Lead Bioprocess Associate - 2nd - Shift

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

Responsible for the manufacture of biopharmaceuticals, including bench top, scale up and pilot formulations; preparing and operating process equipment, handling materials, dispensing chemicals and interfacing with Maintenance, QA, QC and Tech Group in a cGMP environment. This position will support 2nd shift operations, working Monday-Friday-2pm-10:30pm.

Essential Functions

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

• Work under general supervision of Manufacturing Supervisor to produce parenteral drugs
• Perform compounding of pharmaceutical products following Production Batch Record.
• Perform and document developmental formulation batches as required.
• Responsible for performing bench-top, pilot, scale-up and verification batches.
• Maintain process equipment according to SOP's, which may include CIP and SIP of Formulation Tanks.
• Perform or verify calculations and measurements to ensure that batches made maintain consistent high-quality standards.
• Document activity, as required, in batch records and logbooks.
• Assist the Technical Transfer Group, Validation, and Engineering departments with the operation and execution of engineering projects.
• Interface with the Quality Assurance, Quality Control, Maintenance, and Materials Management departments to resolve production, supply, and equipment issues.
• Assist with the preparation of materials needed for Formulation.
• Comply with cGMP regulations; adhere to Bora's policies, SOP's and Batch Record directions.

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

• Certificate, Diploma, Degree or equivalent in Science, Engineering or related field preferred.
• 1-3 years' experience in biopharmaceutical or pharmaceutical cGMP manufacturing.
• Thorough knowledge of current Good Manufacturing Practices (GMP)
• The ability to work cross-functionally with multiple departments and excellent oral and written communication skills are required.
• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• Excellent documentation skills including comprehension, review and establishing Batch Production Records, SOP's, deviation & summary reports

Compensation range: 75,000 - 95,000

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.