Manager, Manufacturing Support

Kyowa Kirin North America•Sanford, NJ

21h•$118,100 - $154,200•Onsite

About The Position

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 commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. The Manager, Manufacturing Support will play a critical role in providing tactical direction and leadership for drug substance (DS) manufacturing at the new Kyowa Kirin North America monoclonal antibody (mAb) drug substance manufacturing facility in Sanford, NC. The manager will be responsible for solution & buffer manufacturing, weigh and dispense operations and material management. In addition they will backup manufacturing managers during batch operations. During the startup phase of the facility the Manager will provide leadership for our operational readiness program. They will work with all functional groups and our Tech Transfer Team to drive the program. They will provide project management leadership, develop plans, timelines, codependency’s, procedures, and implement curricula and learning plans. They will also be heavily involved with facility startup activities including digital systems, equipment and process validations as well as DS tech transfer activities. As a people leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization’s values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to address individual and team needs effectively. You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally, you will help teams navigate through change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset. This position will report directly to the Director, Manufacturing in Sanford, NC.

Requirements

AS or BS in Physical Sciences, Engineering or related Life Sciences is required
Minimum 7 years of experience + Associate’s degree OR minimum 5 years of experience + Bachelor’s Degree
Relevant pharmaceutical DS manufacturing experience preferred
Experience with implementing Lean Manufacturing
Demonstrated leadership and teamwork skills
Excellent analytical and communication abilities
Good understanding of process validation concepts and experience with technical transfer preferred
Proficiency with ERP systems such as MS Dynamics 365
Proficient in MS Office Suite
Proficient in statistics
Proficiency with Document Management and Investigation generation (e.g. in Veeva) as well as Change Control
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.
Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC. Work is 100% on-site. This is not a hybrid or remote role.
Requires up to 10% domestic and limited international travel

Nice To Haves

Experience with starting up and operating a biopharma manufacturing facility is a plus.

Responsibilities

Provide project and program management expertise during the initial design and construction phase of the project.
Have a thorough understanding of manufacturing and its management via Standard Work.
Hiring, training, and develop a team of operators and other individual contributors.
Deliver on KPI’s and communicate KPIs and batch status at Tier meetings. Escalate issues that cannot be resolved within the process centric team.
Use the Continuous Improvement loop to identify related issues. Work with Process Engineers, MS&T, Maintenance and QA in the process centric team to resolve these issues. Utilize Kaizen events to improve operational efficiency.
Oversee the planning, procurement, storage, and distribution of materials to ensure production needs are met cost-effectively and efficiently. This includes preparation of buffers and solutions to meet demand.
Understand and be able to implement Lean Manufacturing principles such as TPM to maintain process equipment in a compliant manner.
Be the subject matter expert on the manufacturing process providing technical knowledge, oversight and leadership for the manufacture of mAb DS.
Author and review SOP’s and Work Instructions to facilitate DS manufacturing.
Ensures all processes are performed in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+), as well as all other applicable regulatory requirements. Ensuring that the facility is inspection ready every day via Gemba walks, use of 5S and Standard Work.
Lead teams by setting clear, measurable goals and ensuring accountability for achieving key objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within set timelines.
Listen carefully, give helpful feedback, and handle conflicts with care.
Mentor and guide team members, create growth plans, support ongoing learning, and develop the team with a patient-focused mindset.
Build a diverse, respectful environment where everyone feels valued and supported.
Encourage a positive workplace, celebrate achievements, and promote work-life balance.
Lead by example, promote teamwork and respect, and ensure your actions reflect the organization’s values.
Manage emotions thoughtfully, make empathetic decisions with a patient-focused mindset, and stay calm under pressure.
Help teams navigate change with clear communication and flexibility.
Adapt your leadership style to meet the needs of the team, offering guidance or independence as needed, while keeping patient outcomes in mind.
Work with different people to build alignment, guide discussions toward common goals, and ensure decisions are aligned with a patient-focused mindset.

Benefits

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 Incentive Program (subject to job level and performance)
Life & Disability Insurance
Concierge Service
Pet Insurance
Tuition Assistance
Employee Referral Awards