Job Description

SUMMARY

The Research Fellow, Formulation Development Scientist provides scientific leadership for, and actively contributes to, the early- and late-stage formulation and process development of oral drug products. This position also contributes to drug product development and life cycle management by designing and developing formulations and processes for preclinical & clinical evaluations as well as for commercial technology transfer.

This position works cross-functionally with internal departments and external partners on formulation and process development related activities and issues.

The Research Fellow, Formulation Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

RESPONSIBILITIES

• Independently designs studies and conducts risk assessments as per target product profiles to build in quality-by-design (QbD) during formulation and process development.
• Independently develops robust formulations and manufacturing processes for Phase I-III clinical studies and assists in their transfer to Contract Manufacturing Organizations (CMOs).
• Develops alternate formulations for current commercial products through life cycle management as required.
• Actively and routinely monitors formulation and process development activities at CMOs to meet project timelines.
• Works with Clinical Supplies to plan drug product clinical supply manufacturing campaigns. Leads and supports clinical supply manufacturing activities at CMOs to ensure successful completion.
• Independently conducts process scale up and optimization studies using various QbD tools including design of experiments (DoE) and other modeling and scale-up tools.
• Supports formulation and process technology transfers to commercial manufacturing sites.
• Independently conducts troubleshooting of formulation & processing related challenges and recommends potential solutions.
• Provides formulation and process development support to enable delivery of water insoluble compounds in preclinical and clinical studies by providing viable options of pharmaceutically acceptable formulations.
• Prepares experimental designs, evaluates data and coordinates and executes pre-formulation, formulation, and process development studies on compounds that are nominated for clinical development; identifies pharmaceutical development challenges for such compounds and formulations, conducts risk assessments, and recommends potential solutions.
• Establishes the formulation strategy and development plan for pre-formulation and formulation activities for dosage form development in close collaboration with Clinical Supply, CMC Regulatory, Process Chemistry, Analytical, Project Management and other groups. Leverages knowledge of current drug delivery technologies where applicable.
• Summarizes experimental work in reports, presents the study plans and results to broader teams in a timely manner.
• Authors the drug product sections of regulatory submissions such as Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), or their amendments, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) as necessary.
• Maintains appropriate experimental records in laboratory notebooks.
• Mentors and coaches junior team members.
• Performs other tasks and assignments as needed and specified by management.

QUALIFICATIONS

• PhD degree in a pharmacy or chemistry related discipline and a minimum of 7 years of experience in pre-formulation and formulation development in a pharmaceutical, biotechnology or other related environment OR Master’s degree in a pharmacy, chemical engineering or chemistry related discipline and a minimum of 9 years of experience in pre-formulation and formulation development in a pharmaceutical, biotechnology or other related environment.
• Significant, hands-on experience using formulation and process equipment such as blenders, granulators, roller compactors, tablet presses, coaters, fluid-bed dryers etc.
• Significant, independent, hands-on experience in design and development of oral dosage forms and process scale-up for clinical studies and commercialization.
• Demonstrated knowledge of cGMP and demonstrated, applied understanding of physical pharmacy.
• Demonstrated ability to develop and deliver presentations to senior management on the current status of projects and at internal and external technical meetings on formulation related technologies and trends, as required.
• Working knowledge of different enabling technologies for oral drug delivery of challenging molecules.
• Proven understanding of physical pharmacy & engineering concepts in formulation and process development and related scale-up principles.
• Proficiency with Microsoft Office applications.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Hands-on experience using and troubleshooting analytical instruments (e.g., High Pressure Liquid Chromatography (HPLC), differential scanning calorimetry (DSC), light microscopy, Karl Fisher (KF), X-ray diffractometer), hot stage microscopy, thermogravimetric analyzer (TGA), etc.
• Experience using electronic lab notebook.
• Working knowledge of US and international Chemistry, Manufacturing and Control (CMC) regulations and guidance, including Good Manufacturing Practice (GMP), the US Code of Federal Regulations (21CFR) and International Conference of Harmonization (ICH) guidelines is desired.
• Proven experience working with and overseeing CMOs for formulation development and manufacture for projects is desirable.
• Experience in formulation support work for Drug Discovery.
• Experience managing and developing one or more direct reports.
• Use of Microsoft Project and managing timelines.

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