- Education in pharmacology, chemistry, chemical engineering, material sciences or related fields. Must have a BA with 10 years of experience, Masters with 8 years of experience or PHD with 5 years of experiences in R&D, pre-clinical pharmaceutical oral or parenteral formulation design, preparation, and characterization.
- Must have experience in general formulation characterization such as measurement of solubility, pH, viscosity, particle size analysis. Must have experience in using and maintaining lab instruments such as analytical balance, pH meter, centrifuge, mixers, lyophilizer, microscope.
- Experience oral solid and liquid dosage form manufacturing and characterization (granulation, tableting, coating, hardness and friability measurement, dissolution, and disintegration tests) is preferred. Understanding in analytical method and HPLC is preferred.The Associate Director/Group Lead will:
- The group lead will be working with various discovery teams (DMPK, vivarium, chemistry, biology).
- The group lead will oversee the design, draft and execute protocols for formulation experiments. These experiments will include but are not limited to preparation and characterization for peptide or small molecule oral and parenteral dosage forms for preclinical studies.
- Lead a group of 4 scientists and grow the research formulation team as necessary.
- Document experiment processes and results according to GLP standards in lab notebooks.
- Present scientific data to both CMC scientists and multidisciplinary audiences.
- Manage and update preclinical study plans, formulations, and results in shared electronic databases. Maintain formulation calendar.
- General lab responsibilities include preparation for buffers, and vehicles for general lab applications. Manage laboratory excipient inventory and supplies. Engage equipment service and sales representatives for new equipment purchases as well as routine maintenance of laboratory equipment.
- Extra responsibilities may include engaging in developing phase-appropriate formulations for clinical Phase 1 studies, specifically oral formulations. Review preclinical in vivo protocols for formulation composition, storage, stability, and shipping. Coordinate shipment of test articles to external CRO.Compensation:
$190,000 annually
If you are having difficulty in applying or if you have any questions, please contact Alexander Bero at + or
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Associate Director/Group Lead - Newark, United States - Proclinical
Description
Associate Director/Group Lead - Permanent - Onsite
Proclinical Staffing is seeking an Associate Director/Group Lead to join a cutting-edge biotech company. This is a permanent role located in San Francisco Bay Area.
Primary Responsibilities
The role of group lead within the formulation group is to support preclinical studies for discovery projects as well as formulation development for clinical phases as needed.
Skills & Requirements: