Individual will have considerable knowledge/expertise relevant to managing and overseeing a team responsible for coordinating efforts among Process Development, Manufacturing, and other support groups in the technical transfer of new client processes into upstream and downstream cGMP manufacturing. Knowledge/expertise should be practical and focused on the following activities:
- Manage a diverse team of engineers and technical staff including setting objectives and development plans, performance management, career development, training, mentoring, guiding, etc. in a matrix management structure.
- Oversees the design, planning, and interpretation of process development experiments conducted by the Process Sciences team and applies scientific/technical expertise to address complex issues.
- Leads and manages the Process Sciences team responsible for the identification of appropriate process equipment, defining the execution of the process in manufacturing through batch records and process transfer documents, identification of raw materials and process consumables, preparation of the Process Consumables List, preparation of item specifications for raw materials and process consumables, preparation of the process timeline as intended for execution in manufacturing, and technical leadership on customer project teams.
- Leads and manages Process Sciences team in project work including supporting and coaching team members, participating in sub-teams and contributing to departmental strategies and goals.
- Utilizes expertise to troubleshoot complex problems and develop technical solutions which require the regular use of ingenuity, creativity, and team coordination across functions.
- Mentors co-workers within the function and routinely provides guidance to others on multiple projects.
- Contributes to and ensures the achievement of the Process Sciences team goals and tech transfer milestones on multiple projects without delay in schedule or excessive use of resources.
- Analyzes data from multiple, complex studies to derive decisions on standard, as well as non-standard department deliverables.
- Manages team to ensure quality and timelines of regulatory activities and milestones are met, including the use of technical and scientific knowledge to conduct the appropriate analysis of project documents.
- Provide resources to support technical management of commercial production processes, including troubleshooting, process improvements, and process trend analysis.
- Provide engineering guidance and oversight for system and equipment design, selection, purchasing, receipt, commissioning, specifications, and modifications.
- Provide support to the Sales team on the evaluation of new business proposals and evaluations.
- Evaluate process information to assess whether a process can be executed at FDBT using existing equipment; provide economic justification for capital investments.
- Manages the planning, designing, and executing of multiple projects that are complex and technically demanding within a specific area/field through significant interactions with internal staff, external experts and through critical participation in operations or project teams.
- Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or process improvements.
- Responsible for writing, reviewing, revising, and/or approving Standard Operating Procedures and/or work instructions for cGMP manufacturing of commercial products.
- Perform all other duties as assigned.
Individual will have considerable knowledge/expertise relevant to:
- Knowledge and experience with cGMP concepts.
- Application of statistical concepts and performs higher level analysis involving analytical or process experimental design.
- Troubleshoot and resolve technical issues in technology transfer into cGMP manufacturing.
- Document writing, data interpretation, presentation, statistical analysis and trending.
Required Skills & Abilities:
- Builds credibility within the group by ensuring and reviewing high quality work from Process Science Engineers and Process Science team members.
- Expands the technical capabilities of Process Sciences Group, such as technology development and systems development.
- Mentors and trains others regarding their expertise with respect to the day-to-day goals and activities.
- Effectively communicates results of Process Sciences work though scientific meetings, presentations, discussions and documentation.
- Leadership input focused on status and future of project or technical area and long-term development path.
- Ability to lead and work in team oriented environment is essential, as this position will work closely with other members of Program Management/Process Sciences, the Process Development Group, Manufacturing, and/or participate on multidisciplinary project teams.
- Self-motivated and capable of demonstrating technical competence.
- Excellent interpersonal communication and ability to influence and collaborate with others.
- Analytical and excellent problem-solving skills.
- Comprehensive knowledge of Microsoft Excel, Word, and PowerPoint.
Carries out supervisory responsibilities in accordance with company policies and applicable laws including interviewing, hiring, planning, assigning, directing work, training and development, disciplinary actions, performance reviews, addressing complaints and resolving problems.
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, Engineering, or related field, with 4 years of relevant experience in a cGMP environment, including management/supervisory experience; OR
- Master’s Degree preferably in Chemistry, Biology, Life Sciences, Engineering, or related field, with 6 years’ of relevant experience in a cGMP environment, including management/supervisory experience; OR
- Bachelor’s Degree preferably in Chemistry, Biology, Life Sciences, Engineering, or related field, with 10 years’ of relevant experience in a cGMP environment, including management/supervisory experience.
- Experience in pharmaceutical or biotechnology industry.
- Six Sigma Certification
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.