Kyowa Kirin, Inc.- U.S. · 1 week ago
MSAT Engineer III
Sanford, NC
Full-time
Onsite
Mid, Senior Level
$106K/yr - $139K/yr
3+ 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 MS&T Engineer will provide technical leadership for the transfer, manufacturing, and testing of clinical and commercial drug substances, focusing on monoclonal antibody processes and ensuring operational readiness.
Pharmaceuticals
Responsibilities
Provide technical knowledge and insight, project management and leadership for the commercialization of mAb drug substances
Lead the transfer of drug substance processes to and from the manufacturing facility. Evaluate and optimize processes to improve efficiency and quality
Lead investigations and perform troubleshooting following process deviations, trends or issues. This includes designing and performing small-scale experiments/studies in lab to support technology transfer or investigations
Plan, conduct, and analyze DoE using appropriate statistical tools to drive process optimization and problem-solving
Create and implement corrective actions utilizing the site’s change control process
Collaborate and align with Global R&D and CMC, CDMOs, Process Engineering, Manufacturing, QA, QC to ensure processes are transferred and maintained effectively
Author and review technical reports, process transfer summaries and other documents. Review upstream and downstream manufacturing batch records and provide technical input to MFG technical document writing specialists
Maintain process databases and monitor batch-to batch consistency of operations. Support preparation of Continued Process Verification and Annual Product Reviews
Ensuring that changes to processes and methods are documented and carried out in compliance with cGMP requirements. Write change controls, perform impact assessment and collaborate with QA and manufacturing on establishment and execution of change action plan
Design, develop, and execute relevant project status and data reporting, lead discussions regarding investigations, and facilitate alignment in individual and group settings
Qualification
Required
BS, MS or PhD in Pharmaceutical Sciences, Physical Sciences, Engineering or related Life Sciences is required
BS with 5 years of experience, MS with 3 years of experience or PhD with 1+ years of experience with cell culture and purification in the biotech industry
Experience with Process Engineering, MS&T, Tech Transfer preferred
Experience with deviation, investigation, RCA and CAPA
Demonstrated project management skills
Excellent analytical and communication abilities
Good understanding of Good Manufacturing practices and applicable regulations (e.g. ICH regulations)
Skilled in operating bench-scale laboratory equipment for monoclonal antibody (mAb) process
Proficient in the use of MS Office Suite, as well as statistical analysis and the design of experiments (DoE)
Results-oriented and able to navigate ambiguity
Strong organizational skills, attention to detail, and a solid work ethic
Cultural sensitivity and the ability to foster alignment in a global environment
Ability to communicate with care by actively listening and considering others' perspectives
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
Preferred
Experience with starting up and operating a biopharma manufacturing facility is a plus
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
H1B Sponsorship
Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
2021 (1)
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
Company data provided by crunchbase