Manufacturing Manager – cGMP Manufacturing

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

We seek a dynamic, highly motivated, and experienced individual for the Manufacturing Manager, cGMP Manufacturing role.  The Manufacturing Manager will ensure production readiness and compliance initiatives are optimized and executed appropriately in GMP production. This position will be onsite at the manufacturing facility in Morrisville, NC.  This position is an 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 

• Hire and develop a high-performing, flexible manufacturing team (approximately 5 operators) capable of meeting the manufacturing operation timeline.  

• Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized for training and to manufacture RETHYMIC and future clinical programs for on time delivery.  

• Oversee the training, development, retention, and performance of staff for the execution of manufacturing operations.  

• Closely partner with QA peers for creation of SOPs, closure of documentation, inclusive of training records, deviations, batch records and CAPAs, required for timely disposition of batches.  

• Ensure smooth production operations through proactive scheduling and planning of activities.  

• Lead efforts in scheduling personnel for follow-up and emergency production work.  

• Responsible for ensuring alarm monitoring, response, and reconciliation is performed in a timely fashion.  

• Attend and actively participate in waste walkthroughs, 5S, Gemba walkthroughs, kaizen events, or any other operations, lean six-sigma, quality, safety, or environmental training/initiatives, as required.  

• Coach operators in high quality deviation write-ups and appropriate CAPA development/effectiveness checks; drives manufacturing deviations to on-time closure and works with team to assure minimal deviations.  

• Support regular operation of manufacturing facility and responds to issues as needed.  

• Prepare for and successfully participate in internal audits and FDA inspections.  

• Prioritizes the work of others.  

• Performs other activities as required. 

Key Core Competencies 

• Clear communication is required with cross-functional peers daily.  

• Ability to build strong, open, collaborative working relationships with internal and external stakeholders.  

• Sound knowledge of current Good Manufacturing Practices.  

• Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation, and initiative required.  

• Strong oral/written technical communication and leadership skills are required.  

• Ability to work well with all levels of company personnel.  

• Ability to work independently with minimal supervision.  

• Capable of rapidly absorbing technical data and applying this knowledge to a pharmaceutical manufacturing environment.  

• Problem-solving experience providing consistent judgment, quality, accuracy, speed, and creativity.  

• Takes initiative in making improvement suggestions to promote operational goals.

Education and Experience

• A minimum of 5 years of relevant experience working in the pharmaceutical, biopharmaceutical, regenerative medicine, or medical device industry is required.  

• Minimum 2 years of management or cross-functional project management experience in a professional setting.

• Previous experience working in ISO 7 & 8 cleanrooms along with isolators is preferred. 

• Experience at an FDA approved or late-stage cGMP manufacturing site. 

• Experience in production batch record review, investigation of deviations, root cause analysis, effective CAPA development, good documentation practices, and change control management.

• Experience delivering consistently prompt, efficient, dependable, highly skilled service to multiple stakeholders.

• Bachelor's degree in science or engineering, or a degree in a relevant technical trade, is required.

• Background in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations is strongly desired.

Travel Requirements:

Employees based onsite may need to travel domestically and/or internationally up to 10-25% of the time as required. Additional travel may be required for Management roles.

Mental/Physical Requirements:

1. Lifting and Carrying: Ability to lift and carry materials, including heavy items, as part of daily operations.

2. Standing and Walking: Prolonged periods of standing and walking

3. Manual Dexterity: Handling and operating equipment and tools.

4. Climbing and Reaching: Ability to climb ladders or steps and reach for items stored at various heights.

5. Environmental Conditions: Working in varying temperatures and handling materials in different environmental conditions.

The base salary range for this role is

$120,000.00 - $150,000.00

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 flexible 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.

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.

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.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.