Manufacturing Associate II

Manufacturing Associate II, CGMP Manufacturing

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.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manufacturing Associate II, cGMP Manufacturing role. The 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 manufacturing facility.
• Observes and performs critical processing steps and provides real-time feedback.
• 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.
• Assists with the closure and/or reduction of deviations.
• 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.

Education and Experience

• A minimum of 2+ years of experience in a cGMP manufacturing environment along with a degree in science or a technical related discipline OR a minimum of 3+ 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.
• 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.
• Individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds.

The base salary range for this role is $61,500.00 - $76,900.00

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, in accordance with applicable law.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. 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.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. 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; 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.

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