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MSAT Engineer 3

All Openings | Research Triangle Park, NC | Full Time

Job Description

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 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 colleagues to continue to build our expanding 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 lead other professionals and peers.

Position Background:

The MSAT Engineer 3 will support upstream cell expansion (2D) processes with limited supervision and guidance. This role will collaborate effectively with personnel in Process Development, Manufacturing, Engineering, Quality Assurance, and Quality Control and utilize strong communication, technical expertise and influencing skills to generate optimal results. The role will be the primary cell expansion SME supporting manufacturing and represent MSAT in project teams and troubleshooting activities.

This position reports to Director, MSAT.

Major Accountabilities:

  • Provide oversight and accountability for technology transfer and process validation of products into commercial manufacturing facility
  • Collaborate with personnel in Process Development, Manufacturing, Engineering, Quality Assurance and Quality Control on process improvement. Provide leadership in developing process improvement priorities
  • Process expert on the upstream cell expansion, single use bioreactor control and optimization. Experienced with cGMP cell banking. Mentor junior staff in developing process knowledge and expertise
  • Provides advanced level support execution and development of the Humacyte’s upstream cell expansion process (referred to as 2D) other functions as needed. In-depth experience with process automation/DCS and the use of a data historian strongly preferred
  • Maintain and report process run summaries and continued process verification reports
  • Prepare and present data associated with manufacturing processes
  • Maintenance of Process Control Strategy
  • Collaboratively supports troubleshooting, non-conformance investigation, and change control management activities utilizing advanced engineering concepts and data analytics/trending
  • Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains. Serve as the key project designee responsible for identifying new technologies set to improve manufacturing capabilities
  • Other duties, as assigned

Special Competencies:

  • Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations
  • Able to lead development of solutions and implementation of process improvements to manufacturing issues by way of corrective and preventative actions (CAPAs)
  • Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Development, Engineering, QA, QC, etc.)
  • Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products
  • Ability to provide technical training to others on GMP manufacturing operations
  • Advanced technical understanding of cell and tissue-based products; strong understanding of cGMP manufacturing and US/EU regulations
  • Demonstrated expertise with operation, control and optimization of single use bioreactors. Experience with scale-up/scale-out of bioreactor-based processes
  • Possess exceptional analytical problem-solving skills, including the ability to drive the resolution of complex issues where analysis of events or data requires an in-depth knowledge of process and equipment performance
  • Understand and interpret all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis and identify applications where appropriate

General Competencies:

  • Able to communicate effectively in English, both verbally and in writing

  • Possess a positive roll-up-the-sleeves attitude and optimistic outlook

  • Represents the organization in a positive and professional manner

  • 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

  • Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements

  • Always observe safety precautions and regulations in all areas where duties are performed

  • Responsible for reporting all safety hazards and potential unsafe working conditions

  • Reports to work on time and as scheduled

QUALIFICATIONS:

  • BS in Biochemistry, Chemistry, Biology or other relevant discipline required; MS in related discipline preferred
  • Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, process development
  • 5-8 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience
  • Possess a demonstrated technical foundation of cell- and tissue- based products and proficiency with GMP manufacturing
  • Demonstrated ability to build effective working relationships across departments (QA, Process Development, Project Management and Business Development) to support new processes and products
  • Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
  • Experience with cell culture and upstream bioprocessing, experience with adherent mammalian cells, preferred
  • Strong scientific and technical experience performing upstream bioprocessing activities involving seed train, media optimization, cell line development/banking, and experience with automated single use bioprocessing systems

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 12 Paid Holidays
  • Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**