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, 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

environment.

• 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

manufacturing documentation.

• 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

professionals.