QC Microbiology Associate 2

Humacyte, Inc. is proud to be a vaccinated workplace where all employees are expected to be fully vaccinated against COVID-19. Proof of full vaccination is required before beginning work. Humacyte will provide accommodations as required by law.

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 QC Microbiology Associate 2 will perform environmental monitoring (EM) sampling within classified areas of the facility. Compile data collected from EM program for quarterly trend reports. Participate in performing periodic gown qualifications, nonconformance events and implementation of corrective and preventative actions as needed.

This position reports to Manager, QC Microbiology

Remote Work Designation: Not Remote

Primary Responsibilities:

• With direction from lead or supervisor and with limited supervision, perform environmental monitoring sampling (total air particulate, viable surface and air) within classified areas of the facility
• Participate in the collection of personnel monitoring samples for periodic gowning qualifications
• With direction from lead or supervisor and with limited supervision, perform Bioburden and Endotoxin testing on in-process and finished product samples
• With direction from lead or supervisor and with limited supervision, perform media qualification testing on incoming microbiological growth media, sterile rinses and diluents
• Compile data for quarterly and annual Environmental Monitoring trending reports
• Participate in nonconformance events and implementation of corrective and preventative actions
• Participate in drafting Environmental Monitoring and Gas trending reports as well as validation protocols
• Help coordinates sampling and testing schedule
• Qualified trainer on specific processes within QC Microbiology and critical equipment
• Assist in authoring and revising standard operating procedures and protocols
• Assist in managing and purchasing of laboratory consumables
• Support the Quality Control raw material release program, as required Other duties, as assigned

General Competencies:

• Possess a positive 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
• Strong communication (verbal and written) and organizational skills
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Detail-oriented, self-motivated and scientifically driven
• Motivated and organized critical thinker with solid interpersonal and communication skills
• Strong analytical and problem-solving skills
• Demonstrated ability to work in a cross functional team
• Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
• Must be able to work as needed to meet tight deadlines and at peak periods

Special Competencies:

• Ability to read and understand compendial guidance documents for microbiological applications, including United States Pharmacopoeia, European Pharmacopoeia, and Japanese Pharmacopoeia
• Ability to read, understand, and follow all applicable company policies and standard operating procedures
• Ability to gown for entry into controlled environment manufacturing areas
• Basic knowledge and understanding of current Good Manufacturing Practices
• Familiarity with standard laboratory equipment and instruments
• Effective and timely communication of atypical, aberrant, and out-of-specification test results
• Ability to recognize and report standard operating procedure deviations

Qualifications

• Bachelor's degree, required. In Microbiology, Biology, Biochemistry or similar field, preferred
• 2-4 years of relevant experience and/or training
• Or equivalent combination of education and experience
• Will spend time in a clean room environment for QC responsibilities 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 and over-time

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.**