Thermo Fisher Scientific2019s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy Contract Development and Manufacturing Organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
* Address: 250 Binney Street Cambridge, MA
* Day Shift Schedule: 12 Hour Rotating Shift (2/2/3 format) 7PM-7AM
How will you make an impact?
The supervisor in this role will be part of a cohesive team responsible for suite readiness for all phases of manufacturing. The Manufacturing Supervisor uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. The incumbent will also support equipment, documentation, investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
What will you do?
* Lead a team of 3-6 manufacturing technicians.
* Represent manufacturing at tech transfer.
* Team with Engineering to ensure equipment readiness for campaign start.
* Team with facilities and Quality to ensure suite readiness from a change in and compliance standpoint.
* Creation and maintenance of GMP Kanban in support of manufacturing operations.
* Practices and promotes safe work habits and adheres to safety procedures and guidelines.
* Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.
* Manages cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive action Maintain and Improve Systems.
* Supports and develop consistent manufacturing standards for controlled documents used within cGMP manufacturing.
* Conducts complex document revisions and/or document management including batch production records and manufacturing procedures.
* Performs training with staff on the floor, as needed.
* Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology.
* Supports cross-functional company goals.
* Builds cross-functional relationships and enhances relationships with team members.
* Works cooperatively with others to meet group and organizational goals Develops Employees.
* Meet with Supervisors regularly to discuss goals, planning, and progress.
* Continuously builds a high-performance diverse team of people to achieve objectives.
* Develops self and others to improve performance in current role and to prepare for future roles.
* Seeks and welcomes feedback and responds to coaching.
* Provides frequent feedback and coaching to others on ways to improve performance.
* Recognizes and celebrates successes.
How will you get here?
Education:
* HS Diploma/ GED required
* Bachelor2019s degree preferred (Science, Technology, Engineering, or Math)
Preferred Experience/ Skills:
* Minimum of 5 years of experience in pharmaceuticals manufacturing.
* 2 years of supervisory experience highly desired.
* Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).
* Thorough knowledge of cGMPs.
* Strong interpersonal and communications skills (written and oral).
* Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission2014enabling our customers to make the world healthier, cleaner, and safer.
Waltham, MA
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
To serve science, Thermo Fisher Scientific needs to stay ahead of it. To be the world leader in serving science, we need to anticipate (pre-empt) customer needs. We need to constantly think about advancing science, so customers have the freedom to be bolder and more innovative – we are committed to pushing science and technology a step beyond where it is today.