Teva Pharmaceuticals USA, Inc.

Manager Upstream Clinical Manufacturing

Location US-PA-West Chester
Requisition #
18-20700
# Positions
1
Experience (Years)
5
Category
Supply Chain - Global Supply Chain Operations

Overview

The Manager will lead the upstream manufacturing team within the brand new state-of-the art biologics manufacturing facility located in West Chester, PA. This key role supports the development, qualification and overall success of upstream operations of Teva’s proprietary and biosimilar biologics pipeline. We are seeking a seasoned hands-on manufacturing lead to take responsibility for the upstream manufacturing team. The successful candidate will collaborate extensively with the quality assurance, quality control and the automation, equipment and engineering  teams to develop manufacturing policies and procedures, participate in new equipment FAT, commissioning and qualification, develop manufacturing batch record  and work instructions along with production SOP’s, and develop and support environmental monitoring strategies.

The management level position will be responsible for the success of upstream operations. This includes collaboration with internal development teams during technology transfer and supporting quality assurance with batch record review, deviation resolutions and Change Controls to facilitate rapid batch release. The position also requires expertise to identify, trouble shoot and implement improvements within a predominately single-use process train. The individual will write, review and ensure issuance of revised documents as well as review and approve executed required documents including, technology transfer reports, changeover checklists, batch documents, standard operating procedures, deviations and change controls, when necessary.

Responsibilities

JOB RESPONSIBILITIES:

  1. Responsible for upstream manufacturing activities during technology transfer activities and manufacturing readiness activities. This includes responsibilities such as;
  • FAT, SAT /IOQ and PQ activities for process equipment
  • Responsible to write, review and approve documentation such as, master batch records, standard operating procedures and work instructions to meet safety, cGMP and corporate compliance requirements
  • Using root-cause analysis techniques drive closure of deviation investigations
  • Review and approve qualification documentation

 

  1. Responsible for team leadership by setting high standards and work habits to the upstream clinical manufacturing team. Take accountability for the team’s performance by establishing priorities, expectations and best practices. Establish and track manufacturing metrics.

 

  1. Additional responsibilities include:
  • Execute cell culture unit operations from vial thaw through seed expansion, production bioreactor and harvest
  • Train manufacturing operators on operation of manufacturing steps and equipment and maintain a fully qualified upstream manufacturing department
  • Lead trouble-shooting efforts
    • Identify, communicate and remediate faulty process equipment, when needed.
  • Lead deviation investigations, related CAPA’s and complete necessary effectiveness checks as necessary
  • Maintain accurate batch documents according to cGMP requirements and internal procedures and policies
  • Operate manufacturing equipment according to SOPs, batch records and the principles of cGMP, maintain in-process testing equipment, perform in-process testing, perform routine cleaning of equipment
  • Participate execute process development studies, if needed. Manage technical reports and protocol studies as necessary
  • Support production planning by monitoring process inventory and preventative maintenance
  • Lead generation of raw material and consumable specifications. Work with vendors to specify consumable design
  • Analyze and trend in-process data. Represent upstream manufacturing when presenting data in meetings with cross-functional representatives from Process Development, QA, Validation and Management
  • Coach and mentor manufacturing staff as needed
  • Ensure self and upstream staff are compliant with all safety, regulatory, SOPs and corporate training
  • Establish strong partnerships internally to support campaign changeover, scale-up and manufacturing process development
  • Evaluate and implement new manufacturing technologies and systems
  • Provide ownership of qualified process equipment, and manufacturing data
  • Develop manufacturing staff by designing career architecture through goal setting and performance reviews.
  • Other duties as assigned.

Qualifications

REQUIRED QUALIFICATIONS:

 

  • BS in biology, biochemistry or Chemical/Biochemical engineering or in a related life-sciences field
  • 5 years of combined experience in cGMP cell culture manufacturing, manufacturing science and technologies and / or cell culture process development.
  • Hands-on experience with operation, controls and troubleshooting of single-use bioreactor systems,= or feed batch reactors, harvest process equipment (e.g., centrifuges, depth filtration systems etc), in-process testing equipment and strong aseptic technique.
  • Technical knowledge in all aspects of cell culture cGMP manufacturing to include, cell culture, cell banking, and related process equipment.
  • Strong background in aseptic technique and microbial controls.
  • Experience with computerized control systems.
  • Complete understanding of cGMPs as applicable to biologic operations
  • Excellent oral and written communication skills
  • 3 years of manufacturing supervisory experience

PREFERRED QUALIFICATIONS:

 

  • MS in biology, biochemistry or Chemical/Biochemical engineering or in a related life-sciences field
  • 6 or more years of combined cell culture experience within cGMP manufacturing, manufacturing science and technologies and/or process development.
  • Experience with process control SCADA software (e.g., WonderWare )
  • Experience with cell culture process scale-up
  • Experience with automated recipes and control strategies for bioreactor and harvest operations.
  • 4 or more years of leadership experience
  • Green or Black Belt in Operational Excellence, Six Sigma or derivative thereof is desirable
  • Experience with single-use bioreactors and systems

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