Biopharmaceutical Manufacturing Associate

Job Title: Biopharmaceutical Associate I

Location: Rockville MD 20850

Duration: Minium 12 months with possibility of extension up to 18 months (Opportunity to convert to an FTE)

Shifts:

Training Shifts

• First 6 Weeks
• Monday – Friday (8:00 – 5:00 PM)

After Training Shifts (24/7/365 Operations)

• Day Shift: 6:00 AM EST – 6:30 PM EST
• Night Shift: 6:00 PM EST – 6:30 AM EST
• Weekend: Rotating Biweekly Schedule
• One Week – 2 Days On, 2 Days Off, 3 Days On
• Other Week – 2 Days Off, 2 Days On, 3 Days Off

Job Purpose:

• The Rockville Biopharm site exists to produce and deliver biopharmaceutical drug substance of the highest quality in a safe, compliant, reliable, and cost-effective manner for their patients. The vison is to be wholly entrusted to make innovative, high-quality medicines by leveraging the best talent & technology, on a platform of continuous improvement to supply every patient, every time.

Key Responsibilities:

1. Preparation, cleaning, sterilization, batching, pasteurization, or filtration & delivery of media and solutions for cell culture & purification operations.
2. Perform the set-up, operation, cleaning, and break down of process equipment.
3. Perform sampling procedures on various analytical instruments to analyze cell culture, solution, and/or product concentration characteristics.
4. Operate Filter integrity equipment to confirm the integrity of filters pre & post use.
5. Perform process operations, equipment, and instrument monitoring & trending to enable proactive identification of issues to escalate and correct with applicable departments.
6. Set-up fixed & mobile process equipment and parts with CIP (Clean In Place) skids to carry out validated cleaning & sterilization processes.
7. Follow appropriate standard operating procedures (SOP’s), protocols, and batch records/logbooks to safely perform operations & document compliantly with good documentation and data integrity practices.
8. Follow all related safety policies and procedures and put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.

Education, Knowledge, Experience Required:

Education

• Minimum Level of Education Required- High School Diploma or Equivalency
• Preferred Level of Education- Bachelor of Science/Art/associate’s degree in Biological Sciences, Chemical Sciences, Engineering, or equivalent technical discipline.

Job Related Experience

• Minimum Level of Experience - 0-1 years of directly related Manufacturing experience in the pharmaceutical or biotechnology industry.

Compliance & Documentation

• Ability to follow detailed instructions and document accurately
• Practices good documentation and data integrity standards
• Adheres to safety procedures and promotes a strong safety culture

Communication & Teamwork

• Proficient in speaking, reading, writing, and understanding English.
• Strong verbal & written communication skills
• Demonstrated ability to work effectively in a team
• Willing & able to work 24/7 rotating shifts

Technology Tools

• General proficiency with Microsoft Office (Excel, Word, Outlook)
• Basic knowledge of ERP Systems (M-ERP) per global/local procedures
• Familiar with automation systems & emerging digital platforms.

Physical Requirements

• Able to lift & carry materials up to 50 lbs.