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Downstream Manufacturing Supervisor (Mon-Fri, 3rd Shift)

Rentschler Biopharma Inc.
Milford, MA
  • Posted: over a month ago
  • Full-Time
Job Description

About Rentschler Biopharma

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO), focused exclusively on client projects. From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. In order to offer best-in-class formulation development along the biopharmaceutical value chain, the company has entered a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned company with 1,000 employees.

Job Summary

We are recruiting for a proactive, strategic, and “hands-on” Supervisor, Manufacturing – Downstream. This position is responsible for overseeing daily activities on the designated shift for Downstream operations (purification, formulation, etc.) at the Milford MA biomanufacturing facility. In addition to overseeing the daily activities of the associates on the shift, the hands-on Supervisor will work alongside the associates executing manufacturing operations and batch records. This position will assure that the entire team is in strict compliance with current Good Manufacturing Practices (cGMP), environmental health and safety guidelines and any other regulations that may apply.

Downstream Manufacturing Supervisor (Mon-Fri, 3rd Shift) (23:30-8:00)

Key Experience/ Responsibilities for Shift Supervisor - Cell Culture

  • Hands-on supervision of manufacturing staff including hiring, coaching, training, goal setting, professional development, overall performance management and assessment.
  • Maintain personal training requirements and assure that each team member is adequately trained and documented for the execution of production SOP’s and MPR’s.
  • Subject Matter Expert in cGMP downstream manufacturing; especially with Chromatography, Column Packing, Tangential Flow Filtration (TFF), Ultrafiltration/Dia-filtration (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, dia-filtration 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 Ready Flux 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.
  • Author, revise and approve SOP’s, batch records, deviations and other documentation as required to ensure compliance.

  • 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 the shift, tracks completion of activities and reports on progress to downstream manufacturing manager.
  • Insure 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.
  • Leads or 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.
  • Warrant activities in the suite are conducted safely and in accordance with Safety procedures.

Ways of Working – Leadership Capabilities

The Manufacturing Supervisor is in the suite as a working manager of the team members on the shift that reports to them. The function of the job requires coordination of the team, responsibility for achieving team objectives, personnel training, capabilities and team morale. Additionally, this role is highly involved in communicating and coordinating with support organizations and leadership. The following leadership capabilities are required for this role.

Characteristics: adaptable to changes, works well on the floor alongside of manufacturing associates, cross functionally and with key stakeholders. Self-motivated, takes initiative and drives for solutions with the team.

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 responsible for assuring training of new employees and for developing new competencies in existing/ transferred personnel. This can be done personally or by scheduling of the site’s qualified trainers (QT). Must be experienced with training models and focused on building competencies and behaviors to elevate the performance of team members.

  • 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 employee’s performance on the shift.
  • Leads 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 Shift Supervisor from the Manufacturing Associate roles. However, the Shift Supervisor 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.
  • Pushing buffer containers ranging from 50L to 200L.
  • Sitting for periods of 2 to 3 hours.
  • 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

  • High school diploma & 5+ years of experience
  • Associate degree in Life Sciences/Engineering field & 3+ years of experience
  • Bachelor’s degree & 4+ years of experience
  • 2+ years’ experience as a Lead operator, supervisor or manager in Life Sciences.

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.
  • PPE as required

Physical Requirements

  • PPE as required.
  • May require lifting amounts of 25 lbs.
  • Manufacturing operations tasks requires operator to regularly remain on feet for shift.

Rentschler Biopharma Inc.

Address

Milford, MA
01757 USA

Industry

Manufacturing

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