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Incubator Manager Jobs in Puerto Rico (NOW HIRING)

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

Validation Manager About Ocyonbio: OcyonBio is a biotechnology CDMO based in Aguadilla, Puerto Rico ... Operating as a cGMP incubator-style environment, OcyonBio enables robust CMC data generation to ...

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources ... Support chemical management, spill response, and emergency preparedness activities. * Perform ...

Biosimilar Sciences PR LLC

PR · On-site

$18.50 - $25.50/hr

  • Medical

  • Dental

  • Vision

We behave more like a cGMP incubator space with full regulatory systems capabilities and resources ... management of facility systems, utilities, and infrastructure. Responsibilities Maintenance ...

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

We operate as a cGMP incubator environment with full regulatory systems capabilities and resources ... Manage and organize the CEO's calendar, meetings, and appointments. * Coordinate corporate lunches ...

Biosimilar Sciences PR LLC

PR · On-site

$17.75 - $24.25/hr

We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources ... This role reports to the Facility Utility Manager. Responsibilities · Operate and maintain HVAC, ...

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources ... Lead and oversee analytical method development, qualification, validation, and lifecycle management ...

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

We operate as a cGMP incubator environment with full regulatory systems capabilities and resources ... Monitor hazardous waste management, chemical handling, and emergency preparedness programs.

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

We operate as a cGMP incubator environment with full regulatory systems capabilities and resources ... Familiarity with risk management tools and structured problem-solving methodologies preferred.

Biosimilar Sciences PR LLC

PR · On-site

Operating as a cGMP incubator, OcyonBio maintains robust quality systems, regulatory oversight, and ... Technical & Professional Competencies · Ability to apply Quality Risk Management (ICH Q9 ...

Biosimilar Sciences PR LLC

PR · On-site

We operate as a cGMP incubator environment with full regulatory systems capabilities and resources ... Effective time management and organizational skills. * Team-oriented mindset with the ability to ...

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources ... management, and coordination with vendors and service providers. * Ensure tools, test equipment ...

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

We operate as a cGMP incubator environment with full regulatory systems capabilities and resources ... management and system adoption across the organization Experience and Education · Bachelor ...

All JobsIncubator JobsIncubator Manager JobsIncubator Manager Jobs in Puerto Rico

Incubator Manager information

What does an incubator manager do?

An Incubator Manager oversees the operations of a business incubator, supporting startups and early-stage companies by providing mentorship, resources, and networking opportunities. They develop programs, manage facilities, and connect entrepreneurs with investors and industry experts. Their goal is to help startups grow sustainably by offering strategic guidance and access to essential business tools. Additionally, they track performance metrics and ensure that the incubator meets its mission of fostering innovation and economic development.

What are the key skills and qualifications needed to thrive as an incubator manager?

To thrive as an Incubator Manager, you need expertise in business development, program management, and entrepreneurial support, usually backed by a degree in business, innovation, or a related field. Familiarity with customer relationship management (CRM) systems, financial modeling tools, and performance tracking software is typical, along with certifications in project management or innovation leadership. Strong interpersonal skills, mentorship abilities, and strategic networking help set outstanding candidates apart. These capabilities ensure you can effectively guide startups, coordinate resources, and foster a thriving entrepreneurial ecosystem.

What are the typical challenges an incubator manager faces and how can they prepare for them?

Incubator Managers often encounter challenges such as balancing the diverse needs of startups, securing funding or sponsorships, and maintaining engagement across multiple stakeholders. To prepare, developing strong organizational and communication skills is crucial, as is gaining experience in entrepreneurship or startup ecosystems. Managers may also need to adapt to rapid changes in program direction or industry trends. Successful Incubator Managers proactively build networks and seek ongoing professional development to address these evolving challenges effectively.

What job categories do people searching Incubator Manager jobs in Puerto Rico look for?

The top searched job categories for Incubator Manager jobs in Puerto Rico are:

Incubator Manager jobs near you

Validation Manager

Biosimilar Sciences PR LLC

PR • On-site

Full-time

Medical, Dental, Vision

Re-posted 24 days ago

Job description


Job Title: Validation Manager


About Ocyonbio:

OcyonBio is a biotechnology CDMO based in Aguadilla, Puerto Rico, providing flexible cGMP facilities and integrated services to accelerate the development, manufacturing, and commercialization of biologics, cell & gene therapies, and advanced pharmaceutical products. Operating as a cGMP incubator-style environment, OcyonBio enables robust CMC data generation to support global regulatory submissions. We are committed to fostering an inclusive, respectful workplace where integrity, collaboration, and technical excellence are core to everything we do.


Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

Job Overview:

OcyonBio is seeking a Validation Manager to establish, lead, and govern the site Validation Program, including full ownership of the Site Master Validation Plan (SMVP). This role is responsible for ensuring that facilities, utilities, and manufacturing equipment are initially qualified, periodically requalified, and maintained in a validated state throughout their lifecycle in a multi-client CDMO environment.

The Validation Manager provides both hands-on technical leadership and strategic oversight, leading teams of company employees and contract personnel, and serving as the validation subject matter expert during regulatory inspections and client audits.

The Validation Manager is also expected to actively and continuously leverage AI-enabled tools and digital technologies to improve validation planning, execution, documentation quality, trend analysis, and inspection readiness, while ensuring full compliance with cGMP and data integrity requirements.


Key Responsibilities:

Validation Program & Governance

  • Establish, lead, and maintain the sitewide Validation Program
  • Develop, approve, and govern the Site Master Validation Plan (SMVP)
  • Ensure lifecycle validation control from design and commissioning through operation, requalification, and decommissioning
  • Coordinate initial qualification, periodic requalification, and change-driven revalidation activities

Facility & Utility Qualification

  • Lead validation and qualification of:
    • Cleanrooms and HVAC systems
    • WFI, purified water, clean steam, and compressed gas systems
    • Environmental monitoring systems
  • Implement risk-based commissioning and qualification (C&Q) approaches in accordance with ASTM E2500 and ISPE guidelines
  • Ensure facility systems remain in a validated state and inspection-ready

Equipment Startup & Qualification

  • Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment, including:
    • Sterile filling lines, autoclaves, incubators, refrigerators, and freezers
    • Bioreactors, chromatography skids, and single-use systems (SUS)
    • Solid dosage equipment (granulators, tablet presses, coating systems)
  • Oversee FAT/SAT planning and execution
  • Approve IQ/OQ/PQ protocols, reports, and traceability matrices

Team & Resource Leadership

  • Lead validation activities performed by company employees and contract validation personnel
  • Build, train, and manage validation resources to support project and operational needs
  • Oversee vendor qualification and validation service providers

Digital Enablement & AI Utilization

  • Consistently use AI-enabled tools to enhance validation lifecycle activities, including protocol development, risk assessments, deviation analysis, trend identification, and continuous improvement
  • Apply AI tools to improve efficiency, consistency, and quality of validation documentation and data review
  • Ensure responsible and compliant use of AI technologies in alignment with cGMP, data integrity (21 CFR Part 11), and company policies
  • Identify and implement opportunities for AI and automation to strengthen validation processes while maintaining regulatory compliance

Compliance & Inspection Readiness

  • Ensure compliance with FDA, EMA, MHRA, WHO, and ICH Q7–Q10 requirements
  • Serve as Validation SME during regulatory inspections and client audits
  • Lead deviation investigations, impact assessments, and CAPAs related to validation activities
  • Ensure data integrity compliance, including 21 CFR Part 11

Cross-Functional Collaboration

  • Partner with Engineering, Facilities, Quality, Manufacturing, and external vendors to ensure seamless project execution
  • Support technology transfers, facility expansions, and new client onboarding
  • Train operations and quality personnel on validation expectations, procedures, and digital tools


Qualifications:

Education & Experience

  • Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline
  • 5+ years of progressive validation experience in pharmaceutical, biotech, or CDMO environments
  • Demonstrated experience leading site-level validation programs and supporting regulatory inspections


Technical Expertise

  • Cleanroom and critical utility qualification
  • Aseptic processing and sterilization validation
  • Equipment commissioning and lifecycle validation
  • Risk-based validation (ASTM E2500)
  • Familiarity with automation systems (PLC/SCADA), ISPE Baseline Guides, and data integrity requirements
  • Demonstrated ability and willingness to continuously adopt and use AI-enabled tools in GxP-regulated environments


Leadership & Soft Skills

  • Strong technical writing and documentation skills
  • Excellent problem-solving and decision-making abilities
  • Effective communicator with strong cross-functional collaboration skills
  • Ability to lead in a fast-paced, multi-client CDMO environment


Preferred Qualifications

  • Lean Six Sigma, ASQ CQE, or ISPE certification
  • Experience with EU GMP Annex 1 (Sterility Assurance)
  • Hands-on exposure to single-use bioprocessing and viral vector manufacturing
  • Experience implementing or using AI tools within regulated GxP environments


Working Conditions

  • Work in classified cleanroom environments with aseptic gowning
  • Travel may be required for FAT/SAT, vendor audits, and client engagements
  • Flexibility to support extended hours or weekends during critical validation phases

What we offer:

  • Competitive compensation and benefits
  • Health, dental, and vision insurance
  • Professional training and development opportunities
  • Eligibility for company stock option programs
  • Opportunity to help build and shape a growing CDMO


We Are An Equal Opportunity Employer
Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

To learn more about us, please visit our website: https://ocyonbio.com