Supervisor, Formulation Manufacturing

3 weeks ago

Lexington, United States Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**Location/Division Specific Information**:
This position will be site based in Lexington, MA and will support our Viral Vector Services (VVS Lexington) business unit of Thermo Fisher Scientific. At VVS Lexington, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

**Shift**: Night Shift Schedule: 12 Hour Rotating Shift (2/2/3 format) 6:45PM-7:15AM

**Discover Impactful Work**:
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 mínimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

**A Day in the Life**:

- 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.
- Applies 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.

**Keys to Success**:
**Education**:

- Bachelor’s degree preferred (Science, Technology, Engineering, or Math).
- High school diploma or equivalent required.

**Experience**:

- Minimum of 5 years of experience working in pharmaceuticals, or regulated manufacturing environment in lieu of BS degree, or 3 years of experience in pharmaceuticals, or regulated environment with a BS degree.
- 2 years of supervisory experience required.

**Knowledge, Skills, Abilities**:

- 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.
- Able to lift at least 30 lbs and stand for several hours.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelera

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