Head of Process Development

Job LocationsUS-TX-College Station Posted Date1 month ago(7/22/2024 8:55 AM)

Requisition ID

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: 2024-27467

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Category

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: Process Development

Company (Portal Searching)

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: FUJIFILM Diosynth Biotechnologies

Overview

The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

As a member of the Site Leadership Team, the Head of Process Development provides strong scientific and administrative leadership to the Process Development and Process Sciences Departments, setting annual goals and objectives and long-range planning. In alignment with the Site Lead and Head of Global PD, the Department Head creates high-level business strategy for the departments, oversees the management of resources and coordinates activities across multiple departments to achieve business objectives and revenue goals. This individual serves as the strategic leader and an advocate for site PD.

The Head of Process Development will lead all PD activities on their site and will contribute towards the global harmonization projects across FDB.

The individual will provide significant scientific and technical contributions and will work closely with the customer to develop strong working relationships. This position supports the process development / process sciences and manufacturing organizations with their associated revenue and profit plans as they relate to the on-time delivery of analytical and process development milestones. This individual has direct impact on overall company performance; impact is achieved primarily by directing the department.

Reports to Site Lead (dotted line to Head of Global PD)

Work Location College Station, TX

Primary Responsibilities:

Individual will have considerable knowledge/expertise relevant to managing and overseeing a team responsible for all PD activities, as well as optimizing and supporting operational excellence and lean activities.

• Responsible for setting annual goals and objectives, and long-range planning.
• Ensures departmental goals and project milestones are achieved.
• Responsible for budget and acquisition of capital equipment.
• Responsible for new business development through the identification and application of technologies, partnerships, or collaborations.
• Responsible for ensuring the development of scalable processes which align with FDBs manufacturing KojoX philosophy.
• Responsible for ensuring the development of robust, phase appropriate, analytical methodologies for efficient transfer and operation in a cGMP environment.
• Supports the sales and marketing activities to attract, secure, and retain client programs.
• Responsible for providing ongoing coaching and feedback and conducting performance reviews for direct reports including setting objectives and development plans, performance management, career development, training, mentoring, guiding, etc. in a matrix man gement structure.
• Reviews and calibrates performance and promotion recommendations for the department to ensure consistency and equity.
• Enhances and maintains a reputation for excellence.
• Resolves conflicts and removes obstacles that stand in the way of accomplishing project goals and objectives.
• Develops procedural requirements and quality standards within the organization.
• Drives innovation programs to maintain and create the opportunity to offer leading edge technologies.
• Fully engages in Client development projects, including working collaboratively with clients to identify technical solutions and escalate risks appropriately; communicates project status and effectively provides technical explanation and rationalization.
• Provides strategy, vision, and direction; makes decisions that establish objectives for the overall direction or operation of a significant project or area.
• All other duties as may be assigned.

Qualifications:

Ph.D. degree preferably in Chemistry, Biology, Life Sciences, or related field, with 12+ years industry relevant experience in process development and/or RandD environment, preferably in the pharmaceutical or biotechnology industry of which at least 5 years of management/supervisory experience OR;

Masters degree in Chemistry, Biology, Life Sciences, or related field with 14+ years years industry relevant experience in process development and/or RandD environment, preferably in the pharmaceutical or biotechnology industry of which at least 8 years of management/supervisory experience.

Matrix management experience preferred.

Previous experience in a Contract Manufacturing Organization (CMO) environment preferred.

Demonstrated ability to direct the activities of a department.

Possesses considerable independence to conduct projects.

Develops procedure and quality standards within the organization.

Demonstrated ability to create new scientific directions of value to the Company, and an understanding of the impact of global trends on development affecting the company and area of own expertise.

Capable of independently conducting projects and able to recommend new areas of research to meet long-term business goals.

Ability to optimize all phases of the experimental design process and effectively leads the planning and execution of projects.

Demonstrated ability to foster a working environment focused on adherence to science, innovation, quality, regulatory standards, and continuous improvement.

Builds credibility within department by performing high quality work.

Expands the technical capabilities of the Process Development / Process Sciences Groups, such as technology development, use of the literature and systems development.

Demonstrated ability to create and nurture an environment that encourages innovation and collaboration around idea generation, experimental techniques, and sharing of knowledge and resources.

Effectively communicates results of own work though scientific meetings, presentations, discussions, and documentation.

Strives for results by setting ambitious tangible results for himself/herself and the team and takes personal responsibility for achieving goals.

Displays the essential ability to work in team-oriented environment, as this person will work closely with other members of Process Development / Process Sciences Groups and participate on multidisciplinary project teams.

Demonstrated experience leading complex projects or programs.

Excellent interpersonal and foll