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Scientist Senior Associate
Job Description
This role in Pivotal Drug Product Technologies will be to provide support of drug product formulation and process development of biologics. The candidate will work closely with a team of engineers and scientists responsible for the technical aspects of the client's drug product commercialization and lifecycle management.
Responsibilities:
Responsibilities:
- Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics.
- Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
- Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization, particle quantitation/characterization, physical properties, etc.
- Data analysis and documentation/review in electronic notebooks.
- Author, review, and data verify technical documents such as protocols, reports, regulatory documents, etc.
- Clearly and consistently communicate data in progress reports and presentations.
- Participate in cross-functional teams in a fast-paced environment to progress product development.
- Adhere to all training, compliance, and safety guidance.
- Support lab operations and inspections as required of all lab-based staff.
- Work primarily onsite with remote work as appropriate to role and tasks.
- Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
- Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization, particle quantitation/characterization, physical properties, etc.
- Data analysis and documentation/review in electronic notebooks.
- Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience
- Bachelor’s Degree in Engineering, Chemistry, Biochemistry, Pharmaceutics, Materials Science, or related discipline with at least 2+ years of relevant laboratory work experience. Or Masters degree without any experience.
- Understanding of physical/chemical stability of proteins.
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with procedures and policies.
- Proficient computer skills, including Microsoft Office, PowerPoint, Word, and Excel.
- Self-motivation, adaptability and a positive attitude.
- Critical thinking, problem solving, and independent research skills.
- Good organizational skills with strong attention to detail.
- Excellent oral and written communication skills.
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