Downstream Manufacturing Associate III (Overnight Wed-Sat Shift)

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. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM!

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.
• Monitor 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.
• Pushing buffer containers ranging from 50L to 200L.
• Sitting 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.
• Able 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.
• Able 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

• Adaptable to changes.
• Works well cross functionally and with key stakeholders.
• Self-motivated, takes initiative and drives for solutions with the team.
• Can lead in the absence of the manager.

Benefits

Base Pay Range: $36/hr - $46/hr
Disclosure Statement: Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.