MSAT Formulation Scientist

Hobson Prior are currently looking for a MSAT Formulation Scientist to join a brilliant biotech establishment on a permanent basis located in London. Our client is focused on manufacturing therapies with the potential to cure serious illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role you will have the responsibility to develop formulations for AAV based gene therapies.
• Conduct stability studies to assess drug product and in-process intermediate stability.
• Develop strategies for improving product stability during the drug substance and drug product manufacturing processes.
• You will be accountable for developing drug product manufacturing processes.
• Appraise drug product container and device compatibility.
• Scale up and tech transfer lab scale unit operations to in-house GMP production facility.
• Construct continuous understanding and knowledge of unit operations, to guarantee process reproducibility and robustness.
• As the MSAT Formulation Scientist, you will support Manufacturing operations with applying new processes and troubleshooting activities.
• Responsible for confirming that any GMP documentation allocated to the candidate such as (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.
• Initiate innovation and challenge conventional assumptions to ensure the company stays on the leading edge of manufacturing science and technology, such as the use of new process technologies, high throughput automated development tools, statistical and mechanistic process modelling and DoE tools.
• Exhaust suitable process analytical tools to generate comprehensive and structured data, improve process comprehension and classify optimisation opportunities.
• You will be responsible for making sure that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Recognising and testing opportunities to simplify our business processes and tools.
• Act as Ambassador for the company at key Cell and Gene Therapy conferences.
• The ideal candidate will draft SOPs and Work instructions for the unit operations that are being developed.
• Accountable for guaranteeing that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.

Key Skills:

• Has established an analytical mindset.
• Great problem-solving capabilities.
• Strong change management skills.
• You are a motivated, innovative individual with high professionalism and great planning and organisational abilities.
• Solid oral and written communication skills.

Requirements:

• Obtained a PhD/EngD/PharmD degree in a pertinent Chemical/Biochemical Engineering or Biochemistry or Pharmaceutical Sciences subject and at least 2 years of biotech industry experience in formulation/downstream process/drug product development.
• You may also apply if you have attained a BSc/BEng or MSc/MEng degree in Chemical/Biochemical Engineering or Biochemistry or Pharmaceutical Sciences or equivalent and at least over 5 years of biotech industry experience in formulation/downstream process/drug product development.
• You can adapt, schedule and write experimental plans according to changes in business priorities.
• Timely completion of experiments according to study protocols.
• Capable of presenting data to key stakeholders in a timely manner to support go/no-go decision points.
• Completion of reports and supporting clinical/commercial filing documentation.
• A strong understanding of the techniques used to characterise the biochemical and biophysical properties of AAV products such as SEC-HPLC, DLS, SLS and AUC.
• Knowledgeable about the mechanisms that cause product instability.
• Solid understanding of the drug substance and drug product manufacturing process used for biopharmaceutical products (e.g. MAbs, Virus, Vaccines).
• Familiarity with the approaches used for developing formulations for different dose forms, e.g., liquid, frozen, lyophilised.
• A good understanding of the design and execution of stability studies.
• Great understanding of drug product development involving the evaluation of drug product vessel/device compatibility is desirable but not essential.
• Robust understanding of GMP and QbD considerations in a large-scale manufacturing setting.
• Comprehension and experience with statistical and modelling software and tools, such as DoE, multivariate analysis, statistical tests (ANOVA, t-test).
• Excellent comprehension of in-process assays such as qPCR, ELISA, HPLC, plate-based spectrometric assays. Understanding of ICH Q2B guidelines desirable.
• A great understanding of molecular modelling and how might be used to investigate product instability and influence formulation development is advantageous but not essential for the role.
• Good knowledge of programming and automated data handling is beneficial but not essential to the role.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.