Sr Manager Manufacturing Formulation and Fill

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 an Sr Manager Manufacturing Formulation and Filling

to the OcyonBio team who will oversee several the manufacturing functions including plans, directs and co-ordinates company’s manufacturing preparation, formulation and filling units, through subordinates, and in conjunction with other professionals internal and external to the company, formulate and fill drug product consistent with regulatory, sales and profitability requirements. 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.

Duties and responsibilities:

• Consistency with corporate and Operations department strategic planning processes
• Executes against master production schedule and other plans to achieve production objectives.
• Budgets and controls the financial, human and technical resources of the Filling operations; and develops and implements measures that provide feedback on Filling performance.
• Maintains effective working relationships with professionals, internal and external, including all government agency and department stakeholders and the general public, by projecting a positive personal and corporate image through appropriate behaviors.
• Aligns with the Supply Chain and Engineering teams to optimize Filling manufacturing performance, develops manufacturing improvement projects and leads their implementation and monitors the effectiveness of such strategies and plans to achieve management objectives.
• Develops and maintains Filling manufacturing KPIs, utilizes management systems, and operating processes that adhere to internal and external quality, compliance and reporting requirements.
• Recommends and, as approved, ensures changes to the structure and organization of tasks to ensure efficient achievement of accountabilities and goals and to provide flexibility to quickly capitalize on business opportunities.
• As required, participates on internal audit and continuous improvement teams.
• Participates in the review and analysis of potential contract manufacturing contracts.
• Ensures the initial and continuing training of the departmental personnel is conducted and adapted according to need.
• Ensures the safety and security of the departmental personnel, premises, and equipment.
• Ensures adequate resources are budgeted for and administrative controls are adhered to.
• Ensures every effort is made to complete annual goals that are agreed to with reporting manager.
• Ensures that production records are evaluated and approved by an authorized person before they are sent to the Quality Assurance Department.
• Ensures SQDEP KPIs are set, monitored, and actively addressed.
• Accountable for ensuring compliance with the requirements of current Good Manufacturing Practices (cGMP).
• Accountable for providing adequate resources through staffing solutions; this includes approval, selection, and monitoring of contractors/analysts.
• Performs or delegates the initial and continuing training of personnel.
• In charge of regulating Camden’s’ Filling manufacturing procedures/processes and assessing appropriate changes before implementation. Also responsible for having controlled, written responsibilities for the Filling department.
• Establishes, implements, and maintains departmental procedures consistent with company policies and standards for hygiene, safety, and security to assure compliance with applicable regulations, guidance documents, and industry best practice.
• Identifies, investigates, and reports to management issues which may affect product Safety, Quality, Delivery, Economics and People (SQDEP).
• Possesses authority to delegate above tasks to trained members of the management team.
• Other duties will be assigned, as necessary.

Requirement:

• Requires a Master’s in Mechanical, Chemical or Electrical Engineering with 8+ years’ experience
• Biotech/pharma industry experience is strongly preferred
• Advanced Excel, Project, Visio and Office application skills required
• Understanding of contemporary sterile drug product filling and manufacturing process, systems, controls, and regulations is a core requirement.
• Strong communication skills are required.
• Strong writing and communication skills and the ability to work independently.
• High level of attention to detail, excellent verbal and written communication skills required.
• Ability to multitask, handle changing priorities, tight deadlines and the ability to work outside one’s comfort zone.
• Demonstrates high level of maturity, self-motivation, and team-orientation.

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.

Working conditions:Physical RequirementsOFFICE POSITION - While performing the duties of this job the employee is required to:

• 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