- Applies scientific and cGMP manufacturing expertise to address issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines.
- Serves on cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams.
- Identification of single-use process equipment of appropriate scale and quality for the cGMP execution of client specified manufacturing processes.
- Prepares user requirements, obtains vendor quotes, and Capital Requests for equipment.
- Provides technical information for the preparation of change controls, protocols, and new user training for the process equipment.
- Reviews process specifications and provides input for scale up and requirements for GMP manufacturing.
- Reviews batch records prepared based on the process specification.
- Identifies raw materials and consumables of appropriate quality for the cGMP execution of client specified manufacturing processes; assists in the preparation of material specifications, vendor quotes, and the purchase of the materials.
- Responds to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures.
- Uses key and critical process parameters and their associated critical quality attributes in the preparation of product specifications.
- Provides data analysis from each manufacturing run that will be included in intermediate and final project summary reports and other team deliverables.
- 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.
Required Knowledge/Technical Expertise
Individual will have knowledge/expertise relevant to:
- Working within cGMP environments in relation to biologics and vaccine manufacturing.
- Hands on process development or manufacturing experience with clinical scale projects.
- Experience with single-use manufacturing equipment and materials.
- Documented understanding and experience in aseptic techniques.
- Document writing including protocols, batch records, and SOPs and summary reports.
- Experience with Microsoft Excel, Word, and PowerPoint and materials management with SAP.
- Build credibility by performing high quality work.
- Expand the technical capabilities of teams using academic and hands-on experience.
- 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 through meetings, presentations, discussions and documentation with some input from supervisor.
- Minimum supervision required on day-to-day activities and accomplished tasks.
- Ability to work in a team oriented environment is essential, as this person will work closely with other team members and clients.
- 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.
- Master’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with 4 years’ of relevant experience preferably in a cGMP environment; OR
- Bachelor’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with 6 years’ of relevant experience preferably in a cGMP environment; OR
- Associate’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with 8 years’ of relevant experience preferably in a cGMP environment; OR
- High School Degree with 12 years’ of relevant experience preferably 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.