Upstream Manufacturing Associate III (Wed-Sat, 7a-5:30p)

Rentschler Biopharma; Milford (MA); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading contract development and manufacturing organization is seeking an Upstream Manufacturing Associate III to support bioproduction efforts. Candidates should have at least 4-6 years of relevant experience, with strong knowledge of CGMP manufacturing processes and equipment. Responsibilities include monitoring production, training new employees, and leading continuous improvement efforts. The position requires adherence to safety and hygiene standards. Join a collaborative team dedicated to advancing medicine.

Qualifications

• 6+ years of related experience or an Associate’s Degree in Life Sciences/Engineering for high school diploma holders.
• 4+ years of related experience for bachelor’s degree holders.
• Familiar with standard troubleshooting approaches including root cause analysis.

Responsibilities

• Perform operations applicable to commercial scale production.
• Train employees and serve as a subject-matter expert.
• Monitor and record batch parameters following GDP/GMP guidelines.
• Lead Continuous Improvement Teams and facilitate cross-department discussions.

Skills

Knowledge of CGMP manufacturing

Ability to read and follow detailed instructions

Good verbal/written communication skills

Good computer skills: Microsoft Word, Excel

Good interpersonal skills

Education

High school diploma or Associate’s Degree in Life Sciences/Engineering

Bachelor’s Degree

Tools

Laboratory and pharmaceutical production equipment

Job description

Upstream Manufacturing Associate III (Wed‑Sat, 7a‑5:30p)

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We develop best‑in‑class solutions for bioprocess development and the production of complex biopharmaceuticals. Our mission is to advance medicine to save lives, fostering a collaborative, open‑minded team culture.

Duties and Responsibilities

• Perform operations applicable to commercial scale product, development studies, clinical scale, or validation activities.
  • Strong knowledge and understanding of manufacturing processes and equipment to perform various production steps.
  • Ability to train employees and serve as a subject‑matter expert on production equipment.
  • Monitor and record batch parameters, perform mathematical calculations, and complete relevant paperwork following GDP/GMP guidelines.
  • Initiate new documents for procedures; may make minor revisions to existing documents.
  • Work with support teams on event investigations, inventory cycle counts, and discrepancies.
  • Troubleshoot process problems, respond to alarms, and enter data into event management software.
  • Oversee training of new employees, tracking training requirements to ensure completion prior to process execution.
  • Order, receive, and distribute supplies to the production area as needed.
  • Pushing buffer containers ranging from 50 L to 200 L.
  • Sitting for periods of 2 to 3 hours.
  • Knowledge of laboratory and pharmaceutical production equipment (autoclaves, process tanks, chromatography skids and columns, analytical equipment).
• Convey information to external stakeholders (auditors, global colleagues, etc.) and oversee support for groups that support manufacturing.
• Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.).
• Demonstrate procedures as part of training sessions for team members; schedule department or process activities involving coworkers; lead team meetings and facilitate cross‑department discussions.
• Provide knowledge in training process improvements.
• Such additional responsibilities as the company may also assign.

Qualifications

• For high school diploma holders: 6+ years of related experience or an Associate’s Degree in Life Sciences/Engineering. Biotech Certificate preferred.
• For bachelor’s degree holders: 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; author technical procedures and create forms.
  • Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.).
  • Good computer skills: Microsoft Word, Excel.
  • Good interpersonal skills: work effectively in a team environment.
  • Ability to meet schedule requirements; may include shift, weekend, holiday work, and overtime as dictated by a 365‑day production schedule.
  • Ability to work in a clean room environment and comply with hygiene standards and use of special garments; personal protective equipment must be worn due to safety requirements.

Working Conditions and Physical Requirements

• 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 require the operator to regularly remain on feet for the shift.

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Research, Analyst, and Information Technology

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