Manufacturing Associate – Formulation

Manufacturing Associate – Formulation (Levels I, II, III & Senior)

Location: Aguadilla, PR Company: OcyonBio

About OcyonBio

OcyonBio is a growing biopharmaceutical startup focused on building robust, compliant, and scalable GMP manufacturing capabilities. As an early-stage organization, we value technical rigor, accountability, and a hands-on culture where employees actively contribute to building systems, teams, and processes from the ground up.

What you will do

The Manufacturing Associate – Formulation will play an essential role in supporting the start-up and ongoing operation of OcyonBio's pharmaceutical manufacturing capabilities. This individual will be responsible for executing manufacturing activities associated with the preparation, formulation, mixing, filtration, and transfer of pharmaceutical products, including biologics and sterile injectable drug products.

This position is open to candidates at the Manufacturing Associate I, Manufacturing Associate II, Manufacturing Associate III, and Senior Manufacturing Associate levels. The appropriate level will be determined based on the candidate's educational background, relevant industry experience, technical knowledge, and demonstrated competencies. Responsibilities and level of independence will be aligned with the assigned position.

The role requires strong attention to detail, adherence to cGMP requirements, and a commitment to product quality and contamination control. The ideal candidate is a hands-on, motivated individual who can work effectively in classified manufacturing environments while contributing to the establishment of manufacturing processes and operational readiness in a startup organization.

Key responsibilities include:

• Execute routine manufacturing operations associated with pharmaceutical formulation, including material dispensing, solution preparation, mixing, filtration, and bulk product transfer in accordance with approved SOPs, batch records, and cGMP requirements.

• Perform the preparation, staging, weighing, dispensing, and verification of raw materials, drug substances, and other components required for formulation activities.

• Operate and monitor formulation equipment, including mixing vessels, single-use

systems, balances, pumps, filtration assemblies, and associated manufacturing

equipment.

• Perform equipment setup, assembly, disassembly, cleaning, and changeover activities

for formulation equipment and associated manufacturing systems.

• Execute formulation activities according to established manufacturing parameters,

including mixing times, temperatures, agitation speeds, and other process

requirements.

• Perform routine in-process controls and sampling activities, including pH, conductivity,

concentration, and other product-specific testing as required by approved procedures.

• Support filtration activities, including filter assembly, setup, integrity testing, and

transfer of formulated bulk solutions to downstream manufacturing operations, as

applicable.

• Perform material and product transfers using approved procedures, ensuring proper

handling, identification, and traceability throughout the manufacturing process.

• Follow established cleanroom gowning procedures, personnel and material flows,

cleanroom behaviors, and contamination control requirements.

• Execute line clearance, equipment status verification, and manufacturing area

preparation before and after formulation operations.

• Accurately complete manufacturing batch records, equipment logbooks, cleaning

records, and other required GMP documentation in accordance with Good

Documentation Practices (GDP).

• Monitor and document critical process parameters, equipment operating conditions,

and manufacturing activities to ensure compliance with established specifications.

• Support equipment commissioning, qualification, and manufacturing readiness

activities, including execution of approved protocols and operational testing.

• Participate in engineering runs, process characterization, technology transfer, and

process validation activities as required.

• Identify and promptly report equipment malfunctions, process abnormalities,

documentation discrepancies, or potential quality concerns to the Manufacturing

Supervisor.

• Collaborate with Manufacturing, Quality, Engineering, and Facilities personnel to

support production schedules, equipment readiness, and continuous improvement

initiatives.

• Support equipment troubleshooting, training and mentoring of less experienced

associates, and operational improvement activities as appropriate for the assigned

position level.

• Participate in required training and qualification programs related to cGMP, formulation

processes