Manufacturing Associate – Formulation

ADP, Inc.; Aguadilla (PR); On-site; USD 25,000 - 39,000; Full time

Job summary

OcyonBio in Aguadilla, PR, is seeking a Manufacturing Associate – Formulation at levels I, II, III, or Senior to support startup manufacturing activities, including preparation, formulation, mixing, filtration, and transfer of sterile products.

The role requires strict adherence to cGMP, meticulous documentation, and the ability to work in cleanroom environments while collaborating with Manufacturing, Quality, Engineering, and Facilities to ensure readiness and continuous improvement.

Qualifications

• High school diploma or equivalent required; an associate or bachelor's degree in a related field is preferred.
• Previous experience in pharmaceutical manufacturing or regulated production environment is preferred.
• Entry-level candidates may be considered for Manufacturing Associate I positions.
• Placement at higher levels depends on experience and competencies.

Responsibilities

• Execute routine formulation operations including dispensing, solution preparation, mixing, filtration, and bulk transfer per SOPs and batch records.
• Prepare, weigh, dispense, and verify raw materials and drug substances for formulation activities.
• Operate and monitor formulation equipment such as mixing vessels, single-use systems, pumps, and filtration assemblies.
• Set up, clean, and changeover formulation equipment and related systems.
• Document batch records, equipment logs, and GDP-compliant paperwork accurately.

Skills

Pharmaceutical manufacturing

cGMP compliance

Formulation processes

Equipment operation

GDP documentation

Education

High school diploma or equivalent

Job description

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Manufacturing Associate – Formulation

Manufacturing Full Time Professional Aguadilla, PR, PR

3 days ago Requisition ID: 1070

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

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
• 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
• Participate in required training and qualification programs related to cGMP, formulation processes, contamination control, equipment operation, and manufacturing procedures.
• Demonstrate flexibility and a willingness to support additional manufacturing activities as operational needs evolve within a startup environment.
• Other duties and responsibilities may be assigned as needed.

What we want from you

We are looking for motivated, detail‑oriented, and dependable individuals with a strong interest in pharmaceutical manufacturing and formulation processes. Candidates with varying levels of education and experience are encouraged to apply, as the position may be filled at the Manufacturing Associate I, II, III, or Senior level.

The ideal candidate demonstrates discipline in following established procedures, a commitment to product quality and patient safety, and a willingness to develop technical skills in a highly regulated manufacturing environment.

Basic Qualifications:

• High school diploma or equivalent required; an associate degree, bachelor's degree, or technical education in biotechnology, pharmaceutical manufacturing, chemistry, biology, engineering technology, or a related field is preferred.
• Previous experience in pharmaceutical manufacturing, biotechnology, medical device manufacturing, or another regulated production environment is preferred.
• Entry‑level candidates with relevant technical education or training may be considered for Manufacturing Associate I positions.
• Placement at the Manufacturing Associate II, III, or Senior level will depend on relevant industry experience, demonstrated technical competencies, and the ability to perform manufacturing activities with increasing levels of independence and responsibility.
• Ability to follow written manufacturing procedures, equipment operating instructions, and established 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 associated with manufacturing operations, including weighing, measurements, and solution preparation.
• Ability to work independently and collaboratively in a team‑oriented manufacturing
• Ability and willingness to perform activities within classified cleanroom environments, including wearing required gowning and personal protective equipment (PPE).
• Ability to perform physical activities associated with manufacturing operations, including prolonged standing, walking, and handling of manufacturing materials and equipment.
• Flexibility to work different shifts, weekends, or extended hours based on manufacturing and operational requirements.

Preferred Qualifications:

• Previous hands‑on experience in pharmaceutical GMP manufacturing, particularly formulation, compounding, or solution preparation for sterile injectable products or biologics, is highly preferred.
• Experience operating pharmaceutical formulation equipment, including mixing vessels, single‑use systems, peristaltic pumps, filtration assemblies, and associated manufacturing equipment.
• Familiarity with pharmaceutical formulation processes, including raw material dispensing, solution preparation, mixing, filtration, and bulk product handling.
• Experience performing in‑process testing and sampling activities, including pH, conductivity, concentration, and other formulation‑related measurements.
• Knowledge of cGMP regulations, Good Documentation Practices (GDP), and standard operating procedures.
• Familiarity with cleanroom classifications, gowning procedures, and contamination control practices.
• Experience performing equipment setup, line clearance, cleaning, sanitization, and manufacturing changeover activities.
• Familiarity with batch record execution, process parameter monitoring, and routine
• Previous participation in equipment qualification, technology transfer, engineering runs, or process validation activities.
• Experience supporting equipment troubleshooting, training, mentoring, or technical leadership of manufacturing personnel is preferred for Level III and Senior positions.
• Strong problem‑solving skills, attention to detail, and a commitment to maintaining high quality and safety standards.
• Ability to learn new manufacturing processes and equipment quickly and adapt to changing operational priorities.

Why OcyonBio

At OcyonBio, you will have the opportunity to contribute directly to the establishment and operation of modern pharmaceutical formulation and sterile drug product manufacturing capabilities. As part of a growing organization, you will gain valuable hands‑on experience in pharmaceutical formulation, biologics manufacturing, advanced manufacturing technologies, equipment qualification, and GMP operations while working alongside experienced industry