Pharmaceutical Development Scientist II

At Bend Bioscience, our Core Values Shape Everything We Do:

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

Join Bend Bioscience and be part of a dynamic team that makes a real difference.

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.

What You Will Bring to the Role:

• 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.

Special Working Conditions:

Travel required