Job Title: Supervisor, Research & Development
Requisition ID: 140760BR
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
- Greenville, NC
- Drug Product - North America
How will you make an impact?
In this supervisory role you will be supervising 3-4 employees. This role will support In-Process testing for Sterile and continuous manufacturing, providing laboratory testing support to meet the business objectives of the business. This is a client facing role, engaging and supporting clients.
What will you do?
- Manage staff responsibilities for the day-to-day operations.
- Review departures from procedures and recommend action for approval by Manager. Approve GMP records.
- Monitor the performance of staff such that corporate and business goals are met.
- Meet throughput goals for batch dispositions, assessment, investigations, and validation projects.
- Recruit and develop staff. Train staff. Apply progressive discipline programs as required.
- Develop and implement policies and procedures. Implement approved changes in collaboration with labs, production, regulatory, client and Quality. Ensure that work is appropriately documented per GMP. Make decisions regarding acceptability of results and documentation. Identify issues requiring review by management.
- Establish actions and implement systems to achieve process improvements and efficiencies to address shortcomings in processes and systems.
- Serve as principle in problem solving, failure analysis and quality or process system design activities related to product quality. Evaluate protocols, procedures, documents and results for scientific and/or business merit. Ensure areas of responsibility are compliant with industry standards and trends.
- Draft submission ready sections of regulatory dossiers for drug products for approval by management. Draft specification rationales for drug products.
- Draft standard operating procedures. Write appropriate reports and correspondence. As needed, write reports for clients.
- Maintain knowledge of public standards, regulatory trends and cGMPs.
- Serve as the technical and regulatory expert. Back up to key regulatory inspection contact. Participate in negotiations with clients, regulatory reviewers and inspectors on issues to assure timely resolution of issues or approval of client applications.
- Comply with all job-related safety and other training requirements.
- Perform other duties as assigned.
How will you get there?
- BS Degree or BA degree in Chemistry, Biology or life science discipline. Chemistry background preferred
- 4+ yeas equivalent work experience
- 2+ years supervisory experience
- Project management
- Process testing, method transfer and validation
Knowledge, Skills, Abilities:
- Knowledge of methods development approaches, analytical validations, quality control statistics, documentation and adherence to SOPs preferable in solid oral dosage form.
- Ability to write quality technical reports and give effective oral presentations.
- Excellent oral and written communication skills.
- Ability to effectively collaborate with others to achieve team goals and expectations.
- A genuine interest in researching and implementation of new approaches to analysis.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
To Apply, please click the following link: https://thermofisher.contacthr.com/82408789
Apply on company website