Imbrium Therapeutics · 21 hours ago
Sr. Scientist (Formulation) - PAD
Durham, NC
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expImbrium Therapeutics is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new pharmacologic and biologic therapeutics. The Sr. Scientist (Formulation) will provide formulation and process development leadership, manage development activities for various dosage forms, and collaborate with multiple departments to ensure proper product development.
BiotechnologyClinical TrialsMedicalOncologyPharmaceuticalTherapeutics
Responsibilities
Serve as the technical lead for the formulation and process development, clinical supply strategy, manufacturing, product transfers, and scale-up batches of new products and processes, including batch record review, protocol generation/review, supervising batch manufacture, deviation review/approval, generation/review and support of regulatory documents (IND, ANDA, NDA) and deficiency responses with CDMO, etc
Development of potential product/process activities for new products; present proposals to optimize formula and product flow
Provide technical expertise to other departments, as needed, to solve problems; including troubleshooting active products, potential rework procedures for failed batches, or providing general SME expertise as requested
Evaluate new products candidates which may require collaboration with Clinical, Regulatory, R&D, third-party manufacturing sites (CMO/CPO) and Quality to ensure proper development of new products; responsible for coordination of all activities within laboratory area and pilot plant
Evaluation of SOWs for development and tech transfers (as needed)
Coordinate, develop, review and approve protocols for process/product development for internal and external projects
Prepare reports, including data analysis, conclusions and recommendations
Effectively communicate progress, plans and project status, results, and share advice and perspective on future activities; collaborate positively with other lab scientists and influence others through successful negotiation and conflict resolution
Hands-on troubleshooting of product attributes (formula, methods, manufacturing, procedures, etc.) and production equipment involved in the manufacturing process (such as high shear granulators, fluid bed processors, solution prep systems, weighing systems, milling systems, blending systems, tablet compression machines/encapsulators, bead coating, etc.), following all applicable SOP’s, safety standards and procedures
Provide accurate and reliable data; maintain laboratory records and documentation in compliance with Good Laboratory Practices
Exhibit a high degree of independence in managing tasks and activities within area of responsibility. Complete assignments within expected timeframe and with minimum supervision
Follow regulations, policies and guidance pertaining to workplace safety, health, and environmental practices
Assist, mentor, and train other colleagues as requested
Qualification
Required
Bachelor of Science degree required (with 10+ years relevant experience)
Master of Science (with 8+ years relevant experience) or PhD (with 4+ years relevant experience) highly desirable
In depth experience in the fields of Pharmaceutical Product Development and/or Process Development
Detailed knowledge of solid oral dosage forms, formulation development, process development techniques, cGMP regulations, FDA and DEA regulations, and recent trends in FDA approaches
Experience with pharmaceutical manufacturing equipment, and ability to supervise batch manufacture and instruct production operators, if needed
Thorough knowledge of Pharmaceutical unit operations, primarily as it relates to solid dosage forms, liquids, creams, ointments, transdermal delivery systems, and combination products; capable of competent scientific judgments; proficient understanding of the formula/process/system to be studied
Excellent written and verbal communication skills
Ability to respond decisively to changing circumstances without delay during development, DOE, and batch manufacture; demonstrated problem solving skills; ability to be innovative, agile and collaborative
Technical project management skills; above average competencies with Microsoft Office tools
Detail oriented, self-motivated with strong problem-solving and time management skills
In-depth knowledge of industry guidance and awareness of regulatory issues; maintain good laboratory practices in compliance with safety and environmental requirements
Company
Imbrium Therapeutics
Imbrium Therapeutics is a biopharma company that specializes in medical science, pharmacologic medicines, and oncology chemotherapeutics.
11-50 employees
Funding
Current Stage
Early StageRecent News
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