What are the responsibilities and job description for the Upstream Manufacturing Associate III position at Rentschler Biopharma SE?
locations
Milford, MA, United States
time type
Vollzeit
posted on
Gestern ausgeschrieben
job requisition id
JR2421
Medizin vorantreiben, um Leben zu schützen. Gemeinsam.
Dank vieler Jahrzehnte Erfahrung und unserer Leidenschaft für das, was wir tun, leisten wir einen essenziellen Beitrag zur weltweiten Verfügbarkeit von Biopharmazeutika, auch und gerade für Patienten mit seltenen und schweren Erkrankungen.
Rentschler Biopharma SE ist ein führendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) und ausschließlich auf Kundenprojekte fokussiert. Wir bieten maßgeschneiderte Full-Service-Lösungen für die Bioprozessentwicklung und die Herstellung komplexer Biopharmazeutika. Als deutsches Familienunternehmen mit internationalem Footprint und globaler Reichweite verbinden wir Experten, Expertise und langjährige Erfahrung, um zusammen mit unseren Kunden beste Lösungen zu entwickeln.
Rentschler Biopharma beschäftigt rund 1.400 Mitarbeiter und hat den Hauptsitz in Laupheim, Deutschland, sowie einen Standort in Milford, MA, USA. Im Jahr 2024 haben wir uns dem Global Compact der Vereinten Nationen angeschlossen und unterstreichen damit unser Engagement für Nachhaltigkeit.
Als unabhängiges Familienunternehmen leben wir nach dem Motto: Many hands, many minds – ONE TEAM! Ein offenes, respektvolles Miteinander prägt unsere Arbeitswelt, in der Qualitätsbewusstsein, Sorgfalt und Verantwortung an erster Stelle stehen. Denn bei aller Vielfalt unserer Talente im Rentschler Team verfolgen wir gemeinsam einen Zweck: Medizin voranzutreiben, um Leben zu schützen.
This role will follow an overnight Pitman schedule, 5pm-5am.
Duties and Responsibilities
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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
- Subject matter expert operating production equipment, as needed
- Monitor and record 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
- 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
- Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment
- Convey information to external stake holders (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.)
- Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers; lead team meetings and facilitate multidepartment discussions
- Provide knowledge in areas of training process improvements
- Such additional responsibilities as the Company may also assign
Qualifications
- With high school diploma: Normally requires 6 years of related experience required or an Associate’s Degree in Life Sciences/Engineering field. Biotech Certificate preferred
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With Bachelor’s degree: Normally requires 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
- Good interpersonal skills and be able to work effectively and efficiently in a team environment
- Ability 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
Working Conditions
- Normal office working conditions: computer, phone, files, fax, copier
- Personal Protective Equipment must be worn as required
- May require lifting amounts of 25 lbs
- Manufacturing operations tasks requires operator to regularly remain on feet for shift
Physical Requirements
- PPE as required
- May require lifting amounts of 25 lbs
- Manufacturing operations tasks requires operator to regularly remain on feet for shift
Brauchen Sie Hilfe?
Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team:
welcome@rentschler-biopharma.com