Associate Scientist I - Technical Services

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

Completes projects that provide general technical support for production operations and validation testing of production quality systems.

This role requires to be onsite.

Essential Functions

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

• Support the development and execution of process validation (PPQ) protocols and technical reports for commercial manufacturing and product transfers within a CDMO environment.
• Assist in technology transfer activities, including risk assessments, development, scale-up, and validation of client processes at the manufacturing site.
• Coordinate and execute validation and tech transfer activities with cross-functional groups, ensuring adherence to project timelines and cGMP requirements.
• Conduct process development, engineering, and optimization studies to support successful scale-up and technology transfer.
• Perform monitoring, sampling, and testing to validate equipment, systems, and processes per validation protocols.
• Provide technical support and data analysis for equipment, systems, and processes, including identification and monitoring of critical process parameters (CPPs).

• Support and execute cleaning validation test protocols and support documentation.

• Participate in change control activities, including documentation and execution of changes related to process and equipment updates.

• Support investigations into deviations, atypical results, and customer complaints, including data collection, root cause analysis, and CAPA implementation.

• Review and verify GMP documentation and data, ensuring accuracy and compliance with internal procedures.

• Perform statistical analysis of study data and present conclusions with clear, logical justifications in technical reports.

• Contribute to Annual Product Quality Reviews (APQRs) and ongoing process monitoring efforts.

• Maintain familiarity of current FDA and ICH requirements and cGMP regulations and complies with BPI safety requirements.

• Conduct departmental training as required.

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 managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Minimum Education / Experience

• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or related life science field; 1 year experience in pharmaceutical manufacturing or other regulated industry preferred.
• OR an Associate's degree in Chemistry, Engineering, or health-related fields w/at least 2 years' experience in pharmaceutical manufacturing or other regulated industry.

Other Knowledge, Skills and Abilities

• Computer Skills: To perform the essential functions of this position, basic computer skills are required.
• Foundational skills that are essential to this position include experience with word
• processing and spreadsheet software (e.g. Microsoft Word & Excel).
• Supplemental skills which are beneficial to this position include graphics (e.g. Microsoft PowerPoint) and database software.

Compensation range

$60,000 - $80,000

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies and experience. Bora Pharmaceuticals offers a competitive total rewards and 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 contributions

- Paid time off and flexible work arrangements

- Professional development opportunities

- Employee wellness programs and resources

- Employee Assistance Program and Mental Health Resources

Our 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. These values drive innovation, strengthen our teams, and ensure that we provide the best services to our employees and clients. Bora Pharmaceuticals Injectables, Inc. 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 Injectables, Inc. 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

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.