Lead Manufacturing Associate

Location
Fremont, CA
Posted
Aug 28, 2018
Required Education
Bachelors Degree
Position Type
Full time

Title

Lead Manufacturing Associate

Department 

Manufacturing

Reports to

Senior Director, Manufacturing

Position Description

We are seeking a highly motivated Lead Manufacturing Associate with experience in cGMP manufacturing and cell culture. This position is a lead position within the group and will provide technical expertise to other employees. This individual will perform a variety of procedures in a manufacturing environment in compliance with cGMP regulations to manufacture cell therapy products for use in human clinical trials.

 

Responsibilities

  • Produce cell therapy products using undifferentiated human embryonic stem cells in accordance with the manufacturing procedures, SOPs, and approved protocols in cGMP manufacturing environment
  • Write and/or revise master production records, SOPs, training materials, protocols, reports, and other required documentation
  • Provide support for commissioning and validation activities in addition to other facility start-up activities, as needed
  • Train staff in processing methods, aseptic technique and cGMP clean room operations
  • Organize, coordinate and lead production activities and ensure execution of processes in production while strictly adhering to cGMP regulations, environmental health and safety guidelines, and any other related regulations which could apply
  • Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices are followed
  • Troubleshoot technical process and equipment problems
  • Collaborate with cross-functional teams i.e., Quality, Facilities, Product Development, and Analytical Technologies
  • Perform additional job related duties as required

Requirements

  • BS in Biology/Chemistry/Life Sciences or related field with at least 5-8 years relevant cGMP manufacturing experience in Pharmaceutical/Biotech industry is required
  • Aseptic manufacturing experience is highly desired
  • Mammalian cell culture experience is required
  • Must have proven aseptic technique and be capable of training individuals in aseptic technique
  • Experience writing standard operating procedures and other cGMP documentation
  • Experience writing investigation, deviation and change control documentation
  • Ability to troubleshoot and problem solve in order to initiate, execute, and monitor corrective action
  • Excellent time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities
  • Excellent multi-tasking and problem-solving skills; solution-oriented; self-motivated
  • Must be able to work weekends and holidays when required
  • Excellent oral and written communications skills and a collegial personality
  • Thrives and succeeds in a team-oriented environment
  • Computer literacy including fluency with Microsoft Word, Excel, Outlook
  • Ability to sit or stand for long periods of time, and ability to lift  25-30 lbs
  • Must be able to travel up to 25% as needed

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.