Conjugation Leader

Employment Type:Permanent
Job Location:K├Ârnye Hungary
English Description:

 

Main Purpose of the Position

Responsible for supervising the Conjugation manufacturing operation. Main responsibilities include: ensuring adherence to manufacturing schedule, proper operation of all laboratory equipment, availability of supplies and training of staff to meet business objectives, development and revision of Standard Operating Procedures and assuring that processes and products conform to specifications. Provides hands on support and technical expertise to staff.

Primary Responsibilities and Duties

  • Provides supervision to associates including and not limited to: processes, costs, methods, safety, operating plans, and employee results:

Monoclonal and Polyclonal Antibody conjugation manufacturing operation

  • Accountable for ensuring adherence to manufacturing schedule and maintaining detailed production records. Ensures the prioritization of group workload and communication with other departments are done efficiently.   Assures production, quality, and inventory transactions are executed in an accurate and timely manner.

  • Ensures that cleaning, inspection, maintenance, and calibration and proper usage of equipment take place according to schedule.   Maintains related logs and records. Supports equipment troubleshooting activities. Coordinates the purchase of equipment and supplies used in production and in process testing.

  • Ensures adequate resources are provided and are utilized in the most effective manner. Responsible for providing data for the department budget and management of its execution.

  • Develops and revises Standard Operating Procedures and other related documents as needed

  • Carries out Human Resources Management responsibilities including but not limited to:

Executes assigned responsibilities related to hiring, job assignments, terminations, transfers, promotions, employee relations, performance management, salary actions and employee motivation

Exercises responsibility for Employee Training and Development, including train and/or coach associates on technical and nontechnical skills

  • Ensures all EH&S policies, programs and procedures are implemented and followed through education and training.

  • Actively helps establish plant Continuous Improvement program.

  • For Plant Start-up activities the supervisor will support:

Establishment of production laboratory (layout, benches, workflow, equipment purchase and placement, materials and supply management)

Establishment of all production and relevant quality process and procedures

Equipment qualification and process validation

SAP plant start-up activities as assigned.

 

Requirements (Knowledge, Skills, and Abilities)

  • Requires a Bachelor Degree in a related scientific discipline (such as Cell Biology, Chemistry, Biochemistry, Biology, Microbiology or Engineering)

  • Experience in a pharmaceutical/ medical device / biotechnology industry

  • Experience in a supervisory role or equivalent combination of related education and experience

  • Knowledge of ISO requirements highly desirable

  • Effective skills of analytical thinking, problem solving

  • Demonstrated ability to lead, motivate and manage exempt and non-exempt personnel.

  • Fully Bilingual (English and Hungarian).