Upstream Manufacturing Associate III (1st Shift, Wed-Sat) - Contract

Rentschler Biopharma Inc.; Milford (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biopharma company in Milford is seeking an Upstream Manufacturing Associate III for its production team. The role involves overseeing GMP manufacturing processes, training staff, and ensuring compliance with quality standards in a dynamic and professional environment.

Qualifications

• 6+ years experience with high school diploma or 4+ years with a Bachelor’s.
• Knowledge of cGMP manufacturing and pharmaceutical equipment.
• Good communication skills and ability to write technical procedures.

Responsibilities

• Perform GMP operations for various production steps.
• Train new employees and oversee their progress.
• Troubleshoot and resolve process and equipment issues.

Skills

GMP manufacturing

Troubleshooting

Communication

Teamwork

Attention to detail

Education

High school diploma

Associate’s Degree in Life Sciences/Engineering

Biotech Certificate

Bachelor’s degree

Tools

Microsoft Word

Microsoft Excel

Job description

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Upstream Manufacturing Associate III (1st Shift, Wed-Sat) - Contract

Bewerben locations Milford, MA, United States time type Vollzeit posted on Vor 7 Tagen ausgeschrieben job requisition id JR2228

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.

RentschlerBiopharmaSE 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 beschäftigtrund 1.400 Mitarbeiter und hat denHauptsitz in Laupheim, Deutschland, sowie einenStandort 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.

Key Experience for Manufacturing Associate, Upstream

• Experienced in GMP upstream manufacturing; especially with Suspension and adherent cell cultures, T-Flasks, roller bottles, bioreactors (rocker bioreactors 20/50L through 500L Single use bioreactors), and aseptic operations in BSC for the production of Mabs
• Specific equipment/systems that we are using include, Cytiva SUB’s, XDUO buffer SUM’s and disposable technology systems
• Must have experience with troubleshooting of the equipment and of process and excellence in clinical manufacturing
• Other possible responsibilities may include writing deviations/investigations and revising batch records if needed

Duties and 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
• Subject matter expert operating production equipment, as needed
• Monitor and record batch parameters, including computer data entry; complete relevant paperwork following GDP/GMP guidelines; p erform 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
• 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.); o versee 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: 6+ years of related experience required or an Associate’s Degree in Life Sciences/Engineering field. Biotech Certificate preferred
• With 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
• 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

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
• Pushing buffer containers ranging from 50L to 200L
• Sitting for periods of 2 to 3 hours
• Ability to work in a clean room environment and comply with hygiene standards and use of special garments

Physical Requirements

• PPE as required
• May require lifting amounts of 25 lbs
• Manufacturing operations tasks requires operator to regularly remain on feet for shift.