Downstream Manufacturing Associate III (1st Shift - Wed-Sat)

About the role

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals.

Responsibilities

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).
• Strong knowledge and understanding of manufacturing process and equipment to perform various production steps.
• Ability to train employees.
• Maintain and record batch parameters, including computer data entry; complete relevant paperwork following GDP/GMP guidelines; perform mathematical calculations related to production processes.
• Initiate new documents for procedures; may make minor revisions to existing documents.
• Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies.
• Initiate and troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software.
• Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution.
• Order, receive and distribute supplies into production area as needed.
• Push buffer containers ranging from 50L to 200L.
• Sit for periods of 2 to 3 hours.
• Convey information to external stakeholders (auditors, global colleagues, etc.).
• Oversee support for groups that support manufacturing (such as external cleaners, etc.).
• Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.).
• Provide knowledge in areas of training process improvements.
• Such additional responsibilities as the Company may also assign.

Requirements

• High school diploma: 6+ years of related experience required or an associate degree in Life Sciences/Engineering field; biotech Certificate preferred.
• Bachelor’s degree: 4+ years of related experience.
• Demonstrated knowledge of cGMP manufacturing.
• Knowledge of laboratory and pharmaceutical production equipment.
• Able to read and follow detailed written instructions and have good verbal/written communication skills.
• Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms.
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.).
• Good computer skills, knowledge of Microsoft Word, Excel.
• Able to work effectively and efficiently in a team environment.
• Able to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule.
• Ability to work in a clean room environment and comply with hygiene standards and use of special garments; additionally, personal protective equipment must be worn due to safety requirements.

Qualifications

• High school diploma: 6+ years of related experience required or an associate degree in Life Sciences/Engineering field; biotech Certificate preferred.
• Bachelor’s degree: 4+ years of related experience.
• Demonstrated knowledge of cGMP manufacturing.
• Knowledge of laboratory and pharmaceutical production equipment.
• Able to read and follow detailed written instructions and have good verbal/written communication skills.
• Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms.
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.).
• Good computer skills, knowledge of Microsoft Word, Excel.
• Able to work effectively and efficiently in a team environment.
• Able to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule.
• Ability to work in a clean room environment and comply with hygiene standards and use of special garments; additionally, personal protective equipment must be worn due to safety requirements.

Skills

• Experience in GMP downstream manufacturing; especially with TFF, Chromatography systems and purification of Mabs.
• Experience with troubleshooting of the equipment and of process.
• Excellent in clinical manufacturing.

Benefits

The salary pay range is subject to change and may be modified at any time.

Pay

$36/hr - $46/hr

Schedule

1st Shift 4/3 schedule, 6am-6:30pm, Wed-Sat (working every other Wednesday)