Manufacturing Associate – Formulation

Biosimilar Sciences PR LLC• Aguadilla, PR, PR, PR

5d•Onsite

About The Position

OcyonBio is hiring a Manufacturing Associate – Formulation at the I, II, III, or Senior level to support the start-up and ongoing operation of its pharmaceutical manufacturing capabilities in Aguadilla, Puerto Rico. The role executes formulation activities for pharmaceutical products, including biologics and sterile injectable drug products. The assigned level and degree of independence will depend on the candidate’s education, industry experience, technical knowledge, and demonstrated competencies. The position involves preparing, formulating, mixing, filtering, and transferring products in classified manufacturing environments. The associate follows cGMP requirements, approved SOPs, batch records, and contamination-control practices while supporting product quality and manufacturing readiness in a growing startup. The role also contributes to equipment qualification, engineering runs, technology transfer, process characterization, validation, and continuous improvement as operational needs require.

Requirements

High school diploma or equivalent required.
Ability to follow written manufacturing procedures, equipment operating instructions, and safety requirements.
Basic understanding of manufacturing processes, equipment operation, and quality requirements.
Strong attention to detail and ability to accurately complete manufacturing records and other required documentation.
Ability to perform basic mathematical calculations for weighing, measurements, and solution preparation.
Ability to work independently and collaboratively in a team-oriented manufacturing environment.
Ability and willingness to work in classified cleanrooms while wearing required gowning and personal protective equipment.
Ability to perform manufacturing-related physical activities, including prolonged standing and walking and handling manufacturing materials and equipment.
Flexibility to work different shifts, weekends, or extended hours based on manufacturing and operational requirements.
For placement at the Manufacturing Associate II, III, or Senior level, relevant industry experience, demonstrated technical competencies, and the ability to work with increasing independence and responsibility are required as applicable to the assigned level.

Nice To Haves

Associate degree, bachelor’s degree, or technical education in biotechnology, pharmaceutical manufacturing, chemistry, biology, engineering technology, or a related field.
Experience in pharmaceutical manufacturing, biotechnology, medical device manufacturing, or another regulated production environment.
Relevant technical education or training for entry-level Manufacturing Associate I candidates.
Hands-on pharmaceutical GMP manufacturing experience, particularly formulation, compounding, or solution preparation for sterile injectable products or biologics.
Experience operating formulation equipment such as mixing vessels, single-use systems, peristaltic pumps, and filtration assemblies.
Familiarity with raw material dispensing, solution preparation, mixing, filtration, and bulk product handling.
Experience with in-process testing and sampling, including pH, conductivity, and concentration measurements.
Knowledge of cGMP regulations, Good Documentation Practices, and standard operating procedures.
Familiarity with cleanroom classifications, gowning, and contamination-control practices.
Experience with equipment setup, line clearance, cleaning, sanitization, and manufacturing changeovers.
Familiarity with batch record execution, process parameter monitoring, and routine manufacturing documentation.
Participation in equipment qualification, technology transfer, engineering runs, or process validation.
Experience in equipment troubleshooting, training, mentoring, or technical leadership, particularly for Level III and Senior positions.
Strong problem-solving skills and ability to learn new processes and equipment quickly and adapt to changing operational priorities.

Responsibilities

Execute formulation operations, including material dispensing, solution preparation, mixing, filtration, and bulk product transfer, in accordance with approved SOPs, batch records, and cGMP requirements.
Prepare, stage, weigh, dispense, and verify raw materials, drug substances, and other formulation components.
Operate and monitor formulation equipment, including mixing vessels, single-use systems, balances, pumps, filtration assemblies, and associated manufacturing equipment.
Set up, assemble, disassemble, clean, and change over formulation equipment and manufacturing systems.
Carry out formulation activities within established process parameters, including mixing times, temperatures, and agitation speeds.
Perform routine in-process controls and sampling, including pH, conductivity, concentration, and other product-specific testing.
Support filtration activities, including filter assembly, setup, integrity testing, and transfer of formulated bulk solutions to downstream operations as applicable.
Transfer materials and products using approved procedures, ensuring proper handling, identification, and traceability.
Follow cleanroom gowning procedures, personnel and material flows, cleanroom behaviors, and contamination-control requirements.
Perform line clearance, verify equipment status, and prepare manufacturing areas before and after formulation operations.
Complete batch records, equipment logbooks, cleaning records, and other GMP documentation in accordance with Good Documentation Practices.
Monitor and document critical process parameters, equipment operating conditions, and manufacturing activities.
Support equipment commissioning, qualification, and manufacturing readiness, including approved protocols and operational testing.
Participate in engineering runs, process characterization, technology transfer, and process validation as required.
Report equipment malfunctions, process abnormalities, documentation discrepancies, and potential quality concerns to the Manufacturing Supervisor.
Collaborate with Manufacturing, Quality, Engineering, and Facilities to support production schedules, equipment readiness, and continuous improvement.
Support troubleshooting, training and mentoring of less experienced associates, and operational improvements as appropriate for the assigned level.
Participate in required training and qualification programs related to cGMP, formulation, contamination control, equipment operation, and manufacturing procedures.
Adapt to evolving operational needs and support additional manufacturing activities as required.