Sr Manager Inspection & Packaging

The Company

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.

OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

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

The Role: We are looking to add a Sr Manager Inspection & Packaging to the OcyonBio team who will be responsible for supervising, hiring, and developing staff. Ensuring operations uptime and activities are completed on time while maintaining safety, quality, and financial objectives. We have a strong internal team and looking to add a forward thinker and problem-solver who understands the unique needs of a growing professional services business.

• Manage all aspects the engineering functional area that provides technical, project, emergency response, troubleshooting and maintenance support for relevant equipment and/or systems.
• Monitor Inspection and Packaging equipment uptime ensure prompt response to adverse tendencies and maintain uptime in the upper 90%.
• Resolve engineering, manufacturing and production issues with plant manufacturing staff and other supporting teams.
• Ensure resources are allocated and well trained to support Inspection and Packaging Day to day operations and strategic roadmap.
• Ensure relevant equipment / systems reliability and maintenance / repair is accurately executed accordingly and explain intervention exercises and potential impact to other plant support teams.
• Ensure consistent global engineering and operational practices are implemented.
• Ensure functional area has the ability to internally manage its own Deviations, Change Control, CAPAs, EVs, ARMS and CDOCS documents (Quality System records & documents).
• Oversee the development, revision, review, and approval of all documents (SOPs, FORMS, Deviations, CAPAs, CC, etc) that are owned by the area.
• Develop functional area metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based off the benchmarking data.
• Maintain an environment that promotes functional area flexibility, consistent engineering practices, and efficient operations, which prepare us for current and future production demands.
• Provide technical direction and on-the-floor & hands–on support in complex troubleshooting exercises.
• Lead the development of Engineering’s long and short-term strategies, goals and objectives that ensure the department and plant achieves the company goals.
• Establish and communicate goals and objectives consistent with the plant business strategy.
• Develop Long-Range Planning (LRP) to maintain the highest level of support and improve operations productivity.
• Develop, control, maintain, track, justify and stay within the area budget.
• Collaborate with and serve as department liaison to support other functional areas.
• Resolve issues between manufacturing, quality and maintenance organizations.
• Ensure relevant practices (processes & methods) and policies align with external regulatory requirements and internal corporate and site guidelines and procedures.
• Connect with Regulatory Compliance and Quality Assurance to ensure the department stays in compliance and represent the functional area in regulatory audits.
• Assure the appropriate level of training is available and assigned for staff at all levels of the relevant functional area.
• Ensure safety goals are communicated and supported in alignment with ongoing plant safety programs.

Requirement:

• Requires a Master’s in Mechanical, Chemical or Electrical Engineering with 8+ years’ experience
• Solid experience with Packaging Technology and Combination Products.
• 8 to 10 years’ experience in Pharmaceutical or Medical Devices industry, including managerial and technical roles in the area of Packaging Technology and Devices.
• Strong knowledge in Combination Products operations and regulations.
• Prior experience in investigation, change control and risk management processes.
• Experience dealing with regulatory agencies and previous direct interaction with regulatory officials.
• Proficient English and Spanish communication skills

What we offer:

• Competitive salary (DOE).
• Health, dental, and vision benefits.
• Professional training and development opportunities.
• Opportunity to participate in the company stocks options program.

• Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
• Specific vision abilities required by this job include close vision requirements due to computer work
• Light to moderate lifting is required
• Moderate noise (i.e. business office with computers, phones, and printers, light traffic).
• Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

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.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

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