Process Sciences- Associate Scientist/Engineer
The Process Sciences - Associate Scientist/Engineer, under general direction, functions within a team based organization to actively address cGMP manufacturing issues. The individual is responsible for analyzing process technologies to assist in the technical transfer of new processes into the manufacturing group. This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.
- Applies scientific, technical and industry knowledge to address issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines.
- Lead a least one cross-functional technology transfer team that will include client technical staff and internal process development and manufacturing teams.
- Prepares user requirements, vendor quotes, and purchasing of equipment.
- Provides technical information for the preparation of change controls, protocols, and new user training for the process equipment.
- 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.
- Writes intermediate and final manufacturing campaign summary reports and other team deliverables.
- Perform all other duties as assigned.
Required Knowledge/Technical Expertise
Individual will have knowledge/expertise relevant to:
- Experience in the manufacturing environment for biologics and vaccine manufacturing.
- Hands on laboratory or manufacturing experience with biologics projects.
- Knowledge of single-use manufacturing equipment and materials.
- Understanding and experience in aseptic techniques.
- Document writing including protocols, batch records, and SOPs and summary reports.
- Experience with Microsoft Excel, Word, and PowerPoint.
- Build credibility by performing high quality work.
- Expand the technical capabilities of teams using academic and hands-on experience.
- Effectively communicates results of own work through meetings, presentations, discussions and documentation with some input from supervisor.
- Limited 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.
- Ability to lift up to 20 pounds regularly and up to 50 pounds on occasion.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to wear personal protective equipment to include safety glasses, lab coat, gloves or other equipment as required.
- Attendance is mandatory.
- Master's Degree; OR
- Bachelor's Degree at least 1 years of relevant experience; OR
- Associate's Degree with 4 years of relevant experience.
- Degree preferably in Engineering, Chemistry, Biology, Life Sciences or related field.
- Work experience in a cGMP environment.
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 979-431-3500.