[ref. y15199622] Sr. Manufacturing Associate, cGMP Manufacturing
Sumitovant Biopharma Morrisville
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based inJapanwith key operations in the U.S. (Sumitomo Pharma America, Inc.),Canada(Sumitomo Pharma Canada, Inc.) andEurope(Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies.
With several marketed products in the U.S.,Canada, andEurope, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.
This position will be onsite at the manufacturing facility in Morrisville, NC. This position is a non-exempt role and will operate on one of two shifts following a 2-2-3 schedule with the following hours: 7:00am-7:30pm on workdays that occur Sunday through Thursday and 7:00am-5:30pm on workdays that occur on Fridays and Saturdays.
Observes and performs critical processing steps and provides real-time feedback.
Develop a Subject Matter Expert (SME) level understanding of SMPA CPC GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
Create, redlines, and reviews process Standard Operating Procedures (SOPs).
Develop a suitable level understanding of Sumitomo Pharma America, Inc.
GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
Performs inventory control and cycle counts. Resolves and reports issues with product accountability and inventory system discrepancies.
Executes real-time batch record review. Performs alarm monitoring and reconciliation.
Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the production floor.
Collaborates with stakeholders and customers to resolve production-related issues.
Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.
Serves on safety, quality, and other committees, if applicable.
Attends and actively participates in waste walkthroughs, 5S, kaizen events, lean six-sigma, quality, safety, or environmental training/initiatives, as required.
Develop a Subject Matter Expert (SME) level understanding of Sumitomo Pharma America, Inc.s GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
Coaches, supervises, owns, and assists with the closure and/or reduction of quality events.
Own small CAPA projects related to process improvements.
Maintains training status and trains new team members.
Strong attention to detail.
Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively.
Ability to work safely and conscientiously in a manufacturing environment.
Ability to identify and addresses compliance, environmental, safety, and process deviations as required and escalates to appropriate personnel.
Leads tasks to completion.
Prior experience supporting new facility start-up and validation preferred.
Experience in aseptic operations required.
Scientific and or engineering knowledge attained through a degree or certificate program is preferred but not required.
Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.
Background in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations is strongly desired
Experience with batch record execution, including good documentation practices.
Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.
Our robust time-off policy includes up to 120 hours of vacation per year, 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 and access to our service recognition program.
With several marketed products in the U.S.,Canada, andEurope, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.
For more information on SMPA, visit our (link removed)or follow us onLinkedIn.
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Sr Manufacturing Associate, cGMP Manufacturing role. The Sr Manufacturing Associate will support facility start-up activities and will be responsible for producing regenerative medicines.This position will be onsite at the manufacturing facility in Morrisville, NC. This position is a non-exempt role and will operate on one of two shifts following a 2-2-3 schedule with the following hours: 7:00am-7:30pm on workdays that occur Sunday through Thursday and 7:00am-5:30pm on workdays that occur on Fridays and Saturdays.
Weekends and holidays are required as scheduled.
Job Duties and Responsibilities
Participate in process validation activities for Sumitomo Pharma America, Inc. new multi-product facility.Observes and performs critical processing steps and provides real-time feedback.
Develop a Subject Matter Expert (SME) level understanding of SMPA CPC GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
Create, redlines, and reviews process Standard Operating Procedures (SOPs).
Develop a suitable level understanding of Sumitomo Pharma America, Inc.
GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
Performs inventory control and cycle counts. Resolves and reports issues with product accountability and inventory system discrepancies.
Executes real-time batch record review. Performs alarm monitoring and reconciliation.
Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the production floor.
Collaborates with stakeholders and customers to resolve production-related issues.
Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.
Serves on safety, quality, and other committees, if applicable.
Attends and actively participates in waste walkthroughs, 5S, kaizen events, lean six-sigma, quality, safety, or environmental training/initiatives, as required.
Develop a Subject Matter Expert (SME) level understanding of Sumitomo Pharma America, Inc.s GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.
Coaches, supervises, owns, and assists with the closure and/or reduction of quality events.
Own small CAPA projects related to process improvements.
Maintains training status and trains new team members.
Performs other activities as required.
Key Core Competencies
Build strong, open, and collaborative working relationships with both internal and external stakeholders.Strong attention to detail.
Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively.
Ability to work safely and conscientiously in a manufacturing environment.
Ability to identify and addresses compliance, environmental, safety, and process deviations as required and escalates to appropriate personnel.
Leads tasks to completion.
Demonstrated leadership ability preferred.
Education and Experience
A minimum of 3+ years of experience in a cGMP manufacturing environment along with a degree in science or a technical related discipline OR a minimum of 5+ years of cGMP manufacturing experience with a high school diploma is required.Prior experience supporting new facility start-up and validation preferred.
Experience in aseptic operations required.
Scientific and or engineering knowledge attained through a degree or certificate program is preferred but not required.
Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.
Background in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations is strongly desired
Experience with batch record execution, including good documentation practices.
Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.
Individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds.
The base salary range for this role is $69,700 to $87,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, 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 up to 120 hours of vacation per year, 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 and access to our service recognition program.
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.
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.
Confidential Data- All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
- 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.
- 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
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