Bend Bioscience · 1 day ago
Sr Pharmaceutical Development Scientist
Gainesville, GA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expBend Bioscience is a High Science, High Service company committed to advancing human health. In this role, you will support product development strategies on client projects and be responsible for the formulation development and process optimization of challenging pharmaceutical products.
Pharmaceuticals
Responsibilities
Independently leads development activities for client-based projects, ranging from preclinical studies to NDA approval. This will include creating phase appropriate strategies for customer-defined product development projects
Execute prototype, scale-up and process transfer activities including manufacture, data evaluation, troubleshooting product/process issues, and risk assessments
Write, review, and approve cGMP documentation including batch records, protocols, SOPS, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc
Maintain expert knowledge of equipment, instrumentation, and procedures related to product development
Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security
Serve as lead for product development activities within pharmaceutical development group and on cross-departmental project teams, working closely with cross-functional groups to achieve project deliverables
Partners with the Department Director and other research experts to develop new concepts. Assists in developing project plans, business analysis, department budget planning and feasibility assessments
Identify and develop specific training content to support ongoing development efforts. Provide leadership and mentorship to junior team members. Support in developing group priorities, goals and objectives and support staff in achieving objectives. Ensure staff is adequately trained to perform job functions
Qualification
Required
Generally, twelve (12) years of experience in formulation and process development of oral solid dosage forms (tablets, capsules, multiparticulates) with a bachelor's degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, Pharmacology Or a master's degree with eight (8) years of relevant experience
Generally, One (1) year of experience leading and managing teams
In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry
Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development
Proven experience with statistical design of experiments
Strong written and oral communication skills
Proficient in MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent
Ability to prepare presentations, speeches, and articles for publication that conform to prescribed style and format
Ability to present technical presentations to management, research teams and clients/potential clients to ensure understanding and responding to complex questions
Ability to apply logical or scientific thinking principles to a wide range of intellectual and practical problems
Strong working knowledge of regulatory requirements, including FDA, EMEA, ICH, and regulations in regard to IID, GRAS, residual solvents, bioequivalence studies, etc. for oral formulations
Company
Bend Bioscience
Bend Bioscience is a highly experienced contract development and manufacturing organization (CDMO) dedicated to advancing pharmaceutical innovation through cutting-edge scientific expertise and flexible problem-solving.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ajay Damani
Chief Executive Officer
David Vodak
Chief Science Officer
Company data provided by crunchbase