Tier 1 – Formulation Technician I (Entry-Level)

• Adherence to safety protocols and proper use of PPE.
• Adherence to Good Documentation Practices and Current Good Manufacturing Practice regulations.
• Complete and maintain applicable training certifications.
• Proper time management, including arriving on time, observing appropriate breaks – including lunches – as well as minimizing overtime unless authorized by management.
• Any deviation from the assigned schedule must be communicated to management, including call-outs.
• Complete assigned tasks on production schedule in an efficient manner.
• Complete dispensing, formulation, filter integrity testing, sample submission and all other supporting processes per applicable batch records, procedures, or forms.
• Ability to properly enter cleanrooms, maintain gown certification requirements, and demonstrate proper cleanroom environment behavior – such aseptic technique.
• Operate and navigate software systems including but not limited to: LabVantage, PIMS, FactoryTalk, RMLA and EBR.
• Operate and navigate equipment such as balances, formulation tanks, filter integrity equipment, and pH meters.
• Coordinate and communicate with team members and other necessary departments in order to complete production tasks.
• Communicate shift activity as well as any obstacles, equipment issues, deviations, safety concerns or out of specifications to management and/or the appropriate personnel.
• Perform any other tasks as assigned by management or senior leadership.

Tier 2 – Formulation Technician II (Intermediate)

• Budesonide Tier I Training--Completion of Budesonide Tier I training to understand specific handling and formulation requirements.
• Formulation Expertise--Gaining specialized knowledge and skills in pharmaceutical formulation through education and hands-on experience.
• Portable and Large Tank Formulations--Skilled in preparing formulations using portable tanks and large-scale tanks to ensure batch accuracy and quality.
• SALTUS and MOBIUS Formulation Tanks--Experience operating and managing formulations in SALTUS and MOBIUS tanks, understanding their specific capabilities and protocols.
• Good Documentation Practices (GDP)--Adherence to GDP standards to maintain accurate, compliant documentation throughout manufacturing processes.
• Pre-weigh Procedures--Accurate pre-weighing of raw materials to ensure formulation consistency.
• Filter Testing--Conducting filter integrity tests to meet sterility and quality standards.
• pH Meter Calibration--Performing calibration and operation of pH meters to control formulation parameters effectively.

Nitrogen Sparge Application--Using nitrogen sparging techniques to reduce oxygen levels and enhance product stability

Tier 3 – Formulation Technician III (Advanced)

• Containment Box & Data Logger--Skilled in operating containment box used for pre-weighing raw materials under vacuum to minimize moisture exposure, along with using data loggers to monitor process conditions.
• Electronic Controlled Substance Waste Logbook--Maintain and manage accurate, compliant electronic records of controlled substance waste.
• Handling Controlled Substances --Thorough understanding of procedures for handling-controlled substances.
• BFS (Blow-Fill-Seal) Process--Understanding of how BFS technology integrates with formulation processes.
• Carboy Handling--Skilled in preparation and management of carboys used in formulation processes.
• Accuflux Filter Testing Unit--Proficient in operating the Accuflux system for filter integrity testing to ensure product sterility and quality.
• Portable Tank CEV Sampling and Submission--Competent in collecting samples from portable tanks following Controlled Environmental Validation (CEV) standards and submitting samples correctly.
• Portable Tank Filtration--Ability to perform filtration on portable tanks while ensuring sterility and product quality.
• Large Tank CEV Sampling and Submission--Skilled in CEV-compliant sampling from large tanks and proper sample submission procedures.
• Large Tank Filtration--Skilled in carrying out filtration processes on large tank formulations as part of daily manufacturing operations.
• Budesonide Tier II Training--Completion of Budesonide Tier II training, reflecting advanced knowledge in formulation.

Skills:

• Expertise regarding handling and mixing of chemicals through education and/or experience preferred.
• Strong attention to detail, math skills, and knowledge of the metric system.
• Ability and willingness to change direction and focus promptly to meet shifting organizational and business demands.
• Ability to manage multiple resources in a cGMP environment to ensure documented information is accurate, legible, contemporaneous, original, and attributable.
• Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting, walking, and hearing.
• Ability to pass required medical screenings to ensure safe handling of pharmaceutical raw materials used within the manufacturing process.
• Technicians are required to wear appropriate PPE and interpret documentation containing safety guidance.
• Ability to work individually and as part of a team in order to create and contribute to an environment that values people and encourages trust, teamwork, and open communication.
• Ability to effectively manage oneself, demonstrate integrity, be productive under pressure, and achieve developmental goals.
• Ability to communicate effectively to team members and superiors

Abilities:

• Ability to develop positive, professional relationships with senior leadership and peers in a heavily matrixed environment.
• Ability to handle contending priorities and managing partner expectations.
• Strong project management skills with ability to execute on short- and long-term deliverables.
• Ability to combine Industry knowledge to appropriately evaluate and resolve complex issues within a fast paced and changing business environment.
• Ability to objectively coach employees and management through complex, difficult, and emotional issues.
• Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law.

Tier I and II: High School Diploma or GED

Tier III: Minimum of High School Diploma or equivalent with Associate or Bachelor’s Degree preferred.

Working Conditions / Physical Requirements:

· This position requires bending, typing, lifting (up to 20 1bs.), standing, sitting and walking throughout the facility.