- Perform/ support laboratory investigations.
- Ensure the integrity and delivery of accurate and timely data to support development and release of investigational and commercial products.
Key Core Competencies
- Experience with validating and executing qPCR, ELISA, and other biological assays.
- Proficiency in drug product and raw material release and stability testing for Biologics.
Strong working knowledge of Industry Compendia, regulations, and standards, including USP / Ph. Eur, GMP, FDA/EMA, and ICH
Education and Experience
- Minimum 6 – 8 years (w/o Master’s) or 4 – 6 years (with Master’s) of relevant experience in biotech or pharmaceutical industry
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
The base salary range for this role is $87,000 - $120,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Confidential Data:All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW
EEO is the Law Poster Supplement
Confidential Data:All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW
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