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Central Services Manufacturing Associate III

4 months 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)Strong knowledge and understanding of manufacturing process and equipment to perform various production stepsSubject matter expert operating production equipment, as neededMonitor and record batch parameters, including computer data entryComplete relevant paperwork following GDP/GMP guidelinesPerform mathematical calculations related to production processes.Initiate new documents for procedures; may make minor revisions to existing documentsWork with support team on all necessary event investigations and inventory system cycle counts and discrepanciesTroubleshoot process problems and respond to alarmsProvide information for unplanned events, including entering data into event management softwareOversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process executionOrder, receive and distribute supplies into production area as neededKnowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, analytical equipmentConvey information to external stake holders (auditors, global colleagues, etc.)Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.)Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkersLead team meetings and facilitate multidepartment discussionsProvide knowledge in areas of training process improvementsSuch additional responsibilities as the Company may also assign

Qualifications

With high school diploma: 6+ years of related experience required or an Associate’s Degree in Life Sciences/Engineering field; biotech Certificate preferredWith Bachelor’s degree: 4+ years of related experienceDemonstrated knowledge of CGMP manufacturingKnowledge of laboratory and pharmaceutical production equipmentAble to read and follow detailed written instructions and have good verbal/written communication skillsAble to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create formsFamiliar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)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

Normal office working conditions: computer, phone, files, fax, copierPersonal 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

Physical Requirements

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