- Responsible for taking a leadership role in the day-to-day operations of process development and customer projects. This positon will also be responsible for conducting and evaluating training for new or current team members.
- Develop and embed efficiencies and industry best practices, on PD projects, with internal and external customers.
- Establish and manage a Technical Project Leadership function within the PD group.
- Enact change management to ensure groups within PD are efficiently and effectively delivering customer programs from clinical to commercial phase.
- Own and manage the PD resourcing, and milestone processes, working with PD leadership, to ensure the effective delivery of PD operations.
- Own and manage the PD tier system, ensuring integration with the site wide tier system.
- Responsible for developing and managing the EHS, Quality and lab management operations within PD.
- Create and nurture an environment that encourages collaboration around idea generation, experimental techniques, and sharing of knowledge and resources.
- Integrate efforts across teams and resolve problems to ensure effective delivery of PD and customer programs.
- Lead interdisciplinary teams on complex projects; contribute significantly to the leadership and coordination of the process development group.
- Mentoring of staff.
- Work alongside development leadership in the planning and coordination of major projects.
- Heavily involved in setting the direction of the company’s process development efforts, having a significant impact on the future of the company.
- Drive the adoption of best practices across the PD departments (DS, US, AD, AMT, and Process Sciences).
- Adhere to all relevant compliance requirements.
- Continuous improvement of existing systems as well as implementation of new process development systems, including training of employees to ensure FDBT maintains best practices in the industry.
- All other duties as required.
Individual will have extensive knowledge and expertise relevant to process development, program and change management, and ways of working within FDB.
- Strong knowledge and understanding of all process development fields; Upstream, Downstream, Analytical, AMT, and Process Sciences.
- Expertise in the delivery of customer programs within FDB.
- Expertise in program and change management.
- Deep knowledge and understanding of delivery of development projects with uncertain timelines.
- Extensive knowledge and awareness of cGMP and large scale manufacturing.
- Experience and expertise in the development and manufacture of complex biomolecules.
- Experience of leading teams working on complex projects.
- Proven customer management skills in a fast paced environment.
- Extensive experience in managing resources, time lines and milestones to ensure the timely delivery of complex, multifaceted projects.
- Comprehensive knowledge of Microsoft Office, including Word, Excel, PowerPoint and other analytical applications.
Required Skills & Abilities:
The Director will possess the following skills and abilities:
- Proven and strong leadership skills.
- Able to work on broad and highly complex problems, both technical and non-technical, developing sophisticated and elegant solutions, which may span company boundaries.
- Able to recognize and leverage innovative opportunities.
- Proven ability to develop the capabilities of other staff members for the preparation and presentation of complex scientific information to internal and external groups.
- Role will involve frequent and extensive direct interaction with internal and external groups; therefore, excellent written and oral communication skills are required as well as excellent interpersonal skills.
- Demonstrated ability to manage multiple priorities while being flexible and responsive to shifting priorities.
- Excellent organization and analytical skills.
- Able to develop clear procedures for program documentation, customer communications, reports to executive leadership, etc.
- Able to provide leadership in a team oriented environment is essential, as this person will work closely with cross functional groups and lead multidisciplinary project teams.
- Excellent time management skills with the ability to multi-task and self-manage activities.
- Demonstrated effective resource and program planning/decision making.
- Excellent problem solving and conflict resolution skills and the ability to identify, assess, and resolve problems, issues, risks, and facilitate issue resolution and risk mitigation.
- Active ownership of problems of a diverse technical and business scope where the analysis requires in-depth evaluation and research of competing options.
- Identify, recommend and implement opportunities for streamlining team and business processes to reduce costs and improve efficiencies.
- Partner with stakeholders to ensure effective and timely completion of deliverables and to ensure the team achieves and maintains a high level of sustainable performance.
This is a leadership role which includes providing ongoing coaching and feedback, input into performance management and ensuring that the goals of the PD group are met. The holder assumes a managerial leadership role by setting standards, timeframes and priorities, interacting with other departments and assisting with the administrative and managerial duties for Process Development.
- Provide input regarding acquisition of capital equipment.
- Achieves results within defined budget, timing and resource parameters; considers the impact of resource allocation on other work streams.
- Demonstrates ability to lead and develop indirect subordinates to grow within the organization.
- Supports appropriate employee development opportunities through information, tools and resources.
- Promotes systems and processes that encourage the development of people at all levels of the organization.
- Places emphasis on open, honest and tactful communication.
- Understands the impact of department/function actions on broad organizational goals.
- Sets clear performance standards and holds staff accountable for achieving business results.
- Leverages other projects/initiatives that potentially impact or are impacted by one another.
- Collects and analyzes lessons of both successes and failures across department/functional initiatives.
- Communicates learnings so that they can be broadly translated into ongoing activities/responsibilities.
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, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Hand-eye coordination and manual dexterity sufficient to operate office and laboratory equipment.
- Ability to wear personal protective equipment (PPE).
- Lift up to 25 pounds frequently and up to 50 pounds occasionally.
- Attendance is mandatory.
Minimum Qualifications (In addition to the above requirements):
- D. in a science related field and 4 years relevant experience; OR
- Master’s Degree in a science related field and 8 years of relevant experience; OR
- Bachelor’s Degree in a science related field and 10 years or relevant experience.
- Experience in a cGMP facility.
- Supervisory/Management experience.
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.