Senior Manufacturing Associate

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist working from drug discovery to product development and North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.

As a Senior Manufacturing Associate supporting a greenfield biopharmaceutical site focused on rare disease therapies you will be responsible for starting up and executing core manufacturing operations. You will serve as a role model for safety and compliance executing complex upstream and downstream processes in a GMP environment. Your responsibilities will include contributing to troubleshooting and continuous improvement efforts ensuring compliance with regulatory standards and training and mentoring other manufacturing associates.

This role is highly collaborative involving close coordination with engineering automation and quality teams to help build a high-performing patient-centered manufacturing platform from the ground up. You will be hands-on in equipment commissioning process validation and the implementation of automated systems.

As an individual contributor you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment always acting in line with the organizations values. By using strong interpersonal skills you will work effectively with diverse viewpoints manage relationships thoughtfully and make decisions that meet both individual and team needs. You will be accountable for delivering results adapting to challenges and helping achieve business goals. Additionally you will take ownership of your tasks act with initiative and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

This role reports into the Manager Manufacturing

Technical Skills Knowledge and Experience
Execute manufacturing operations using standard work procedures for mAb production including weigh and dispense bioreactors filtration equipment inoculum preparation chromatography skids and UF/DF skids via PCS and MES.
Ensure all processes are performed in accordance with safety and compliance policies current Good Manufacturing Practices (cGMP) and applicable regulatory requirements including adherence to Data Integrity principles (ALCOA).
Follow operational procedures and master records ensuring a clear understanding of all requirements. Adhere to both written and verbal instructions provided by supervisors and seek clarification when needed to ensure compliance and accuracy.
Maintain accurate documentation including batch records log sheets and other required records.
Escalate all non-compliance events (perceived or actual) in a timely manner.
Collaborate with Process Engineering Automation CQV Quality OPEX and Warehouse teams to ensure compliant and efficient operations during commissioning and manufacturing.
Develop operational SOPs participate in FATs and support equipment validation and qualification in partnership with engineering teams.
Identify and implement process improvements to optimize manufacturing operations.
Propose and lead initiatives to streamline workflows and eliminate waste.
Stay current with industry trends and technologies to drive innovation in production planning.
Demonstrate proficiency in enterprise systems supporting manufacturing operations including but not limited to ERP LIMS MES PCS QMS and BMS.
Lead on-the-floor troubleshooting and resolution of equipment automation and process issues; actively support CAPA tracking and documentation.
Maintain cleanliness and organization of the manufacturing area through routine cleaning and preventive maintenance ensuring compliance with GMP and safety standards.
Manage the shop floor proactively using 5S standard work and Kanban methodologies.
Coordinate with warehouse and maintenance teams to ensure availability of materials supplies and equipment for uninterrupted production.
Partner with Manufacturing Managers to train new colleagues and junior staff on manufacturing processes equipment operation safety procedures and company standards to ensure team competency and adherence to best practices.
Actively support the technical transfer of new products and processes into the manufacturing area.
Individual contributor leading and coordinating task teams.

Education
Bachelors degree in a technical field (e.g. Chemical Engineering Chemistry Biology or related discipline) is preferred.

Experience
Bachelors degree with a minimum of 4 years of relevant experience in biopharmaceutical manufacturing.
Associate degree with a minimum of 6 years of relevant experience in biopharmaceutical manufacturing.
High school diploma or equivalent with a minimum of 8 years of relevant experience in biopharmaceutical manufacturing.
Experience in starting up and operating biopharmaceutical manufacturing processes is a plus.

Technical Skills
Experience with relevant unit operations including Upstream Downstream Inoculation and Weigh & Dispense.
Knowledge of Agile and Lean manufacturing principles including the use of Standard Work.
Experience in technical writing.
Proficient in Microsoft applications.
Strong problem-solving and critical thinking skills.
Experience in authoring or editing SOPs is a plus.
Proficiency in MES BMS and PCS software is a plus.
Maintains clean manufacturing environments in accordance with GMP and safety standards.
Ability to read and interpret technical documents troubleshoot issues and operate production equipment.
Ability to effectively comprehend written and verbal instructions.
Proficient in basic math statistics and English.

Non-Technical Skills
Results-oriented and able to navigate ambiguity you set clear outcomes track progress follow through on commitments and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly take accountability and manage tasks efficiently. Adapt to change with clarity patience and understanding guiding teams through evolving challenges. Exhibit strong organizational skills attention to detail and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others perspectives fostering productive engaging interactions and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect integrity and humility prioritizing collective success over individual gain. Resourceful and proactive challenge the status quo drive innovation and develop creative solutions. Apply an enterprise-wide holistic mindset working beyond siloed thinking to deliver cohesive integrated solutions.

This role will ultimately follow a 2-2-3 day shift schedule (7 a.m. 7 p.m.). However during construction and commissioning the position will operate on a MondayFriday day shift. Shifts will transition to 2-2-3 day shift schedule after commissioning.
Initially based on a construction site with transition to a biotech manufacturing facility in Sanford NC.
Ability to lift up to 35 lbs. and move heavy objects (e.g. material containers bagged product pallets of materials). Must be able to stand for 3 or more hours while operating equipment.
Maintain adherence to area gowning and task-specific PPE requirements.
This role is 100% on-site; it is not hybrid or remote.
Requires up to 10% domestic and international travel.
Additionally during the start-up phase this role may require training at our Takasaki Japan site for up to three months within the next two years.

The anticipated salary for this position will be $34 pr/hr to $51 pr/hr. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications job-based knowledge location and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America Inc. to provide equal employment opportunity to all qualified persons without regard to race religion creed color pregnancy sex age national origin disability genetic trait or predisposition veteran status marital status sexual orientation or affection preference or citizenship status or any other category protected by law.

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Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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