Lead BioProcess Associate-2nd Shift

I. Job Summary

The Lead Bioprocess Associate position reports to Supervisor/Manager Manufacturing. Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. This role is responsible for cGMP environment. This role is 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 our 2nd shift, working 2pm-10:30pm, Monday - Friday.

Ii. Essential Functions

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

• Work under general supervision of Production Supervisor to manufacture parenteral drugs.
• Perform compounding of pharmaceutical products following Production Batch Record.
• Performs and documents developmental formulation batches as required.
• Responsible for performing bench-top, pilot, scale-up and verification batches.
• Edits/writes standard operating procedures as directed by the Production Supervisor.
• Review and revise procedures and documentation to ensure cGMP compliance.
• Maintains process equipment according to SOP’s, which may include CIP and SIP of Formulation Tanks.
• Performs or verifies calculations and measurements to ensure that batches made maintain consistent high-quality standards.
• Documents activity, as required, in batch records and log sheets.
• Assist the MS & T group, Validation and Engineering staffs 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 established company policies, SOP’s and Batch Record directions.
• Assist in clean room operations as needed.
• May be called upon to assist in general production activities when necessary.
  
  

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.

Iii. Minimum Education, Experience, Skills

• BA/BS in any field
• Or High School/AA with at least three-years of experience in a manufacturing or laboratory setting
  
  

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Compensation Range

$68,891.00 - $103,337.00

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