Manufacturing Associate II, Buffer & Media Prep (3-6 Month Contract)

About the role

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. This role is focused on biologics manufacturing, specializing in preparation of buffers and media to support cell culture and purification teams.

Responsibilities

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale, or validation activities).
• Prepare buffers and media, perform weigh-and-dispense activities, and support manufacturing teams as needed.
• Supports monitoring and documentation of batch-related activities, including data entry in electronic systems, and completes required documentation in accordance with GDP and cGMP guidelines.
• Provide expertise as a SME as a part of training sessions for other team members.
• Communicate effectively with external stakeholders (e.g., auditors and global colleagues) and collaborate with cross-functional groups to support manufacturing operations.
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.).
• Experience with SAP and Master Control a plus.
• Proficient in performing SOP/MPR updates along with assisting with CAPAs and MOCs as needed.
• 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.
• Operate manufacturing process equipment to support various production steps.
• Maintain required training, including OJTs, RAs, RUs, Compliance Wire, and Workday assignments, in an up-to-date status.
• Create and revise controlled documents, including SOPs, MPRs, and forms with-in Master Control.
• Lead other technicians during operations when a Lead Operator or Supervisor is not available.
• Communicate effectively with cross-functional teams.
• Perform required SAP transactions accurately and in a timely manner.
• Order, receive, and distribute supplies to production areas as needed.
• Possess good knowledge of cGMP and cleanroom behavior.

Qualifications

• With high school diploma: Normally requires 2-4 years of related experience required or an associate degree in Life Sciences/Engineering field with 1-3 years of related experience.
• Biotech Certificate preferred.
• With bachelor's degree: Normally requires 1-2 years of related experience.
• Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military time.
• 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.
• Able 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.
• Good with Microsoft Office – Outlook, Word, Excel.
• Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Physical Requirements

• PPE as required.
• May require lifting amounts of 40 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.