Manufacturing Team Lead - Support Services

La Jolla, CA

Job Req code: 740

Category: Manufacturing Operations

Directs, assists with, instructs and reviews the daily work in the Support Services group. This includes all activities associated with the support functions in the manufacturing facility.  Responsible for ensuring the approved procedures are being followed per SOP.  Reviewing and retaining accurate daily logs and records as well as instructing subordinates with training needs. 

Will be responsible for troubleshooting manufacturing production challenges as they pertain to the Support Services department including; coordination of special requests for the assembly and sterilization of sub-assemblies, material management and process kitting, ensuring the quality system is being adhered to, coordinating variances in run rates, and giving direction on the floor in the absence of the direct supervisor.  Follows established company rules, regulations and safety precautions, and maintains quality standards.

Perform various responsibilities that are required to support the manufacture of a living tissue.  Some of these duties include: proper set up and use of many custom built pieces of equipment, preparation and sterilization of sub-assemblies, material management which consists of timely transfer and replenishment of materials and/or supplies to point-of-use locations, inventory accuracy and process kitting.  Schedule and distribute work to fellow employees, with minimal direction from supervisor, to ensure the uninterrupted process of product in and out of the area. This includes making decisions related to daily activities, break schedules, prioritizing of work, etc.  Utilize resources efficiently to make sure that all manufacturing schedules are met.

Assists the Supervisor in ensuring responsibilities and functions are performed in a safe and compliant manner.  Review in-process and completed documents for accuracy and to make sure batch records are turned in within specified days of completion.  Perform real time MRP transactions to support materials and supply chain management.  Regularly instructs and trains departmental employees in job procedures, equipment operation, safety and other phases of their job, as necessary. Assist in providing positive and constructive individual feedback and building teamwork.  Ensures that high standards of quality and teamwork are adhered to, (sets example for other employees).  Promote continuous process improvement methodologies.  Schedule and coordinate with multiple departments including Cell Expansion, DG Growth, Solutions Prep, Packaging, and Research groups for daily needs and special requests.  Lead daily Support Services group task meeting to align all personnel for execution of each days scheduled expectations. 

Perform basic preventive observation maintenance for all mechanical, computer, and process related equipment and submit necessary work requests to maintain operations at peak efficiency.  Assist Supervisor with additional duties as necessary—Quality Even Notification (QEN), Change Order (CO) and any other quality issues that are applicable.  Assist in providing feedback and input into mid-year and annual reviews of employees, if requested by Area Supervisor.  Assist with the interviewing process of new manufacturing candidates.

Requirements

Education and Experience Requirements:

A minimum of 5 years prior working experience in a regulated manufacturing environment (Biotech/Pharmaceutical Industry) is desired.

An Associate’s degree in life science, or 2 years equivalent relative experience required.  The lead operator must have extensive working knowledge of a cleanroom environment and current Good Manufacturing Practices (cGMP’s).  They must have experience in an assembly type of environment and be able to adapt to changes while prioritizing quality system requirements.

The ideal candidate must have experience in material management and inventory cycle count.  Able to train others on support processes and cGMP related procedures.  Must be extremely detail-oriented, organized, and have a strong ability to ensure the quality system is maintained on the production floor.  Excellent verbal and written communication skills and the ability to interact effectively with supporting teams are highly desired.

 

Key Skills, Abilities, and Competencies:

Ability to multi-task, to generate process related data, and communicate daily tasks to Production, Quality, and other operations teams.  The ability to think abstractly and sequentially with regards to process impact is paramount.   Strong ability to write reports, business correspondence, Standard Operating Procedures (SOPs), and Quality/Compliance related documents.  The lead operator must have the ability to effectively communicate with groups of managers, clients, and customers, both internal and external. They must have a strong ability to ensure daily planning and procedures are carried out in the absence of area supervisor.

 

Complexity and Problem Solving:

Ability to problem-solve/troubleshoot, to be multi-faceted to ensure optimal decisions are made while collaborating with external groups. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

 

Internal and External Contacts:

Collaborate with sub-teams within Technical Operations and across departments.

 

Other Job Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Working with extreme cold temperatures is required.  Must clothe in necessary room gowns, and wear proper PPE’s to perform duties.  Must be able to push 150+ lbs (on wheels), and lift 50lbs and work with various chemicals.  Strong communication and listening skills are required.  Due to the nature of production work, overtime and weekend work is a requirement of employment and is variable based on company needs.