Manufacturing Sciences & Technology Associate I

Bora Pharmaceuticals; Rockville (MD); On-site; USD 64,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Professional development

Job summary

Bora Pharmaceuticals in Rockville, MD is seeking a Manufacturing Technology Associate I to support drug substance manufacturing operations across late-stage programs. You will collaborate with Manufacturing Operations and BioPharmaceutical Development to support tech transfers, process validations, and routine production at internal sites.

The role emphasizes investigations, data analysis, and continuous improvement, with a focus on cGMP compliance and cross-site collaboration across multiple

Qualifications

• Bachelor's degree in Chemical / Biochemical Engineering, Biology, Chemistry, Biochemistry or related life sciences or engineering field.
• Academic, internship, co-op or professional exposure to biopharmaceutical manufacturing and/or protein purification processes, incl. chromatography, titration and filtration.
• Experience with Deviation, CAPA and Change Control systems.

Responsibilities

• Leads investigations of deviations to determine root cause and product impact; develops corrective action plans.
• Performs detailed data analyses and root cause analyses to identify solutions to complex problems.
• Leads continuous process monitoring and applies statistical tools to improve productivity and robustness.
• Supports technology transfer activities between internal and external sites and partners.
• Authors change controls and coordinates implementation at facilities to improve processes.

Skills

Root cause analysis

Data analysis

Statistical tools

Cross-functional collaboration

Good communication

Documentation

Education

Bachelor's degree in Chemical / Biochemical Engineering

Biology / Chemistry / Biochemistry related field

Tools

Microsoft Office (Word, Excel, PowerPoint)

Job description

About Bora:

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from FirstinHuman through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purposebuilt for commercialization. Our inspectionproven, bicoastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job Summary:

The Manufacturing Technology Associate I provides technical support to biopharmaceutical drug substance manufacturing operations for MacroGenics' late-stage clinical and commercial programs. The position will work in partnership with Manufacturing Operations and BioPharmaceutical Development to support technology transfers, process and equipment validations, and routine manufacturing at internal sites.

Essential Functions:

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

Responsibilities and Job Duties

• Leads investigations of deviations to determine root cause and product impact. Develops recommendations and implements approved corrective action plans at cGMP manufacturing facilities.
• Performs detailed data analyses and root cause analyses to identify solutions to complex problems.
• Leads continuous process monitoring efforts and applies statistical tools to identify and improve productivity, efficiency, and robustness in manufacturing.
• Actively engages in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites.
• Supports continuous improvement and operational excellence methods and efforts to improve the overall productivity and efficiency of manufacturing operations.
• Authors change controls, supports selection of new equipment and materials, and coordinates their implementation at manufacturing facilities to improve existing and new processes.
• Supports technology transfer activities between internal and external manufacturing sites and corporate partners.
• Supports fit-to-plant projections and plans for new processes and implements processes in multiple manufacturing facilities.
• Collaborates with the Quality Assurance group to fulfill quality management goals and ensures the highest quality manufacturing processes.

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 & Skills:

Minimum Requirements

• Bachelor's degree in Chemical / Biochemical Engineering, Biology, Chemistry, Biochemistry or related life sciences or engineering field
• Academic, internship, co-op or professional exposure to biopharmaceutical manufacturing and/or protein purification processes, including column chromatography, titration and filtration (depth, membrane, ultrafiltration/diafiltration)
• Experience with Deviation, CAPA and Change Control systems

Knowledge, Skills and Abilities

• Solid understanding of overall manufacturing process, and technical knowledge of downstream unit operations
• Knowledge of current Good Manufacturing Practices and US/EU regulations
• Ability to critically analyze data for process performance to compile technical reports and other documentation
• Ability to collaborate with cross functional teams resulting in creative and positive outcomes
• Strong verbal, presentation and writing skills to communicate effectively internally and externally
• Excellent organizational skills, ability to prioritize multiple projects, and attention to detail
• Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
• Demonstrated ability to effectively present information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
• Displays a clear willingness to listen to others
• Solid proficiency in the use of Microsoft software (Word, Excel, PowerPoint)
• Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment

Salary Range:

$64,000-$85,000

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.