Sr Research Scientist / Sr Data Scientist / Sr Scientist CMC in Vienna, Australia

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Job Description

The Sr Scientist CMC is responsible for driving new, innovative programs to improve the process, and product quality of plasma-derived therapies, optimized for patients. This includes evaluation and process development of new products, alternative fractionation technologies and extraction of new plasma proteins.

In addition this specialist is expected to apply mathematics, problem-solving, and coding skills to manage big data, extracting valuable insights. They design tailor-made solutions from this data, aiding organizations in achieving their unique objectives and goals.

Accountabilities:

• Leading pipeline programs in early-/late-stage process development and providing scientific guidance in CMC clinical development studies and commercialization activities,

• Defining tasks, timelines and budget, interactions with AD, DP, QA, RA, Mfg, MSci etc.

• Acting as an SME and supporting process development, optimization, characterization and tech transfer activities

• Collaborate and review technical documents including protocols and reports, risk assessments and provide input for master batch records, changes, and deviations. Authoring and revision of submission documents.

• Interface between PD team and – other Takeda internal and external partners / companies

• Coaching & mentoring of other Research Scientist to enhance process development capability and statistical capabilities & exchange

• Support statistic, modelling, data science exchange platform within PD team

• Support and advise development of PD software tool set to make process development more efficient

• Ideation on systematic approvement of process development operations to increase efficiency and effectiveness

• Build relationships to external vendors through R&D collaborations including contracting, design of external collaboration, support during execution, data discussion and final closure.

• Collaborate closely with Research Scientists in terms of technical / development activities, study design, data evaluation and modelling applications.

• Develop project resources requirements & schedule and tracks progress of related tasks required for data science activities.

• Work with internal and external partners to develop analytics vision and programs to advance PD activities throughout multiple programs in collaboration with PD sub team leads and PD team members.

• Understand data and sources of data. Strategize with IT development team and develop a process to collect, ingest, and deliver data along with proper data models for analytical needs.

• Interact with business users to define pain points, problem statement, scope, and analytics business case. Develop solutions with recommended data model and business intelligence technologies including data warehouse, modelling, dashboards/reporting, and data queries.

• Collaborate with Enterprise Data and Analytics Team to design data model and visualization solutions that synthesize complex data for data mining and discovery.

• Develop and apply technologies such as machine-learning, deep-learning algorithm to enable advanced analytics product functionality.

• Support technology transfer and scale up activities for processes, as well as providing support to manufacturing as needed.

• Support the enhancement of product and process knowledge and promote application of QbD best practices.

• Identify, evaluate, develop, recommend and/or negotiate novel solutions to meet assigned program needs.

• Demonstrate humility and approachability in encouraging others to challenge ideas and openly raise issues.

• Lead/contribute to enhance individual skills of pharmaceutical product development.

• Lead/contribute to developing the capabilities of the department by identifying opportunities and anticipating changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business and proposing innovative solutions to address them.

• Collaborate with other members in the department to ensures operational standards and practices within the function meet state-of-the-art industry expectations.

Tasks:

• PDT R&D focuses first and foremost on developing therapies that will improve the health care outcomes of patients Takeda aims to serve. Sr Research Scientists within PDT Process Development will be accountable for:

• Explores innovative methods / projects / programs to improve the quality and efficient production of plasma-derived therapies for global and local distribution

• Evaluates new indications, new fractions, new products (including, potentially combinations), and any other process development within plasma to ensure maximal potential of the product to improve health

• Liaises with other R&D functions, GMS/Biolife on joint projects to ensure smooth collaboration experience exchange

• Keeps plasma formulation and related (non-fractionation) techniques at industry state of the art standard, leads projects through PD in alignment and cooperation with CMC lead

• Oversight, design and coordination of project related experimental lab work in internal and external labs (e.g. writing experimental study plans and reports; communication of results within the team and across other functions, hands-on contribution to lab studies)

• Act as PD internal consulter / mentor / coach to support other Research Investigator / Research Scientist colleagues with their projects

Education & Competencies:

• Masters / PhD degree of chemistry, biochemistry, biology, biotechnology, chemical/process engineering or related fields is required

• 5+ years of Pharm Sci pharmaceutical/biotechnology industry experience is required

• Scientific knowledge in process development and about plasma derived therapies fractionation and purification processes

• Good statistical competencies and computer skills

• Good presentation skills

• Good oral and written English and German communication skills required

• Ability to work independent and as part of a collaborative team

• The Sr scientist must be comfortable with working in a fast-paced environment and comfortable with ambiguity

Locations

AUT – Wien – Industriestrasse 72

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time