Manufacturing Technical Operations III

The Manufacturing Technical Operations III provides basic to advanced technical support for the manufacturing process and is a key liaison between the manufacturing and Humacyte MSAT teams. 

Remote Work Designation: Onsite/Not Remote

  Major Accountabilities:

Performs moderate to advanced scope processes and serves as a hands-on resource in Manufacturing Humacyte’s regenerative vessels by:

• Provides daily technical floor support for clinical or commercial manufacturing operations.
• Utilizes advanced process knowledge to identify and provide primary response to manufacturing events and ensures troubleshooting support for challenges identified.
• Interfaces and acts as liaison between Manufacturing Operations and Manufacturing Science and Technology teams.
• Performs deviation management support, including initiation, impact assessment, and investigation ownership as needed.
• Performs daily activities required of vessel production as needed to support peaks in production volume. 
• Leads change control or small to mid-scale projects.
• Provides compliance review and/or approval for relevant GMP documents, deviations, CAPAs, change controls, SOPs as needed.
• Recognizes and solves typical and atypical problems that occur in own work area without supervisory approval.
• Supports projects of moderate to large scope (e.g. operational excellence, safety). 
• Supports the collection and tracking of area metrics and process control data.
• Ensures process steps are executed according to defined SOPs and BPRs and partners with team members to ensure understanding and accuracy.
• Ensures thorough and proper documentation of activities in accordance with cGMPs. 
• Adheres to the proper handling of chemically hazardous goods.
• Interfaces with process automation and electronic business systems. 
• Supports, and may lead, the revisions of SOPs and BPRs.
• Supports, and may lead, qualifications and validation activities, as assigned.
• In collaboration with Bioprocessing leadership, recognizes, troubleshoots, and initiates deviations for process issues of moderate scope.
• Supports team effort in the effective and timely completion of root cause investigations and CAPA implementation.
• Provides continuous training of other team members on standard roles as needed.
• Ensures Humacyte or other required trainings/certifications are up to date.
• Other duties, as assigned.

Special Skills:

• Works within clearly defined standard operating procedures (SOPs) and/or scientific methods.
• Uses advanced knowledge of cGMP manufacturing, Humacyte’s manufacturing process, analytical skills, and application of scientific methods or operational processes to perform a variety of activities.
• Provides recommended solutions and steps for resolution to problems of moderate complexity to leadership.
• Identifies areas or situations with greater complexity and partners with the Humacyte MSAT team to ensure appropriate resolution.
• Possesses deep and strong technical skills and the ability to translate those technical skills into problem solving and solutions.
• Has ability to differentiate between important and less important tasks within own work and act accordingly.
• Strong, proactive communicator that is able to interface effectively across multiple departments with support as needed.

Qualifications:

• Requires a Bachelor’s Degree, or equivalent on the job experience.   Master’s degree or above preferred.
• 5+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required.
• Strong knowledge of cGMP requirements, required.
• Experience executing SOPs and demonstrated thorough and strong documenting work, required.
• Moderate to advanced mechanical aptitude or knowledge of electrical / mechanical equipment, preferred.
• Previous cell culture experience, highly preferred.
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.

 General Competencies:

• Able to communicate effectively in English, both verbally and in writing
• Excellent communication and interpersonal skills
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross-functional team environment
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Ensures Humacyte or other required trainings/certifications are up to date
• Represents the organization in a positive and professional manner

Reports to work on time and as scheduled