Job Description

Current Opportunity

BTG Specialty Pharmaceuticals provides rescue medicines typically used in emergency rooms and intensive care units to treat patients for whom there are limited treatment options. We are dedicated to the development, manufacture, and commercialization of quality medicines that make a real difference to patients and their families. Our current portfolio of antidotes counteract certain snake venoms and the toxicity associated with some heart and cancer medications. To learn more, visit: btgsp.com.

Broad Function

To perform routine test procedures and supporting tasks within QC to ensure the timely generation of valid test results for the purpose of controlled product manufacture. Train staff as required for the smooth operation of the production process.

Principle Responsibilities

Support the production of low bio-burden serum from the blood harvested in the Sheep Production Facilities by:

• Analysing serum samples according to written, validated procedures
• Primary assays include but are not limited to Bioburden, Endotoxin, Biacore assays and Polarisation Fluroimmunoassay.
• Involvement in Environment Monitoring Program for the manufacturing areas within the serum production facility at Turretfield.
• Ensure samples tested by external contract facilities are appropriately labelled, packaged and are dispatched in a timely manner.
• Collate and review all results in a timely manner for serum release.
• Monitor antibody production in sheep using appropriate assays
• Participate in development of new methods required for the purposes of routine testing of low bioburden ovine serum, antibody and health monitoring of production flocks and qualification of new sheep for production status
• Assist in the transfer of any new assays from external sources or from the BTG UK site
• Ensure all quarantined incoming goods are assessed for release against a written specification.
• Write and review SOPs, Work Instructions, Laboratory Methods, Specifications and AQR’s as required to ensure procedures are documented and all documents are accurate and complete.
• Ensure all equipment is calibrated and maintained in accordance with written procedures
• Draft calibration documents for new equipment as required
• Participate in Internal and External Audits as required and complete all associated actions in a timely manner

Education and Experience

• An educational background in Biological / Analytical Science is required (i.e. Microbiology, Biotechnology, Chemistry, Biochemistry, and Immunology).
• Previous experience in a Quality Control laboratory is preferred but not essential
• Ability to prioritise workload to meet deadlines within tight timeframes with minimal supervision;

Skills and Attributes

• Confident with the ability to work with employees at all levels of seniority utilising excellent communication skills, both on an internal and external basis.
• Competent, methodical, highly organised individual who pays strict attention to detail and has the ability to effectively prioritise and execute tasks accurately within a high-pressure environment. Organisational skills should be strong with an ability to plan ahead.
• Creative thinker able to solve problems, question the status quo and consider innovative solutions to complex issues.
• Must be able to work as part of a team and demonstrate initiative when required with a flexible and willing attitude at all times.
• Strong written and oral communication skills.
• Highly self-motivated and directed.

BTG Specialty Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.