Operations Leader

Posted 4 Days Ago
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Roswell, GA
Mid level
Biotech
The Role
The Operations Leader supervises Processing Technicians in the manufacture of transplantable products. Responsibilities include ensuring safety and quality in processing, training staff, managing daily activities, adhering to safety procedures, and leading team projects. This role includes employee performance monitoring, coaching, and participation in hiring processes, among other duties.
Summary Generated by Built In

Reporting to the Associate Director of Operations, leads and supports a staff of Processing Technicians in the manufacture of transplantable products derived from human cells or tissues. These products are derived from donated human tissue and are processed with the utmost attention to the safety of the processing staff and quality of the final product. Supervisors are responsible for providing appropriate training and monitoring of their direct reports to ensure the safety of all employees and the production of high-quality products. Operations Supervisors are expected to plan, lead, and actively participate in daily processing activities. Supervisors will work with their Director towards achieving the overall strategic plans for the department. This role is an on-site role working Wednesday through Sunday 7am-4pm. 

KEY DUTIES AND RESPONSIBILITIES

  • Provide necessary instruction and motivation daily to achieve tactical objectives related to safety, quality, delivery, cost, and people.
  • Develop and coach employees ensuring support and guidance for all operations related procedures, work instructions, and forms.
  • Ensure adherence of staff to all safety procedures and monitor and report potential safety issues to Director and Safety Director.
  • Ensure observance to dissect, inspect, and package human cells, tissues and cellular and tissue-based products in accordance with all Standard Operating Procedures and Work Instructions.
  • Create and revise procedures as required with minimal guidance; update processes, as needed, for compliance.
  • Understand and apply current Good Documentation Practices (cGDP) while ensuring accountability for team adherence to cGDP.
  • Oversee employee training to ensure timely completion.
  • Lead short-term and ongoing projects in support of the company and with oversight of management.
  • Perform investigations to root cause for non-conformances ensuring gaps are closed to avoid recurrence.
  • Participate in forming and executing production plans to deliver to organization growth and performance.
  • Make corrections on behalf of absent or unavailable employees as a Management representative.
  • Team Leadership and Management of Maintenance and accuracy of training records; Employee timekeeping and scheduling; Regular 1x1 meetings and performance feedback; Employee coaching and development
  • Participate in the hiring process for new staff members.
  • Perform other duties as assigned by StimLabs management.

EDUCATION/CERTIFICATION

  • Bachelor’s degree or related experience in a technical field, or an appropriate combination of education and work experience.
  • At least 2-3 years of experience in Tissue Processing or Aseptic Processing environment preferred. 

REQUIRED KNOWLEDGE

  • Proven success as a coach, helping teammates achieve their personal goals and motivating the entire team to work as a cohesive unit focused on meeting the needs of our patients.
  • Knowledge and experience working within a regulated industry and/or under cGDP/cGTP/cGMP standards required.
  • Experience working in an AATB regulated facility preferred.
  • Proven ability to.direct and take responsibility for the work of others.
  • Knowledge of and ability to apply root cause analysis.
  • Able to lift and carry up to 25 lbs., stand or sit for up to 4 consecutive hours.
  • Basic computer skills including MS Office, required.
The Company
HQ: Roswell, GA
214 Employees
On-site Workplace
Year Founded: 2015

What We Do

StimLabs was founded in 2015 with a desire to advance the state of regenerative medicine. In pursuit of this goal, StimLabs has gathered exceptional scientific and clinical minds to develop and commercialize new bioactive technologies. Within a year of its inception, StimLabs conceptualized and launched a suite of amniotic-derived products, developed an extensive product pipeline across a range of clinical applications, and established a portfolio of intellectual property.

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