Pharmaceutical Development Scientist III

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)