What are the responsibilities and job description for the Downstream Manufacturing Associate position at Pharma Universe?
The role will involve performing downstream manufacturing to assure that the process is robust, scalable, and able to be performed in the manufacturing facility - as well as the accompanying documentation. The successful candidate will be familiar with cGMP regulations and technology transfer tasks and work out of the brand-new state-of-the-art facility in New Jersey, USA.
This position requires great attention to detail, ability to work in a team environment and a keen interest in optimisation of processes. Scientists will be responsible for adhering to all Quality Management System procedures, safety policies, and relevant parts of cGMP.
Responsibilities:
This position requires great attention to detail, ability to work in a team environment and a keen interest in optimisation of processes. Scientists will be responsible for adhering to all Quality Management System procedures, safety policies, and relevant parts of cGMP.
Responsibilities:
- Perform as a key member of the Downstream Manufacturing team, liaising with Process development and QA teams
- Design and optimize downstream processing steps, including DNA purification techniques such chromatography, tangential flow filtration and formulation
- Wide experience using AKTA systems, TFF system and deep understanding of DSP processes from a technical point of view
- Stay up to date with current technologies and literature as well as evaluating these new technologies/processes for implementation
- Provide hands-on supporting during manufacturing campaigns, including troubleshooting and resolving production issues
- Assist with tech transfer activities from the Process development department to the cGMP manufacturing facility
- Generate documentation, such as reports/experimental write-ups, that support the validation of processes and during the production's campaigns
- Execute and deliver projects to a high standard and in accordance with project validation plans
- Analyse data from experiments, interpret results and implement processes
- Record experimental methods and results to a high standard and in-line with company guidelines, maintaining QMS documentation as necessary
- Attend and participate in relevant meetings, training, and development sessions
- Use, maintain and respect company equipment in accordance with the company's SOPs and health & safety guidelines
- Train and mentor junior staff in downstream processing techniques and GMP practices
- Undertake any other appropriate roles and responsibilities that reasonably fall within the role holder's skills and experience as requested
- MSc in Biochemical engineering (or similar) or BSc in biological sciences, or a related discipline with relevant industry experience (2 Years)
- Experience of working in downstream processing in controlled environments employing quality standards (e.g., ISO, cGMP, cGLP, cGCP)
- Experience with Chromatographic process development using AKTA systems
- Experience with scale up and/or tech transfer of chromatographic processes would be desirable
- Experience with TFF systems
- Experience of experimental planning, experimental validation and report writing
- Experience in analysis of chromatographic data and understanding the implications of certain product impurities
- Familiarity with regulatory requirements for biopharmaceutical manufacturing
- DoE experience using software packages such as JMP would be desirable but not essential
- A creative and open mindset to tackle novel challenges
- Excellent team working and communication skills
- Excellent record keeping skills
