Kyowa Kirin, Inc.- U.S. · 1 day ago
Manager, Manufacturing Support
Sanford, NC
Full-time
Onsite
Mid, Senior Level
$118K/yr - $154K/yr
5+ years expKyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The Manager, Manufacturing Support will provide tactical direction and leadership for drug substance manufacturing at the new facility, overseeing operations and ensuring readiness during the startup phase.
Pharmaceuticals
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
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
Qualification
Required
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
Experience with starting up and operating a biopharma manufacturing facility is a plus
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
Preferred
Relevant pharmaceutical DS manufacturing experience
Good understanding of process validation concepts and experience with technical transfer
Experience with starting up and operating a biopharma manufacturing facility
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
Company
Kyowa Kirin, Inc.- U.S.
Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Ana Bastiani-Posner, MBA
Executive Vice President & Chief Financial Officer
Tara D'Orsi
Executive Vice President, Chief Compliance Officer and General Counsel at Kyowa Kirin North America
Recent News
Business Journals
2024-03-08
2024-03-03
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