Manager, Manufacturing Technologies
Company: Thermo Fisher Scientific
Posted on: February 13, 2019
Lead the Manufacturing/Technical Team at the High Point, NC site. The group may include, but not limited to, Technical Services/Support, Continuous Process Verification (CPV), Process Validation (PV), Cleaning Validation (CV) and Continuous Improvement. ESSENTIAL DUTIES AND RESPONSIBILITIES
- Providing technical expertise to all manufacturing and control system related issues.
- Managing the technology transfer of products.
- Managing CV, CPV, PV and Technical teams. Create and modify the structure to maintain current and future business.
- Managing and ensuring analytical method and process transfers are completed within the appropriate timelines.
- Liaising with external customers, and external staff ensuring successful transfer of information between both parties.
- Liaising with validation personnel to ensure relevant validation protocols are adhered to including testing requirements.
- Planning, coordinating, and managing the technical transfer team ensuring appropriate target dates and budget targets are adhered to.
- Troubleshooting and advising on analytical methods/transfers as required.
- Daily trouble-shooting, process optimization, technical review of process issues and increased efficiency via continuous improvement measures
- Managing the design and execution of experiments which may serve one or more of the following purposes: method and process development, method validation, cleaning validation, technology transfer, QC, stability etc as required.
- Utilize own expertise and expertise of others to direct the implementation of product/process transfer/development and improvement.
- Preparing and reviewing protocols, reports, SOPs etc and other documentation as required
- Participation in goal-setting and performance reviews for Technical Support team members
- Coaching, direction & supervision of all Technical Support team activities with emphasis on training plans and personnel development
- Planning, co-ordination and leadership of technical transfers for future product introductions
- Active collaboration between technical support team and R&D groups to ensure successful new product introductions and technical transfer activities
- Directing activities of the new product phase-in teams as necessary through the course of the technology transfer phase. Ensuring the new team possesses the skill, knowledge, and abilities necessary to support the pending new product transfer
- Identification, execution, project management and delivery of continuous improvement projects
- Preparation of capital estimates and schedules for future new product introductions
- Project Management of small to medium scale capital projects
- Coaching and training of manufacturing personnel on technical/ engineering elements to increase knowledge sharing
- Ensure adequate & effective cross-site communication of Technical Support activities
- Ongoing support of existing production,
- Generation of batch records and SOP's, technical process investigation and development of training methods for production personnel
- Interfacing with Quality Assurance and Research and Development (R&D) on process requirements for new and current products
- Assisting with on-site transfer projects and product scale-up activities
- Recommending improvements in manufacturing and control systems
- Writing, reviewing, approving of technical protocols; assuring that protocols are approved through proper channels
- Assuring that all test data is gathered and recorded in accordance with cGMP requirements
- Analyzing data to ascertain if it meets related protocol acceptance criteria; writing deviation reports as required upon failures to meet protocol acceptance criteria
- Writing reports and assures that they are approved through proper channels
- Providing support in investigations and other troubleshooting activities
- Adhering to all GMP and safety requirements, SOP's and Company policies and procedures
The candidate must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
Ph.D. in Science or related field with 2-4 years of experience, Master's Degree in Science or related field and 2-4-6 years of experience or BS in Science or related field and 6-8 years of experience which must include specific experience in a pharmaceutical industry, or equivalent combination of education and experience.
Department: Manufacturing & Production - provided by Dice Development, Manager, Management, Project, Project Management, Protocol, Protocols, Quality Assurance, Research, Supervision, Technology Transfer, Testing, Validation
Keywords: Thermo Fisher Scientific, Greensboro , Manager, Manufacturing Technologies, Executive , Greensboro, North Carolina
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