Bioprocess Associate

WuXi Biologics•Dundalk, MD

4d•Onsite

About The Position

As a Bioprocessing Associate, you will work with the wider Manufacturing teams to support the production of biological products at the Dundalk facility. This role will be responsible for procedures and processes associated with the manufacture of commercial large-scale Drug Substance.

Requirements

Minimum one year experience technical background and working experience from an industrial current Good Manufacturing Practices manufacturing, Contract Development and Manufacturing Organisation, or regulated pharmaceutical facility, with hands-on exposure to: Upstream or Downstream Processing Operations, Biopharmaceutical Engineering or Pharmaceutical Biotechnology, Industrial manufacturing workflows and equipment scale-up.
A minimum of a Certificate, Diploma, or Degree in Science, Engineering Science, or a related field.
Technical knowledge of bioprocessing/biotechnology and Upstream and /or Downstream biologics processes.
Ability to work within and adapt to complex electronic systems such process automation, SAP and Trackwise investigation system.
Must be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, media/buffer systems, and purification systems.
A minimum of one years’ experience in biopharmaceutical or pharmaceutical cGMP manufacturing.
Thorough knowledge of current Good Manufacturing Practices (GMP).
Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs.
Certificate, Diploma, Degree or equivalent in Science, Engineering or related field is essential.
Excellent communication, interpersonal and presentation skills.
Collaborative and inclusive approach to work and your colleagues.
Excellent problem solving and troubleshooting skills.
Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
Engage cross functionally in conjunction with a site-based team.
Autonomous and a self-starter who will use their initiative to drive actions forward.
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.

Nice To Haves

Specific qualifications or specialized programs such as: Pharmaceutical or Biopharmaceutical Degrees, National Institute for Bioprocessing Research and Training Certifications, Pharmaceutical Biotechnology / Biopharmaceutical Engineering, Upstream or Downstream Processing Operations.
Experienced in the Manufacturing function in a ‘greenfield’ context of similar size and scale is an advantage.

Responsibilities

Assist in maintaining a safety-oriented Culture, cGMP compliant work environment at all times.
Where necessary assist in Facility and Equipment start up and Validation activities.
Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products.
Assist as a member of the Production team, towards the delivery of production output targets and quality levels on schedule.
Carry out all production operations in the assigned area as directed by the relevant Standard Operating Procedures and Manufacturing Batch Records.
Perform initial troubleshooting of issues identified during routine operations.
Take part in investigations and optimisations of processes using scientific, engineering and lean principles.
Training and mentoring of colleagues in SOPs, process execution and equipment operation.
Write, review and revision of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instructions.
Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.).
Immediately notify the Shift Lead or Senior Team Member of any deviation from SOPs and/or deviations in the standard production process.
Perform housekeeping duties as assigned to maintain facility at a high standard.
Complete all training in a timely manner.
Maintain assigned training ensuring full compliance at all times.
Adhere fully to all safety policies, procedures and regulations.
Ensure highest Quality & Compliance standards.
Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Shift Lead.
Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.