Manufacturing Technical Operations III

Position Profile

Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.

We are looking for additional technically strong colleagues with intellectual curiosity, and a solutions focused mindset with the proven ability to solve problems from simple to complex to expand our team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and partner effectively with other professionals and peers.

Position Background:

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

Highlighted Perks & Benefits:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Strong and competitive Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO) to start
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**