Downstream Manufacturing Associate II

4 weeks ago

Milford, United States Rentschler Biopharma Full time

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1100 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together

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 perform various manufacturing production stepsKnowledge on initiating new revisions for proceduresProficient operating inside of a BSC, sampling, and performing with aseptic techniquesMonitor and record batch parameters, including computer data entryComplete relevant paperwork following GDP/GMP guidelinesTroubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management softwareOrder, receive and distribute supplies into production area as neededDemonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers. Participate in (and may lead, as requested) team meetings and facilitate multidepartment discussions.Convey information to external stake holders (auditors, global colleagues, etc.). Provide support for groups that support manufacturingParticipate on Continuous Improvement TeamsMay perform other duties as assigned (During Production Processing these activities may increase)Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, analytical equipmentFamiliar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)Such additional responsibilities as the Company may also assign

Qualifications

With high school diploma: 4+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferredWith Bachelor’s degree: Normally requires 2+ years of related experienceGood with Microsoft Office – Outlook, Word, ExcelProficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military timeAble to read and follow detailed written instructions and have good verbal/written communication skillsAble to write legibly and grammatically correct entries on recordsMust be able to author technical procedures and create forms.Good computer skills, knowledge of Microsoft Word, ExcelGood interpersonal skills and be able to work effectively and efficiently in a team environmentAbility 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

Personal Protective Equipment must be worn as requiredMay require lifting amounts of 25 lbsManufacturing operations tasks requires operator to regularly remain on feet for shiftPushing buffer containers ranging from 50L to 200LSitting for periods of 2 to 3 hoursAbility to work in a clean room environment and comply with hygiene standards and use of special garments. Additionally, personal protective equipment must be worn due to safety requirements

Physical Requirements

PPE as requiredMay require lifting amounts of 25 lbsManufacturing operations tasks requires operator to regularly remain on feet for shift.

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