Senior Specialist - Engineering

Role Functions

(Functions include, but are not limited to, the following)

THE ROLE

Reporting through the site manufacturing and technology head the Senior Specialist, Process Engineering responsibilities include, but are not limited to the following:

· Support the design, construction and qualification of upstream & downstream equipment through to technology transfer and commercialisation.

· Support establishment of the commercial process and routine manufacturing by:

o Supporting experimental design, execution, data analysis and interpretation.

o Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.

o Supporting deviation management.

o Supporting change control prioritisation and implementation.

o Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.

o Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.

o Applying LeanSixSigma tools by:

§ Securing continuity of an appropriate LSS level of knowledge.

§ Facilitating problem solving & risk assessment (FMEA) projects/meetings.

§ Making problems visible and strive for continuous improvement.

o Serving as a key member during internal audits and external inspections/audits

· Lead and support various manufacturing science and technology organisational initiatives as needed (examples include safety, financial forecasting, work standardisation, etc).

· Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

This role may require shift work support after the facility startup phase is complete.

Experience, Knowledge & Skills

THE CANDIDATE

This role requires an experienced individual with a minimum of 5 years' (for MSc) or 7 years' (for BSc) directly related experience in academia, pharmaceutical or biotechnology company - along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.

A self-starter and results-focused, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.

S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.

With a Bachelor's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience), the successful candidate will also ideally have a proven track record in delivering excellence.

Preferred Experience and Skills:

• Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
• Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
• Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
• Working knowledge of statistical process control (SPC), multivariate analysis (MVDA

Qualifications & Education

· Bachelor's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience),