- Applies scientific and technical expertise to address complex issues in 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 including the client technical staff and internal process development and manufacturing teams.
- Identification of 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 unit operation plans and batch records.
- Provide identification of raw materials and consumables of appropriate quality for the GMP execution of client specified manufacturing processes; assist in the preparation of material specifications, vendor quotes, and the purchase of the materials.
- Communicate plans to the client for the GMP equipment, materials and procedures; 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 client 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 and manage all team projects by supporting and coaching team members and participating in sub-teams contributing to strategies and goals.
- Troubleshoot complex problems and develop technical solutions which require the regular use of ingenuity, creativity, and team coordination across functions.
- Mentor co-workers within the function and routinely provide guidance to others on multiple projects.
- Contributes to and ensures the achievement of goals and tech transfer milestones on multiple projects without delay in schedule or excessive use of resources.
- Perform all other duties as assigned.
Individual will have considerable knowledge/expertise relevant to:
- cGMP concepts in relation to biologics and vaccine manufacturing.
- 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.
- Solid knowledge and experience in process engineering and process scale-up/scale-down design.
- Good skills in aseptic technique are essential.
- Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint.
Required Skills & Abilities:
- Build credibility by performing high quality work.
- Expands the technical capabilities of teams using technology development, literature and systems development.
- Trains 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.
- 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 6 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.