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Bioprocessing Specialist

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 Bioprocessing Specialist participates in the hands-on production and other manufacturing efforts of Humacyte’s regenerative vessels.

This position reports to Director, Bioprocessing

Major Accountabilities:

  • Subject matter expert on processes and equipment and serves as a hands-on resource in Manufacturing Provides technical floor support to manufacturing operations
  • Authors and revises standard operating procedures and batch records
  • Ensures and executes processes according to standard operating procedures
  • Executes validation and qualification activities, as appropriate
  • Troubleshoots equipment related issues and develops sound engineering solutions to address identified problems
  • Leads non-conformance investigations to adequately identify root cause and implements appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis, investigation tools and methodologies. Implements corrective actions from investigations.
  • Identifies and implements continuous improvement projects to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls
  • Develops and maintains departmental metrics and key performance indicators (KPIs).
  • Provides training to other team members on major tasks and equipment
  • Responsible for scheduling manufacturing activities as well as coordinating equipment maintenance and validation, as needed
  • Responsible for coordinating activities to support manufacturing (i.e. raw materials and BPR issuance) as needed
  • Ensures manufacturing goals are achieved through robust safety practices and quality compliance
  • Serves as a back-up or assists as needed with daily activities required of vessel production
  • Leads improvement projects, as needed
  • Reviews design documents
  • Operates automated equipment
  • Completes a variety of atypical assignments, as needed
  • Ensures Humacyte or other required trainings/certifications are up-to-date
  • Other duties, as assigned

Special Competencies:

  • A solid understanding of basic engineering principles and the ability to apply knowledge
  • Excellent troubleshooting skills
  • The ability to work effectively in both a team environment and an individual contributor role
  • Works as a team player and serves as a model by participating in activities that involve cooperating with others
  • Applies functional and technical knowledge across a range of processes or operational procedures to deliver high quality work
  • Seeks out additional data from multiple perspectives to understand problems
  • Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically
  • Solid understanding of how related teams coordinate their efforts and resources to achieve objectives

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:

  • 5+ years previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required OR Bachelor’s degree in science related discipline with 3+ years’ industry experience
  • Demonstrated knowledge and experience with standard bioprocessing as well as use and maintenance of common laboratory procedures and equipment, required
  • Previous experience developing SOPs and documenting work, required
  • Basic mechanical aptitude or knowledge of electronic / mechanical equipment, preferred
  • Demonstrated knowledge of cGMP and FDA requirements, preferred
  • Working knowledge of cell culture principles, 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
  • Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
  • Position may require working holidays, weekends, etc.

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.**