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  • Job reference: RMS0169442

Lead Production Technologist

  • Sector: Engineering
  • Location: Billingham
  • Job type: Permanent
  • Date posted: 07/07/2016
  • Time left:
    d h m s
This vacancy has now expired.
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The Company:
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .

The Role:
To lead Technology Transfer into and manufacturing operations within the MCC GMP production facility whilst exemplifying the core values of the Biomanufacturing Excellence Mission Statement (Reliable, dependable, high quality and flexible).

Key Techniques:
• Line Management of manufacturing team members
• Technology Transfer
• Customer interaction
• Root-Cause Analysis
• Office skills: Word, Excel, Powerpoint, Trackwise

1. Demonstrate ownership and leadership within the manufacturing environment by ensuring relevant EHS and GMP standards are continually maintained. The job holder will lead by example and demonstrate the ability to challenge and change unacceptable practices to continually improve ways of working in manufacturing.

2. Has extensive knowledge of the manufacturing process and operation of associated production equipment, acts as the primary manufacturing contact throughout the lifecycle of Technology Transfer and process execution (GMP preparation, manufacture and batch disposition).

3. Collaborates within programme teams to create all documentation required to execute a manufacturing process, ensures processes transferred to the manufacturing facility are designed to operate safely and compliantly.

4. Creates, monitors, executes, adjusts, and communicates manufacturing plans and co-ordinates associated production team resource to achieve manufacturing schedule targets.

5. Provides appropriate decision making and assessment of impact on product quality through a thorough understanding of the theoretical concepts and principles relating to cGMP manufacture.

6. Leads process related investigations in collaboration with development and engineering teams to establish the root cause of failures.

7. Interacts with customers and regulatory agency personnel during visits, audits and manufacturing status communications.

8. Any other duties commensurate with grade.

Personnel working in the manufacturing facilities must be highly skilled to ensure successful process transfer and execution and flexible to the needs of the manufacturing schedule.

Essential Skills / Qualifications:
Degree qualified
MCC experience preferred
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