ASSOCIATE PRINCIPAL SCIENTIST SKILLS, EXPERIENCE, AND JOB REQUIREMENTS
Updated: Aug 6, 2024 - The Associate Principal Scientist possesses extensive expertise in Good Documentation Practices and current Good Manufacturing Practices for sterile dosage forms, alongside knowledge of current ICH Quality norms in Manufacturing Science and Technology. This role involves applying Quality by Design principles to process development and life cycle management, conducting the Design of Experiments, and performing robust statistical data analysis. Additionally, responsibilities include authoring and reviewing CMC regulatory documentation, managing projects with sophisticated tracking tools, and optimizing processes for the manufacture and scale-up of sterile drug products.
Summary of Associate Principal Scientist Knowledge and Qualifications on Resume
1. BS in Biology with 5 years of Experience
- Developing statistical and computational methods to analyse HTS data sets to identify and extract the information to identify compounds of interest.
- Expected to champion the use of computational methods internally as well as represent HTS and AZ externally.
- Supporting scientific development of the department across all areas.
- Significant experience in the pharmaceutical industry and drug discovery process
- Well-developed understanding of molecular and cellular biology
- A proven track record in the application of computational and/or statistical methods to large biological data sets ideally in a drug discovery setting.
- Ability to drive the practical application of computational and/or statistical approaches to drug discovery.
- A history of scientific publication/presentation.
- An advanced degree in a related field and/ or professional certification
- Ability to code in R, ability to code in a language such as Python
2. BS in Biochemistry with 7 years of Experience
- Familiarity with methods and instruments used for protein characterization such as LC-MS (peptide mapping, intact mass analysis and oligosaccharide profiling), icIEF, CE-SDS, HPLC (SEC, RP, HIC, IEX, HILIC) and SEC-MALS
- Expert appreciation of running Mass Specs and how to use the data
- Experience of Complex proteins – Complex antibodies – Complex Molecules
- Understanding of protein structure, post-translational modifications, and degradation pathways for recombinant proteins
- Understanding of phase appropriate regulatory and quality expectations for clinical phase analytical characterization and comparability studies
- Understanding of analytical control strategies applied to biopharmaceutical products
- Putting together Packages of Work and Designing of Experiments
- Ability to query databases using SQL
- Excellent communication skills to facilitate knowledge transfer to HTS scientists
- Understanding of the analysis and interpretation of screening data
3. BS in Biotechnology with 6 years of Experience
- Knowledge in Good Documentation Practices (GDPs).
- Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
- Experience with utilization of QbD principles to process development and life cycle management.
- Experience in Design of Experiments (DoE) and statistical data analysis.
- Experience in authoring and reviewing CMC regulatory documentation.
- Analytical problem-solving skills.
- Project management and activities management skills (dashboards, activity trackers).
- Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
- Experience in process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
- Competency in technical writing.
4. BS in Environmental Science with 4 years of Experience
- BSc in a relevant scientific discipline or relevant previous experience
- Working knowledge of protein structure, post-translational modifications, degradation pathways and
- Experience in Critical quality attributes relevant to biopharmaceutical products
- Hands-on experience in developing analytical methods for use on novel biopharmaceutical products
- Experience in solving technical problems observed during method development and routine method operation
- Experience in the use of statistical tools such as DoE to support method optimization
- Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
- Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing).
- Must be able to travel for this position.
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