Mechanical Senior Engineering Operations Manager

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 1.400 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

Key Experience/ Responsibilities for Lead Manufacturing Operator - Downstream Subject Matter Expert in cGMP downstream manufacturing; especially with Chromatography, Column Packing, Tangential Flow Filtration (TFF), Ultrafiltration/Diafiltration (UF/DF), Nanofiltration, Formulation, Bulk Drug Substance Aliquoting A thorough understanding of purification key performance indicators, column volumes, retention time, resin loading, linear velocity, TFF membrane loading, diafiltration factor, LMM and the science behind the downstream production of mAb's Specific equipment/systems that we are using include Cytiva Single Use Mixers (100L, 200L, 500L, 1000L), Cytiva AKTA Ready chromatography skid, Cytiva AKTA ReadyFlux XL TFF, TCU's, BSC's, Millipore and Sartocheck integrity testers, and disposable technology systems. Must have a thorough understanding of the equipment and controls as this role will be the front-line troubleshooting and correction role for the shift. Must have experience with initiating, developing and revising SOP's and Batch records for downstream processes Thoroughly familiar with the identification of actions and results that are outside procedures and limits which require escalation through events and deviations; responsibilities include leading and completing investigations of root causes and formally documenting/writing deviations for such events in downstream Subject matter expert for materials and the ordering of materials in time to meet the schedule; participates in inventory cycle counts and resolution/ corrective actions for discrepancies Assures that SAP transactions for process orders are executed on time and works with supply chain to resolve any discrepancies Schedules daily activities for coworkers on shift, tracks completion of activities and reports on progress to manufacturing supervisor Assures that executed batch records are reviewed thoroughly and all entries are correct before turning over to QA for approval; works to resolve batch record entry issues before they are reviewed by QA Assures activities in the suite are conducted safely and in accordance with Safety procedures

Ways of Working - Leadership Capabilities Collaborates with and provides open, honest, technically accurate information to support teams (Eng, Fac, PS, QA, QC, SC) during scheduling meetings, event/deviation investigations and process/ equipment troubleshooting This position is the lead Qualified Trainer for new employees or for developing new competencies in existing/ transferred personnel. Must be experienced with training models and focused on building competencies and behaviors to elevate the performance of team members Oversees new employees training (as executed on the floor) to understand what new employees are trained to perform and can document in batch record, prevents task execution before training is documented Monitors team culture provides clarity to misinformation and legacy attitudes and behaviors Elevates issues early, presents issues with options for quick and compliant resolution Provides feedback and SME support for training department process improvements Provides feedback to supervisor/ manager on employees' performance on the shift Leads some team meetings and may facilitate multi-department discussions Supports a positive work environment that promotes inclusion and diversity

Standard Manufacturing Duties and Responsibilities for operators

The Key Experience and Ways of working distinguish the Lead Manufacturing Operator from the Manufacturing Associate roles. However, the Lead Operator is on the floor, operating the equipment and completing batch records alongside the manufacturing associates. The following manufacturing responsibilities are also performed: Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities) Perform, Monitor, Review, and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines Perform mathematical calculations related to production processes Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, analytical equipment Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.) Such additional responsibilities as the Company may also assign Proficient in BSC operations and aseptic technique

Qualifications With high school diploma: Normally requires 8+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred With Bachelor's degree: Normally requires +6 years of related experience 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. Must be able to author technical procedures and create forms Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.) Good computer skills, knowledge of Microsoft Word, Excel Good interpersonal skills and be able to work effectively and efficiently in a team environment 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 Ability 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 Proficient in BSC operations and aseptic technique

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 Pushing buffer containers ranging from 50L to 200L Sitting for periods of 2 to 3 hours

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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