Scientist I – Purification Sciences

Bora Pharmaceuticals; Rockville, Northern (MD, KY); Hybrid; USD 75,000 - 104,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

401(k) with matching

Paid time off

Professional development

Wellness programs

Employee assistance program

Job summary

Bora Biologics, a Bora Pharmaceuticals company, seeks a Process Characterization and Validation Scientist to design, execute, and report studies for late-stage programs, ensuring rigorous documentation and traceability.

Collaborate with Development, Manufacturing, Validation, and Regulatory Affairs to transition products from development to commercialization, emphasizing compliant records and clear communication.

Qualifications

• BS/MS/PhD in the biological sciences or related field.
• Design process characterization and process validation studies and author protocols.
• Execute characterization studies to establish process understanding and define critical process parameters.
• Support process validation activities by executing studies and interpreting results.
• Maintain accurate laboratory records and ensure compliance with quality and safety requirements.
• Generate and communicate experimental results through reports and summaries for internal teams and clients.

Responsibilities

• Design, execute, and report characterization and validation studies for late-stage programs.
• Collaborate with Development, Manufacturing, Validation, and Regulatory Affairs to transition products to commercialization.
• Maintain accurate records and ensure activities comply with quality and safety requirements.

Skills

Process characterization

Process validation

DoE

Technical writing

Cross-functional collaboration

Education

BS/MS/PhD in biological sciences

Tools

ÄKTA purification system

HPLC

Capillary electrophoresis

ELISA

Job description

About Bora:

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from First‑in‑Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose‑built for commercialization. Our inspection‑proven, bi‑coastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job Summary:

This position is responsible for the design, execution, and reporting of process characterization and process validation studies for programs entering late-stage development. The successful candidate will have a good understanding of the role of characterization and validation studies in process development, with excellent attention to detail and record keeping, and strong communication skills. The individual may also contribute to the development of novel processes or optimization of existing processes for programs in an earlier stage of development. The position necessitates a collaborative approach with other Development functional groups, Manufacturing, Validation, and Regulatory Affairs, towards the goal of transitioning products from development to commercialization.

Essential Functions:

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Education & Credentials

• BS, MS, or PhD in the biological sciences or related field

Preferred Qualifications

• Salary Range: $75,000-$104,000
• Design process characterization and process validation studies and author protocols.
• Execute process characterization studies to establish process understanding and define critical process parameters.
• Support process validation activities by executing studies and interpreting results.
• Maintain accurate laboratory records and ensure activities are conducted in compliance with applicable quality and safety requirements.
• Generate, interpret, and communicate experimental results through technical reports, presentations, and development summaries for both internal teams and clients.
• Collaborate with analytical, upstream, formulation, and manufacturing teams to support integrated process development activities.
• Other duties as required
• BS with a minimum of 4 years of experience, MS with a minimum of 2 years of experience or PhD with no previous experience
• Minimum of 4 years of biotech industry experience
• Possess in-depth understanding of downstream unit operations
• Understanding of downstream process development and process transfer to manufacturing
• Experience operating purification equipment such as ÄKTA or equivalent
• Familiarity with small-scale model studies using Design of Experiments (DoE) approach
• Familiarity with process validation at both small and large-scale
• Excellent technical writing skills and oral communication skills
• High energy results-driven individual
• Willingness to be hands on
• Experience performing biologics analytical techniques (HPLC, Capillary Electrophoresis, ELISA)

Compensation and Benefits

• 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.

Equal Employment Opportunity Statement

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. Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories.