The Associate Director, Technical Project Leader (AD-TPL) leads the TPL group and as part of the Process Development Leadership Team (PD-LT), provides strong scientific and administrative leadership to both the TPL group and the overall Process Development (PD) department. The AD-TPL plays a pivotal role in setting annual goals and objectives and long-range planning for the TPL group. The Associate Director creates high-level business strategy for the department, oversees the management of resources and coordinates activities across multiple departments to achieve business objectives and revenue goals. The AD-TPL also serves as the strategic leader and advocate for the team’s escalations with upper management and external parties.

The ideal candidate for this role will be responsible for the successful technical delivery of gene therapy, vaccine, and advance medicine projects at Fujifilm Biosciences, Texas (FLBT). as well as providing expert technical advice as needed to other functions within FLB sites. The individual will be responsible for supervising a group of TPLs and providing senior technical and scientific leadership to the department as part of the PD Leadership Team.

This position supports the process development and manufacturing organizations with their associated revenue and profit plans as they relate to the on-time delivery of analytical and process development milestones.

Essential Functions:

The individual will have extensive technical and scientific knowledge of vaccine, gene therapy and advance medicines development and manufacturing, gained from practical experience, and will have a high degree of familiarity with GMP manufacturing assets at FLBT. Knowledge/expertise should be practical and focused on the effective technical oversight of projects via:

· Responsible for leadership of the TPL team and ultimate technical accountability for delivery and support of program in the clinical lifecycle.

· Enhances and maintains a reputation of excellence to achieve high levels of client satisfaction through on-time (meeting milestones), on-cost (resourcing via cost model), and right first time delivery of high quality, robust programs.

· Resolves conflicts and removes obstacles that stand in the way of accomplishing project goals and objectives and drives escalation resolution at the Joint Project Team (JPT) level before rising to higher levels.

· Ensure that TPLs work with respective Subject Matter Expert (SME) groups to design experimental plans which maximize the change of success and make the best use of FLB accumulated knowledge.

· Consicely updates the Head of PD of technical problems encountered in the delivery of projects to ensure he/she has the information required for any business critical decisions. Further, works collaboratively with the PD Leadership Team to resolve complex technical issues.

· Defines and implements proceures and practices for the TPL group which will result in increased efficiency and customer satisfaction. Drives efficiency via implementation/use of planning tools and tracks progress with appropriate key performance indicators.

· Builds and nurtures motivated and high achieving project teams and direct reports through excellent leadership (i.e., empathy, servant leadership, accountability) and people management skills. Seeks feedback regularly to self and for team to promote growth and continuous improvement.

· Responsible for providing ongoing coaching and feedback and conducting performance reviews for direct reports. Ensures consistent standards within the TPL teams for the business unit.

· Contribute to the growth of the company ”know how” and increased efficiency in PD program delivery by ensuring effective capture of knowledge arising from the programs under their direction and sharing acros the TPL group and the wider PD community within FLB.

· Keep up to date with the latest scientific developments which are pertinent to FLB and to bing to the attention of the Head of PD & CSO proposals to incorporate the latest technological advances in the biologics field to FLB workflows.

· Responsible for taking a leadership role in the day-to-day operations of projects, able to handle multiple priorities quickly and efficiently including conducting and evaluating training for new or current team members and delagating tasks appropriately.

· All other duties as may be assigned.

Required Skills & Abilities:

· Ability to direct the activities of a functional group within a department.

· Possesses considerable independence to oversee multiple projects.

· Ability to create and nurture an enviroment that encourages brainstorming and collaboration around idea generation, experimental techniques, and sharing of knowledge and resources.

· Extensive experience in the Biotechnology/Pharmaceutical industry with an emphasis on phase-appropriate process development and analytics.

· Capable of full technical leadership and ownership of clinical phase programs and the ability to mentor junior TPLs to be successful technical process owners.

· Establishes and maintains effective relationship with customers and stakeholders.

· Can foster an environment focus on adherence to science, innovation, quality, regulatory standards, and continuous improvement.

· Capable of maintaining close interaction and collaboration with the Program Management function for the succesful delivery of a program.

· Is flexible in dealing with shifting and/or competing priorities.

· Is a good judge of talent and demonstrates ability to attract, lead, and develop team members.

· Supports appropriate employee development opportunities through information, tools, and resources. Provides challenging/stretch assignments to develop and expand staff capabilities.

· Understands the impact of department/function actions on broad organization goals and site finances.

· Consistent and clear about ethical standards, behavior expectations, and consequences.

· Ability to oversee all phases of the clinical program lifecycle and effectively lead the planning and execution of projects.

· Ability to promote high performing, high ”ownership” teams through coaching to resolve at the lowest level of the organization possible, removal of road-blocks and providing support needed.

· Provides expert advice on complex program technical issues and can help resolve problems quickly in a cross-functional (PD, PM, Manufacturing, Operations, Supply Chain, Quality, etc.) and collaborative manner.

· Ability to make ”big picture” linkages. Leverages other projects/initiatives that potentially impact or are impacted by one another

· Ability to collect and analyze lessons of both success and failures across department/functional initiatives.

· Ability to communicate learnings locally and globally as appropriate to share knwoledge.

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.

· Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.

· Ability to lift 50 pounds on occasion and 25 pounds regularly.

· Ability to wear PPE.

· Attendance is mandatory.

Minimum Qualifications:

· PhD Biological sciences or related field and at least 6 years of relevant experience of which at least 5 years of management/supervisory experience; OR

· Master’s Degree Biological sciences or related field and at least 8 years relevant experience of which at least 5 years of management/supervisory experience; OR

· Bachelor’s Degree Biological sciences or related field and at least 10 years relevant experience of which at least 5 years of management/supervisory experience

· Because of the specialized needs of TPL for FDB, knowledge of Fujifilm processes/systems is highly desired and hence, preference or exceptions for Fujifilm Diosynth personnel, especially with previous TPL experience in FDB could be considered.

Preferred Qualifications:

· Experience in pharmaceutical or biotechnology industry with cGMP experience.

· Experience with supervising and handling the administrative and managerial duties of a group of scientists, including performance management and goal setting.

· Significant experience in customer facing roles.

· Experience in managing project timelines and resources to accomplish project milestones.

· Experience in resolving conflicts and removing obstacles.

· Track record of technical development and mentoring of staff.

· Superior oral communcation skills, able to communicate with key stakeholders and global customers.

· Hands-on experience in upstream and/or downstream processing and the analytics related to viral vector production.

· Experience in the operation of lab scale and manufacturing scale equipment used in the purification of viruses, vaccines and biologic.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.