Downstream Manufacturing Associate III (Wed-Sat 4/3 Overnight Shift, 6p-6:30a)

Advancing medicine to save lives. Together. 

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.  

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 a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.  

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. 

This position will follow an Overnight 4/3 schedule, 6pm-6:30am, Wed-Sat (working every other Wednesday).

Key Experience for Manufacturing Associate, Downstream

• Experienced in GMP downstream manufacturing; especially with TFF, Chromatography systems and purification of Mabs
• Specific equipment/systems that we are using include, Akta ready, Akta Process, XDUos buffer systems and disposable technology systems
• Must have experience with troubleshooting of the equipment and of process and excellence in clinical manufacturing
• Characteristics: 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.  Could train newer operators once up to speed.
• 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 andequipment to performvarious productionsteps.
  • Ability to train employees.
  • Subject matter expert operating production equipment,as needed.
  • Monitor and recordbatch parameters,including computer data entry. Completerelevantpaperwork following GDP/GMP guidelines.Perform mathematicalcalculationsrelated to production processes.
  • Initiate new documents for procedures;maymake minorrevisions to existing documents.
  • Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies.
  • Troubleshoot process problemsand respond to alarms.Provide information for unplanned events, including entering dataintoevent 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 suppliesinto 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 externalstakeholders (auditors, global colleagues,etc.). Oversee support for groups that support manufacturing (suchas external cleaners,etc.).
• Lead Continuous Improvement Teams (such as5S, Gemba, OMT,etc.).
• Demonstrate procedures as apartof training sessions forother team members;may schedule departmentorprocessactivitieswhich couldinvolve 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

• Withhigh school diploma: Normally requires 3-6 years ofrelated experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred
• WithBachelor’s degree: Normally requires 1-4years ofrelated experience
• Demonstrated knowledge of CGMP manufacturing.
• Knowledge of laboratory and pharmaceutical production equipment.
• Abletoread and follow detailedwritteninstructionsandhave good verbal/written communicationskills.
• Abletowrite legibly and grammatically correct entries on records. Must beable toauthor technical procedures and create forms.
• Familiarwith standard troubleshooting approaches (problemstatement, root cause analysis, corrections, etc.)
• Good computer skills, knowledge of MicrosoftWord,Excel.
• Good interpersonal skills and beable to workeffectivelyand efficientlyin ateam environment.
• Ability to meet schedule required; this positionmay include shift,weekend, holiday workand overtimeat times,asdictatedby the 365-dayperyear production schedule.
• Ability to workin a clean roomenvironment and comply withhygiene standards and use ofspecial garments.Additionally, personal protective equipment mustbeworndue 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.

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Base Pay Range

$36/hr - $45/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.