Principal Scientist - Process & Formulation

Bora Pharmaceuticals; Maple Grove (MN); Hybrid; USD 142,000 - 185,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

Retirement plan

Paid time off

Professional development opportunities

Wellness programs

Employee assistance program

Job summary

Bora Pharmaceuticals is a premier CDMO providing formulation development, clinical and commercial manufacturing, and packaging across complex dosage forms. This Principal Scientist will lead early-stage formulation and process development, oversee technology transfer, and support on-site client visits, tours, and quotes.

The role emphasizes process understanding, CCPs, and continuous improvement within a cGMP environment, with leadership responsibilities for junior team members and collaboration

Qualifications

• Minimum bachelor's degree in a scientific or technical field with at least 10 years of relevant experience in pharmaceutical product development, manufacturing, and/or process development.
• Master's degree with a minimum of 5 years of the above experience, or PhD with at least 3 years of the above experience.
• Minimum 5 years' experience with oral solid dosage forms including formulation and process development, scale-up, tech transfer, or ongoing commercial support.

Responsibilities

• Lead formulation and process development, scale-up, and technology transfer through commercialization and product lifecycle.
• Directly involved in R&D/DOE, scale-up, and registration batches across development.
• Develop and maintain process understanding by identifying CQAs, CPPs, and process control strategies.

Skills

QbD approach

Process development

Scale-up

Technology transfer

Problem solving

Leadership

Training

Education

Bachelor's degree in pharmaceutical science/chemistry/chemical engineering

Master's degree in the above field

PhD in a related field

Tools

DOE

Pilot-scale equipment

Job description

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

Job Summary

The Principal Scientist - Process and Formulation Development is a significant contributor to CDMO client services from formulation development to process validation and continued product support. This individual will contribute to the quotation process, support on-site visits and tours, and lead teams to complete customer work per the timelines determined. This position will have a strong emphasis on early-stage formulation and process development.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

This position is a hybrid role.

Essential Job Functions

• Understand and lead a QbD approach to early-stage formulation development, including formulation and process evaluation during the early stages of product development.
• Directly involved in successive phases of developmental and technology transfer activities, including production of R&D/DOE, scale-up, and registration batches.
• Develop and maintain process understanding by identifying product CQAs, defining CPPs, and establishing appropriate process control strategies throughout development, scale-up, technology transfer, validation, and commercial support.
• Possess strong technical knowledge of pilot-scale and commercial pharmaceutical manufacturing equipment and unit operations and provide hands‑on support for development equipment and suites as needed.
• Lead formulation and process development, process scale up, and technology transfer through commercialization and throughout the product lifecycle.
• Lead technology transfer gap assessments by comparing processes, equipment, materials, controls, and site capabilities between the current manufacturing site and the receiving site. Identify potential technical risks or process differences and recommend actions to support successful transfer and implementation.
• Support supply and business continuity throughout the product lifecycle by leading continuous process monitoring, troubleshooting production issues and deviations, using problem solving techniques.
• Manage technical changes throughout the product lifecycle, including component, API, and excipient changes; change controls; complaints; and resulting process validation activities in a cGMP environment.
• Responsible for identifying and executing projects to reduce product cost and material usage and improve product quality, yield, productivity, and supply reliability.
• Responsible for process technology training, SOP and batch record writing, technical protocols and reports, including statistical analysis of all study data.
• Provide leadership and work direction to junior level team members.
• Provide training and support to Operations personnel during the development, scale up, registration, and other manufacturing activities on cGMP equipment.
• Support quotations, client site visits, and tours for potential CDMO customers.
• Assist with internal, external, and regulatory inspections including FDA, EMEA, and third-party inspections.
• Support identification of equipment needs based on process and customer program requirements.
• Assist Engineers in capital equipment URS and FSR for critical process equipment.

Minimum Education & Experience Requirements:

This position requires a minimum bachelor's degree in a scientific or technical field (pharmaceutical science, chemistry, chemical engineering, or a related life science), or an equivalent foreign degree, with at least 10 years of relevant

experience in pharmaceutical product development, manufacturing, and/or process development OR a Master's graduate degree in the above field, or an equivalent foreign degree, with a minimum of 5 years of the above referenced experience OR a PhD graduate degree in a related field, with a minimum of 3 years of the above referenced experience.

A minimum of 5 years of experience working with oral solid dosage forms, including experience in formulation and process development, scale-up, technology transfer, and/or ongoing commercial product support. Previous CDMO and leadership experience is preferred.

COMPENSATION RANGE

$142,000 - $185,000

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience.

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.