What are the responsibilities and job description for the Pharmaceutical Development Scientist III position at Bend Bioscience?
At Bend Bioscience, our Core Values Shape Everything We Do:
How You Will Make An Impact
Travel required
- AUTHENTIC – Be vulnerable, build trust
- CURIOUS – Ask questions, be adaptable, speak up
- ACCOUNTABLE – Own it, meet commitments, communicate transparently
- COLLABORATIVE – Engage others, stay open-minded
- FLEXIBLE – Listen actively, be thoughtful, make informed decisions
- CARE – Be passionate, act with integrity
- BLAZE TRAILS – Push boundaries, challenge constraints
- EXCELLENCE – Learn, improve, create value
- FOCUS – Pay attention to details, stay determined, deliver exceptional service
How You Will Make An Impact
- Independently lead development activities for client-based projects, ranging from preclinical to Phase III studies and through registration. This may include creating phase-appropriate strategies for customer-defined product development projects.
- Executing prototype, scale-up and process transfer activities including manufacture, data compilation and evaluation, troubleshooting product/process issues, and perform risk assessment.
- Writing, reviewing, and approving cGMP documentation including batch records, protocols, SOPs, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc.
- Applying QbD principles and use design of experiments and statistical analysis in drug product development as required.
- Maintaining an expert knowledge of equipment, instrumentation, and procedures related to pharmaceutical development.
- Maintaining and expanding knowledge of current and new formulation development technologies and manufacturing processes. Performing literature and patent searches to provide background basis for development plans.
- Attending cGMP training sessions and complying with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
- Working in a GMP environment with a variety of compounds (high potent, DEA controlled substances, etc.).
- Working closely with Analytical Development, Project management, Quality Assurance, and Validations groups.
- Serving as a leader for product development activities with cross-departmental projects teams.M
- Mentoring junior Scientists.
- Leading continuous process improvement initiatives.
- Assisting with scheduling of activities within the group.
- Reliable attendance on a regular full-time basis.
- Exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodying cultural values and aligning daily actions with department and company culture.
- Generally, Eight (8) years of experience in formulation and process development of oral solid dosage forms (tablets, capsules, multi-particulates) with a bachelor’s degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, Pharmacology Or a master’s degree with Six (6) years of relevant experience.
- Hands on work experience in formulation or process development is required, especially with solid oral dosage product types.
- Hands on experience in formulation or process development, specifically with solid oral dosage product types.
- In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry.
- Strong knowledge of common pharmaceutical raw materials, their application, and the principles of formation development.
- Proven experience with statistical design of experiments.
- Strong written and oral communication skills.
- Working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent.
- Ability to prepare presentations, speeches, and articles of publication that conform to prescribed style and format.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
- Working knowledge of regulatory requirements, including FDA (GLP/ cGMP), EMEA, ICH, and regulations in regard to IID, GRAS, residual solvents, bioequivalence studies, etc. for oral formulations.
Travel required
