- Applies scientific and technical expertise to address the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines.
- Serves as the technology transfer lead to manage the requirements of a cross-functional team.
- Responsible for the design of a process characterization and validation program including the preparation of protocols and summary reports.
- Identification of Single-use process equipment of appropriate scale and quality for the GMP execution of client specified manufacturing processes.
- Assist in the preparation of user requirements, vendor quotes, and purchasing of equipment.
- Assist in the preparation of change controls, protocols, and new user training for the process equipment.
- Define the execution of the process for GMP manufacturing through process specification documents.
- Identify raw materials and consumables of appropriate quality for the GMP execution of customer specified manufacturing processes; assist in the preparation of material specifications, vendor quotes, and the purchase of the materials.
- Communicate plans to the customer for the characterization, validation and GMP execution of manufacturing processes; answer client and/or internal staff questions or concerns about complex technical problems and develop technical solutions for those issues.
- Guide the internal project team and the customer to establish key and critical process parameters and their associated critical quality attributes using this information to assist in the preparation of product specifications.
- Analyze data from each manufacturing run and/or other complex studies to derive decisions on standard as well as non-standard department and team deliverables.
- Provide support to the Sales Team in the evaluation of new business proposals and evaluations.
- Lead team projects by supporting and coaching team members and participating in sub-teams contributing to the strategies and goals of each project.
- Perform all other duties as assigned.
Required Knowledge/Technical Expertise
Individual will have considerable knowledge/expertise relevant to:
- cGMP concepts in relation to biologics and vaccine manufacturing.
- Process characterization and validation
- Application of statistical concepts and demonstrated ability to perform higher level analysis involving analytical or process experimental design.
- Troubleshooting and resolving technical issues in technology transfer into cGMP manufacturing.
- Document writing, data interpretation, presentation, statistical analysis and trending.
- Process engineering and process scale-up/scale-down design.
- Good skills in aseptic technique are essential.
- Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint.
- Build credibility by performing high quality work.
- Expand the technical capabilities of the teams in process development, engineering and validation.
- Train other members of the team with respect to the day-to-day goals and activities by imparting their expertise to the group.
- Effectively communicates results of own work though meetings, presentations, discussions and documentation with some input from supervisor.
- Minimum supervision required on day-to-day activities and accomplished tasks.
- The ability to work in team oriented environment is essential, as this person will work closely with other team members and participate on multidisciplinary project teams.
- Self-motivated and capable of demonstrating technical competence.
- Excellent interpersonal communication skills and ability to influence and collaborate in a team environment.
- Analytical and excellent problem-solving skills.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, along with some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Ability to lift up to 20 pounds regularly and up to 50 pounds on occasion.Attendance is mandatory.
- Ph.D. preferably in Chemistry, Biology, Life Sciences or related field, with 4 years of relevant experience in a cGMP environment; OR
- Master’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with 8 years’ of relevant experience in a cGMP environment; OR
- Bachelor’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with 10 years’ of relevant experience in a cGMP environment.
- Experience in pharmaceutical or biotechnology industry.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.