Job Description

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.

Requirements

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.