Manager, Vector Manufacturing Job at SK Pharmteco in King of Prussia

Company Overview
SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, The United States (CA and PA).  Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.

Position Summary
The Manager for Manufacturing will be responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks, Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).  Will also be responsible for performing activities within production facilities to support manufacture.

Primary Responsibilities

• Oversees the manufacturing process, oversees processing on the floor, and delegates daily work assignments.
• Lead, motivate, and develop manufacturing associates by promoting a culture of inclusiveness, safety, continuous improvement, training objectives, and compliance.
• Understands and performs aseptic technique and can identify unacceptable practices and make spot corrections to performance.
• Understands all operations, functions and capability of equipment and can perform complex troubleshooting.
• For escalations, work closely with the production staff to troubleshoot process and equipment problems.
• Maintains the Manufacturing facility and equipment to ensure constant compliance.
• Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues.
• Work closely with the production staff to troubleshoot process and equipment problems.
• Complete same-day review of completed batch records.
• Work with a cross-functional team of process development, engineering, MSAT, and quality teams for the development of cGMP-appropriate, scalable vector manufacturing processes and to ensure right-first-time technology transfer.
• Ensures work is completed in compliance with approved SOPs, batch records and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
• Review and approve SOPs, validation protocols, and reports related to process and equipment, as required.
• Works closely with Quality Assurance and MSAT in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
• Understands, trains and coaches others on all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshooting.
• Identifies, suggests with options, recommends path forward and leads complex decision-making sessions.
• Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end understanding.
• Oversees and adjusts training programs within the team, ensuring that manufacturing personnel are current on training requirements.
• Train manufacturing and other team members on manufacturing procedures & aseptic techniques, Quality systems and compliance, and other operations required for cGMP manufacturing operations.

Education & Experience

• Bachelor’s Degree in biological science(s) field or related engineering.
• Minimum 3 years of experience in cGMP biologic Manufacturing, Cell and Gene Therapy preferred.
• 1-2 years of leadership experience is preferred.
• Outstanding communication skills (verbal and written).
• Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word.
• Advanced knowledge of cGMP regulations.
• Working knowledge of GMP systems for: inventory management, asset management, sample management, quality management, and learning management.
• Advanced experience working with BSCs, incubators, centrifuges, cell counters, metabolite analyzers, RM bioreactors, single-use bioreactors, fixed-bed bioreactors, mixers, chromatography skids, hollow-fiber and/or flat-sheet TFF, Ultracentrifugation, Filling, and other GMP manufacturing equipment.
• Hands-on experience in scale-up and clinical/commercial scale manufacturing culture expansion, culture in various bioreactor designs, transfection, and related unit operations.
• Advanced ability to work well independently, as part of a team, and establish working interdepartmental relationships.
• Exhibits extreme attention to detail, accuracy in work, and integrity of character.
• Self-starter who shows eagerness to learn and problem-solve.
• Innovative and efficient when solving problems with a strong focus on continuous improvement.
• Possesses sound technical aptitude to learn and operate production equipment.
• Experience supervising, coaching, mentoring, and developing direct reports.
• Demonstrated ability to plan daily activities for self and team and resolve problems in area of expertise.
• Ability to lead and develop a team to accomplish individual and corporate goals.

• Must have the ability to gown in a clean room environment and apply required PPE for some period to perform audits, GEMBA walks, and tours.

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.
 

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