Lab Scale Operator

POSITION SUMMARY: Piramal Pharma Solutions Riverview facility (Ash Stevens, LLC) is seeking a qualified Lab Scale Operator to join our Production team. The Lab Scale Operator will contribute to the development and scaled up laboratory production of early stage active pharmaceutical ingredients (API) and intermediates and production of approved APIs in a safe and efficient manner that is compliant with current procedures and clients expectations. This position may also be involved in plant scale operations as required.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.

Key responsibilities.

• Conduct laboratory manufacturing following the current good manufacturing practices (cGMP) principles.
• Execute ADC manufacturing processes in strict accordance with safety regulations, industry best practices, and companies policies.
• Set up appropriately scaled glassware and conduct preparative scale (10 mL to 100 L or higher) organic chemistry operations including production unit operations such as charging liquids and solids to a vessel, filtration, distillation, drying, and packaging.
• Document observations from experiments in notebooks and complete production related documentation.
• Dismantle, clean, and reassemble and set-up equipment and complete related documentation.
• Consult with scale-up team members to resolve chemistry and/or equipment issues that may arise during production.
• Conduct use tests and additional laboratory experiments as directed by the PD Manger
• Maintain cleanliness and routine maintenance of the work area and equipment items within the working environment.
• Sample production batches and raw materials to support laboratory activities.
• Control the inventory of basic raw materials, consumables, and wastes within the immediate working environment.
• Collaborate on the creation and revision of unit documentation (SOP's, Batch Records, Cleaning Documents).

Education and Experience.

• BS Chemistry or equivalent.
• 0-2 years experience in process development and/or production position within the pharmaceutical or fine chemical industry is highly desired.
• Solid understanding of downstream processing, with academic or internship exposure to chromatography (Normal/Reverse Phase) and crystallization is highly desired.

Job Competencies.

• Understanding of organic chemistry principles and nomenclature.
• Mechanical skills in assembly and use of laboratory equipment and aides, as well as troubleshooting skills for all equipment.
• Full, independent user of applicable software systems including but not limited to Trackwise, SAP, MasterControl.
• Ability to interact effectively within all levels of the company.
• Self-starter with ability to recognize tasks that needs to be completed and to adjust schedules in order to meet commitments.
• Excellent record-keeping and communication skills.
• Knowledge of job related regulatory requirements (cGMP, OSHA, and EPA) and general knowledge as they apply to the facility as a whole.
• Must be able to pass a respirator fit test.