MANUFACTURING LEAD ASSOCIATE

ACS Solutions
Published
January 14, 2022
Location
San Carlos, CA
Category
Job Type

Description

MANUFACTURING LEAD ASSOCIATE

Responsibilities:

  • Foster a positive safety culture.
  • Oversee manufacturing shift activities, leads Manufacturing on-floor production in absence of Supervisor with expectation of 90% on-floor support.
  • Maintain and ensure scheduling of resources and team members.
  • Organize and lead manufacturing associates on a day-to-day basis to ensure daily tasks are accomplished in a safe and compliant manner.
  • Perform daily shift hand-off and end-of-shift communications.
  • Provide clear and timely communication to Supervisor and/or Manager on issues, concerns and metric completion.
  • Mentor and assist in the development and growth of the team. Assist in the training of new employees and existing team members.
  • Creates, reviews, and approves batch records, standard operating procedures, media/buffer tickets, and forms.
  • Utilizes appropriate cGMP principles and policies to solve a variety of problems.
  • Troubleshoot and investigate equipment and process problems, and work with others to implement solutions.
  • Solves problems in complicated situations through application and integration of analytical skills, creativity and judgment aligned with cGMP manufacturing.
  • Leads projects of limited scope; provides training and constructive input to team members.
  • Leads closure of process deviations, investigations and CAPAs.
  • Instrumental in maintaining manufacturing schedule adherence.
  • Impacts business performance and operational efficiency through the delivery of results.
    Qualifications:
  • A minimum of a B.S. Degree in the biological sciences or engineering with three (3) or more years of experience is required and one (1) or more years in a Sr. Manufacturing Associate role in a cGMP environment is recommended.
  • Must be knowledgeable of cGMPs and possess a cGMP, compliance, and technical mindset.
  • Working knowledge of either cell culture upstream operations or downstream operations (chromatography or tangential flow filtration) and buffer/media preparation operations and equipment. Spray dryer experience a plus.
  • Experience in resolving production non-conformances/deviations, implementing corrective and preventative actions, leading improvement projects and initiatives, and validating systems/processes.
  • Possess strong leadership, organizational, and technical skills.
  • Experience with single-use technology a plus.
  • Demonstrates a high level of mechanical and technical aptitude and training.
  • Possess strong verbal and written communication skills.
  • Ability to follow production schedules.
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