Senior Director, MS&T

KBI Biopharma, Inc.; Durham (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a Manufacturing Science and Technology Director/Senior Director to lead tech transfer, process validation and support lab activities.

You will supervise a multi-disciplinary team of engineers and scientists and collaborate with Process Development, Quality, Supply Chain, Facilities and Manufacturing to ensure timely, compliant execution. Key focus areas include Stage 2 PPQ through Stage 3 CPV, cGMP production, and continuous improvement of transfer

Qualifications

• BS/MS/PhD with extensive biologics experience and tech transfer expertise.
• Be able to lead cross-functional collaboration across sites.
• Understanding of cGMP, quality systems and process validation.

Responsibilities

• Direct tech transfer, process validation and lab support for MS&T.
• Lead multi-disciplinary projects and strategic oversight across sites.
• Manage resources, recruitment and performance in the department.

Skills

Tech transfer

Process validation

cGMP knowledge

Team leadership

Biologics processing

Education

Bachelor's degree in Science or Engineering

Master's degree in related field

PhD in related field

Job description

JOB SUMMARY

JOB SUMMARY The Manufacturing Science and Technology (MS&T) Director or Senior Director is responsible for establishing and directing the execution, resources, business processes and best practices for tech transfer, process validation, and support laboratory activities for the MS&T department at the Durham Patriot Park Manufacturing site. The Director or Senior Director will manage a multi-disciplinary team of Engineers and Scientists and will collaborate with Process Development, Quality, Supply Chain, Facilities, Engineering, and Manufacturing to ensure projects are executed efficiently and in a timely manner. The Director or Senior Director should demonstrate proven technical expertise in upstream or downstream biologics and have strong knowledge of industry best practices. The scope of this role includes: Drive new commercial product introduction and process validation from Stage 2 PPQ through Stage 3 CPV Process Validation and Pre-Approval Inspection (PAI) Drive new clinical product introduction to ensure successful tech transfer through collaboration with Process Development Establish and maintain the procedures, business processes and tools/systems for tech transfer to ensure that the business Drive standards and industry best practices to ensure organizational efforts are scalable and sustainable across sites Establish plans and strategies to ensure successful cGMP production by actively collaborating with manufacturing operations, quality and supply chain Drive activities of department resources to facilitate revenue growth and risk mitigation for manufacturing organization. Recruit and retain talent within organization. Represent the department during audits, client meetings and multi-disciplinary meetings with boards of health and upper management. Lead multi-disciplinary projects and strategic oversight for robust manufacturing operations, facility designs, new technology implementation, production revenue growth, cost of goods optimization and streamlined practices. Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promotion and disciplinary effort. Identify opportunities and provide the means for employees to pursue career growth.

JOB RESPONSIBILITIES

JOB RESPONSIBILITIES The candidate must apply sound judgment and effective decision making to drive the strategic objectives of the department and influence the broader business as a whole. In addition, the candidate is required to apply sound technical and management principles in order to drive tech transfer, process validation, process engineering and execution of support laboratory efforts and facilitate project execution and department performance within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to drive direction and have excellent communication skills in order to influence company objectives. Leads multi-disciplinary cross-functional projects Provides technical guidance to tech transfer, process validation, process engineering and laboratory efforts Oversees and maintains the procedures, business processes and tools for downstream tech transfer. Represents department in various technical and projects team meetings with client, board of health and upper management.

MINIMUM REQUIREMENTS

MINIMUM REQUIREMENTS BS in Science or Engineering with minimum of 18 years industry experience, Masters with 16 years industry experience or PhD with 14 years industry experience. Must have demonstrated biologics expertise in upstream or downstream processing and operations Must have experience in collaborating with process development, quality, supply chain, engineering and manufacturing. Demonstrated expertise in technical transfer, process validation, process engineering and optimization/scale up of biological processes is required Demonstrated knowledge of industry best practices, boards of health guidelines, cGMP compliance and engineering standards is required Experience with cGMP production operations is required Experience working in a cGMP manufacturing environment is a plus

EEO/AA Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

Employment Agreement

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Employee Profile & Opportunities

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.