Senior Scientist, Biologics Formulation
- Employer
- JOINN Biologics
- Location
- Richmond, CA, United States
- Start date
- Sep 30, 2020
View more
- Discipline
- Clinical, Manufacturing & Production, Materials/Inventory Control
- Required Education
- High School or equivalent
- Position Type
- Full time
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The Formulation Senior Scientist will provide technical leadership for the development of pre-clinical and early clinical stage candidates forms following quality by design (QbD) principles for the delivery protein-based therapeutic agents. The successful candidate will be expected to drive programs from inception through pre-clinical manufacture/screening, technology transfer, early cGMP manufacture, working closely with Quality and CMC counterparts as well as any necessary analytical method development, specification development, and assessment of stability data/programs.
Essential Duties and Responsbilities:
Required Experience / Skills
Location: Richmond, CA 94806
Work authorization: United States (Required)
Essential Duties and Responsbilities:
- Independently performs and implements formulation strategies
- Development of inject-able biologics dosage forms following quality by design (QbD) principles.
- Identifies drug product critical quality attributes impacting safety, efficacy, and manufacturing robustness. Provides input to define phase appropriate regulatory specifications.
- Performs screening of buffers, excipients, solubilizers, etc
- Pre-formulation characterization of preclinical and clinical compounds.
- Authoring and review of written documents including development reports, technical memos, etc.
- Serves as formulation lead in multidisciplinary project teams and/or sub-teams.
- Responsibilities for equipment maintenance and calibration, housekeeping, and other support functions (e.g., inventory of consumables and reagents).
- Work effectively in a cross-functional matrix environment, with internal and external customers and proactively communicate with internal and external stakeholders.
Required Experience / Skills
- 3-5 years' industry experience with MS or PhD degree in related scientific discipline, or 6+ years' industry experience with BS degree in related scientific discipline.
- Will have expert understanding of pre-formulation and formulation area and uses published literature to extend understanding as well as consulting internal and external experts as needed.
- Highly independent and self-motivated and integrates well within a team.
- Ability to establish and maintain effective working relationships.
- Strong ability to trouble-shoot technical problems.
- Detail oriented, with good organizational skills and project management skills.
- Able to work in a high paced team environment meet deadlines and prioritize work on multiple projects.
- Excellent oral and written communication skills.
Location: Richmond, CA 94806
Work authorization: United States (Required)
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