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Director, MSAT

All Openings | Research Triangle Park, NC | Full Time

Job Description

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

Humacyte is a late stage clinical biotech company developing a first in class tissue engineered human acellular blood vessel (HAV) to address multiple unmet needs in vascular repair and reconstruction. Humacyte’s manufacturing process combines advanced upstream bioprocessing technology and novel, automated production systems.

The Director, MSAT will execute a critical role in supporting the licensure of the HAV product as well as the initiation and subsequent expansion of commercial manufacturing operations at Humacyte’s Durham, NC headquarters.

The Director, MSAT will be expected to work both independently and collaboratively as part of the Humacyte organization. Candidates must be highly self-motivated, with exceptional communication skills, and demonstrated ability to work in a fast-paced team environment. This position is an integral component of Humacyte’s commercial manufacturing leadership team.

Position Background:

The successful candidate will work with the Process Development, Automation, Bioprocessing and Quality teams to implement robust cell-based manufacturing processes, establish novel technology and equipment qualification strategies and lead all aspects of manufacturing process support. The Dir, MSAT must promote a positive work environment for his/her direct reports and support a diverse and inclusive culture across Humacyte.

This position is within Humacyte’s Commercial Manufacturing Operations organization, and reports to the VP of Commercial Manufacturing

Primary Responsibilities:

  • Primary responsibilities include serving as process owner and overseeing the manufacturing process performance, robustness and performing troubleshooting as required. Establish and execute strategic plans to improve process performance.
  • Proactively promote positive Safety Culture and cGMP operating principles.
  • Build and nurture the MSAT team to create a high performing team that embodies action orientation, timely and effective communication, a sense of urgency and where your team is inspired to achieve goals that meet the immediate and longer-term business need.
  • Be an active and visible change agent, promoting a flexible and open mindset that embraces new opportunities, challenges the status quo and drives for excellence.
  • Establishes strategic goals and objectives that drive MSAT responsibilities, organizational performance, and team development.
  • As a commercial manufacturing leadership team member, drives collaboration across the organization, engages in cross-functional planning, and demonstrates critical decision-making. Partners with other leaders and key personnel to establish strategic plans and objectives.
  • Utilize MSAT team's technical skills and process knowledge to participate and/or lead investigations through to root cause determination. Collaborate with impacted groups to develop and execute effective CAPA.
  • Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business).
  • Accountable for overall budget and financial performance of the MSAT organization.
  • Implement, enforce and take ownership of all Humacyte’s Safety, Health & Environmental (SHE) requirements and initiatives within his/her areas of responsibilities. Ensure all employees are competent and provided with the necessary tools and equipment to work safely and without health risks.
  • Provide leadership and direct support on a variety of deliverables including tech transfer, development of engineering protocols, production scale up/scale out opportunities, as well as product and process risk analysis.
  • Own, execute and optimize the MSAT team's deliverables as follows:
    • Work closely with the Process Development (PD) to ensure the design and scale up of processes, instruments & equipment from laboratory, through pilot scale are executable by manufacturing operations when moving into full-scale manufacturing.
    • Partner with Process Development to ensure the successful integration of process knowledge into manufacturing operations, ensuring that technology and process solutions are meaningful, compatible and executed successfully
    • Partner with Manufacturing to ensure that Manufacturing operations are set up for success through the provision of high-quality batch records, robust processes and new technology implementation. Anticipate, respond to and permanently resolve issues that arise during production through use of master data, process & product monitoring etc.
    • Support the Business Development function by providing technical expertise for the development and ongoing refinement of business models.
    • 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.
    • Regularly interacts with Humacyte executives, external collaborators and internal customers. Interactions frequently involve the use of soft skills such as negotiation, influencing, conflict resolution and balancing the interests of the customer with those of Humacyte.
    • Encourage the use of Lean concepts, while fostering and advocating a continuous improvement mindset and culture throughout the organization, by encouraging experimentation and learning.

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:

  • Robust technical expertise in upstream process technologies and their relationship with manufacturing operations and process validation.
  • Detailed understanding of CMC for commercial manufacturing and the related quality systems (change control, deviations investigations etc.).
  • Expert understanding of GMP requirements, particularly as they relate to process operations.
  • Demonstrated robust project management capabilities. Ability to provide leadership for complex projects involving competing priorities.
  • Deep knowledge of process equipment, automation, and validation
  • Possesses outstanding verbal and written communication skills and the ability to influence at all levels.
  • Build a professional network internally and externally. Establish good working relations with manufacturing, quality, engineering, and other support groups to ensure the company goals are met.
  • Able to think strategically and translate strategies into actionable plans. Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
  • Takes responsibility, drives results, and achieves expected outcomes.

QUALIFICATIONS:

  • BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field.
  • MBA a plus
  • 10-15+ years of Biopharmaceutical, Pharmaceutical or Biotechnology industry experience.
  • 5+ years of personnel management
  • Proven experience with innovative and novel biological manufacturing processes
  • Substantial track record of positive interactions with Regulatory Authorities (FDA, EMA, PDMA). PAI experience desired
  • Demonstrated experience in novel bringing biotechnology equipment and processes from design through to clinical and GMP operations.
  • Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing. Familiarity with Pharma 4.0 and Smart Factory concepts strongly desired.

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)
  • 11 Paid Holidays
  • Paid Parental Leave Policies

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