Sr. Scientist, Formulation Development

About the role

We are seeking a talented and motivated Sr. Scientist, Formulation - Injectables to join our team. In this role, you will be responsible for the formulation and process development activities associated with drug product development projects following Quality by Design (QbD).

Responsibilities

• Development and execution of product development strategies that are aligned to relevant regulatory processes, QbD/QbR requirements and guidelines.
• Formulation design and development, as well as associated technical decision making.
• Develops and executes robust experimental designs (e.g. using factorial design DoEs) studies to the highest scientific standards to achieve the center’s goals. Including working knowledge of statistical data interpretation tools.
• Seeking and incorporating feedback/requirements from the Technical Services teams with Operations into formulation development.
• Collaboratively working with R&D colleagues, Technical Services, Regulatory Affairs to ensure all submission documents are prepared to the highest quality and to pre-determined timelines.
• Keeps abreast of relevant literature and developing visibility outside of functional area. Continues to improve the center’s technical knowledge and product development processes.
• Responsible, in collaboration with management, to develop and track project timelines and assumes departmental responsibility for projects when necessary. May deliver updates to senior level management in context of overall project goals.
• Assumes additional responsibility for departmental staff as needed including recruiting, managing, and developing scientific staff.
• Contributes to departmental administration. Demonstrates fiscal responsibility with respect to lab equipment need and capital cost projections, cost of experiments, technology, external collaborations, and travel.
• Responsible for technical reporting and quality in a timely manner where thoroughness and correctness are critical to successful transfer of products to operations sites.
• Maintain publication/presentation/patent record as appropriate for discipline.
• Has ability to participate as representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals.
• Acts as the department representative and communicates the line recommendations to the project team and reports back the project team decisions to the line management.
• Develops broad knowledge in field of expertise, including the ability to interpret current literature relevant to R&D projects, and visibility outside of functional area. Provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects.
• May be involved in or may lead in product lifecycle activities including analytical and process optimization, actions associated with product monograph updates, actions associated with regulatory guidance updates and actions associated with corporate site renovation, new construction or acquisitions.

Requirements

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline, with at least 10 years of experience developing pharmaceutical formulations from development through commercialization.
• Extensive knowledge of parenteral formulation platforms, materials characterization, process development, and scale-up of sterile injectable products.
• Expertise in manufacturing process development and scale-up, including filter validation.
• Strong understanding of analytical techniques used in pharmaceutical development, including HPLC, GC, LC/MS, and spectroscopic methods.
• Thorough knowledge of FDA regulations, ICH guidelines, and ANDA submission requirements.
• Advanced technical training and demonstrated expertise in pharmaceutical formulation and product development.
• Proficient in Microsoft Office applications (Word, Excel, Outlook), project planning tools, and general computer systems.
• Strong problem-solving and troubleshooting skills with a systematic, data-driven approach.
• Effective verbal and written communication skills with the ability to collaborate across multidisciplinary teams and lead productive meetings and teleconferences.
• Demonstrated leadership, influence, and stakeholder management skills.
• Self-motivated with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline, with at least 10 years of experience developing pharmaceutical formulations from development through commercialization.
• Ph.D. in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline, with a minimum of 8 years of experience developing pharmaceutical formulations from development through commercialization.
• Extensive knowledge of parenteral formulation platforms, materials characterization, process development, and scale-up of sterile injectable products.
• Experience developing controlled-release parenteral formulations.
• Strong understanding of analytical techniques used in pharmaceutical development, including HPLC, GC, LC/MS, and spectroscopic methods.

Skills

• Statistical data interpretation tools.
• Microsoft Office applications (Word, Excel, Outlook).
• Project planning tools.
• General computer systems.
• Problem-solving and troubleshooting skills.
• Verbal and written communication skills.
• Leadership, influence, and stakeholder management skills.
• Self-motivation.

Benefits

N/A

Pay

Base Salary: $66,600.00 to $133,750.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors.

Schedule

N/A