Vibalogics continues to become one of the world’s leading suppliers to the virotherapy markets. As a premier partner for biotechnology and pharmaceutical companies, we offer our customers a complete solution for the development and production of material for the testing of drugs for viro and gene therapy. We focus on the product groups of replication-capable viruses such as oncolytic viruses and viral vectors.
As a strongly growing and very ambitious contract development and manufacturing organization, we work according to the principles of Good Manufacturing Practices (GMPs). From our newly established headquarters in Massachusetts and well established facility in Cuxhaven, Germany, we serve customers in Europe, North America and Asia, thereby supporting the development of highly innovative drugs. Our customers include the world's largest pharmaceutical companies and numerous biotechnology firms.
Our employees are engaged and passionate about the company and the patients we indirectly serve. Our daily work is extremely varied and offers many opportunities for development.
If you are looking for a trusting, respectful and open environment where you can contribute to producing life changing virotherapies, let’s have a discussion.
The Senior Manufacturing Technician, Upstream will be responsible for supporting daily manufacturing activities per the weekly production calendar. Upstream Manufacturing performs small- and large-scale cell culture operations, harvest, tangential flow filtration and media makeup steps in a new manufacturing facility. Completion of assignments needed to execute a dynamic production schedule within the clean room cGMP facility at Vibalogics, a contract manufacturing company working in the biopharmaceutical industry. This individual will work with department leadership and other departments to complete assignments in a fast-paced and dynamic environment. This individual will set the example for a strong safety culture and will be mindful of all organizational policies and procedures.
ESSENTIAL JOB FUNCTIONS
- Day shift position with weekends and overtime as per business needs
- Ensure that manufacturing processes are performed according to applicable SOPs using qualified equipment
- Responsible for all setup and operations, and breakdown of all equipment
- Trains and develops junior staff on aseptic technique and filling machine operation
- Responsible for escalating any non-conforming events to the appropriate cross-functional stake holder
- Must be able to function independently or in a larger cross functional group.
- Can operate, troubleshoot, and maintain manufacturing equipment and see through the maintenance process using work orders.
- Conduct a daily walkthrough of the manufacturing facility to ensure status signs, logbooks and batch records are documented appropriately.
- Willingness to perform, monitor and train aseptic processing operations and can serve as the area expert in these activities.
- Conduct, coordinate and document quality/safety incidents and investigations, corrective, and preventive actions.
- Ensure the cleanroom is equipped with the necessary materials, tools, and equipment necessary.
- Maintain manufacturing records, complies with CGMPs and internal quality system requirements
- Works with Engineering, Materials Management, Quality Assurance and Validation to complete assignments, and ensure ongoing continuous improvement
- Oversee waste handling operations in accordance with company procedures
The individual selected for this role must excited by the opportunity of being part of a first-in-class operations function at the Boxborough facility. This individual should have thorough knowledge of GMP’s and a clear understanding of EH&S regulations that pertain to the operations function. This individual will collaborate with colleagues at all levels of the organization and support cross-functional collaboration.
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Skills and Teamwork – Ability to lead by example and work collaboratively
- Organizational Skills – Ability to prioritize and manage through complex processes/projects
- Detail-orientation - excellent written and verbal communication skills required.
- Conceptual Thinking - Must be able to analyze and interpret business periodicals, common scientific, professional, and technical journals, governmental regulations, and legal documents
REQUIREMENTS FOR THE POSITION: (EXAMPLE)
- Associate degree or biotechnology certificate preferred, relevant experience in lieu of educational credentials may be considered
- 3-5 years’ experience in pharmaceutical manufacturing
- Willingness to set the bar for safety, compliance, and integrity
- A comprehensive understanding of cGMP compliance
- Proficiency with Windows-based Microsoft Office applications
- Excellent communication skills
- Previous experience with viral vectors or vaccines highly desirable
- Desire to work collaboratively with clients, vendors, and supporting departments
- Must be versatile with strong prioritization skills and possess the ability to delegate tasks appropriately to a wide range of skilled technicians.
- Willingness to perform “hands on” work in a cleanroom environment. Gowning and aseptic processing experience essential.
- Can work around large machinery and typical utilities seen in pharmaceutical facilities
- Must be able to stand for long periods of time
- Able to walk, bend, squat, lift approximately 30 pounds
- Ability to function in a rapidly changing environment & handle multiple priorities.
- A flexible work schedule is required, with the ability to address unplanned facility situations as they arise
- Ability to work with controlled substance and hazardous waste.
- This role is based in Boxborough, MA.
LIMITATIONS AND DISCLAIMER
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position.
All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.
Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently
Vibalogics US, Inc. offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
Vibalogics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.
Vibalogics Germany, GmbH Sie werden von Ihren Kolleginnen und Kollegen sorgfältig eingearbeitet und erhalten ggf. fachspezifische Fortbildungen, um im Anschluss Ihr Arbeitsgebiet eigenständig und sicher verantworten zu können.
Wir bieten eine abwechslungsreiche Tätigkeit in einem modernen Unternehmen mit einer sehr kollegialen Atmosphäre, vielseitige Weiterentwicklungsmöglichkeiten und eine attraktive Vergütung.