MANUFACTURING LEAD ASSOCIATE
- 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.
- 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.