Upstream Manufacturing Associate III (Contract - Overnight Pitman)

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 role will follow an overnight Pitman schedule, 6pm-6:30am.

Duties and Responsibilities

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).
  • Operate manufacturing process equipment to performvarious manufacturing productionsteps
  • Knowledge on initiating new revisions for procedures
  • Proficient operating inside of a BSC, sampling, and performing with aseptic techniques
  • Monitor and recordbatch parameters,including computer data entry. Completerelevantpaperwork following GDP/GMP guidelines
  • Troubleshoot process problemsand respond to alarms.Provide information for unplanned events, including entering dataintoevent management software
  • Order,receive and distribute suppliesinto production area as needed
• Demonstrate procedures as apartof training sessions forother team members;may schedule
  • departmentor processactivitieswhich couldinvolve coworkers.  Participate in (andmay lead, as requested) team meetings and facilitate multidepartment discussions
• Convey information to externalstakeholders (auditors, global colleagues,etc.). Provide support for groups that support manufacturing
• Participate on Continuous Improvement Teams
• May performother duties as assigned. (During Production Processing these activitiesmay increase)
  • Manufacturing operations tasks requires operator to regularly remain on feet for shift
  • Pushing buffercontainersranging from50Lto 200L
  • Sitting for periods of 2 to 3 hours
  • Demonstrated knowledge of CGMP manufacturing
  • Knowledge of laboratory and pharmaceutical production equipmentincluding but not limitedto: autoclaves,process tanks, chromatography skids and columns, analytical equipment
  • Proficiency in a variety of mathematicaldisciplines and ableto workwith both the metricand USAstandards of measurement,and military time
  • 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
• Such additional responsibilities as the Company may also assign

Qualifications

• Withhigh school diploma: Normally requires 7+ years ofrelated experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred
• WithBachelor’s degree: Normally requires 4+years ofrelated experience
• Good with Microsoft Office – Outlook, Word, Excel

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 - $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.