Director, Center for Innovations & BioDesign
General Summary
The Director for Innovations & BioDesign,will lead front-end customer research to enable the creation of new product and/or service opportunities for BioBridge Global and its business subsidiaries. The role of the Director will be focused on enriching the front-end of the R&D pipeline, with embedded innovation teams, prototyping capabilities, human factors and IP experts. The Director will manage and supervise a team of scientists and technicians to identify customer needs, including those of the patient, hospital, physician, health system, etc. The Director will be responsible for conceiving and inventing prototypes, and deriving solutions. Other roles will include identifying opportunities that are new to the business, but highly aligned with the long-term future of BBG and its subsidiaries. The Director will work with the IP council, New Product Commercialization groups and business units in developing innovation strategies for BBG and its business subsidiaries.
Major Duties and Responsibilities
Essential Tasks
• Responsible for the performance of research projects, whether performed personally or delegated. Manage, supervise and coordinate research, early new product and/or service development, and specialty projects, including any Investigational New Drug (IND) studies.
• Develop the team to build the skills necessary for their function
• Build relationships with clinical sites and outside partners to enable research in the context of the customer's environment
• Define, drive, and improve the Innovation and BioDesign process within BBG
• Deliver new product, service and solution concepts that ultimately enter product development
• Demonstrate strong and clear accountability for the group's performance and delivery.
• Instrumental in data collection, analysis, presentation and scientific publication.
• Actively participate in the process - this is a "get your hands dirty" role where the Director plays a strong role in research and content creation, not just review
• Work with internal and external clients to set Target Product Profile (TPP) and Critical Quality Attributes (CQA) for new products and services.
• Evaluate and/or develop new product and service offerings and make recommendations for improvement to existing business unit offerings.
• Participate in regional, national, and international scientific forums on behalf of BBG and its business subsidiaries.
• Provide guidance and support to team-oriented work projects for the development and implementation of strategic initiatives, which includes development and completion of validations, process improvements, and Standard Operating Procedures (SOPs).
• Participate in strategic planning and execute operational and laboratory tasks related to the commercialization of intellectual property such as Releasate, Premiva, etc.
• Participate in internal and external audits/inspections.
• Display positive leadership skills and champion strategic and management directives with department staff by committing to and embracing the mission, vision, and core values of BBG:
• Be dedicated to the highest standards of quality and adhere to all safety, regulatory, and quality requirements.
• Foster an atmosphere of open, honest communication and knowledge sharing among workers in business units throughout the organization.
• Demonstrate respect for co-workers and management.
• Consistently improve performance outcomes in customer satisfaction, worker engagement (motivation and satisfaction), operational excellence, innovation, and financial performance.
• Maintain a positive work attitude and participate in self-improvement as an effective leader.
• Always maintain a professional demeanor while representing BBG and its business subsidiaries.
Performs other duties as assigned.
Non-Essential Tasks
Education
Required Minimum Education
Requires a Doctoral Degree (e.g., Ph.D., M.D., O.D., or equivalent) from an accredited college or university. The required major is cellular engineering or a related field.
Preferred Education
Licenses and/or Certifications
• Valid United States Driver's License
• US Passport preferred
• Professional certifications preferred
Experience
Required Minimum Experience
• Requires five or more years of experience in cell and gene therapies and product development.
• Requires three or more years of management/leadership experience.
Preferred Experience
• Prefer advanced therapies-related assay development experience.
• Prefer in vivo model product performance testing experience.
Experience Exception to Education
Knowledge
• Must have strong clinical and technical knowledge, and judgement.
• Must have a working knowledge of tissue and cell culture.
• Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.
• Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.
• Must maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current Good Tissue
• Practices), and CLIA regulations.
• Must have a specific understanding of two or more of the following subject matter areas is strongly preferred:
• wound healing biology, bone biology, cell-based therapeutics and/or applied regenerative medicine.
Skills
• Must have excellent hands-on laboratory skills.
• Must have strong time management, public speaking, negotiation, and conflict management skills; strong
• organizational skills essential.
• Must be capable of mentoring team members.
• Must demonstrate positive leadership skills.
• Must be capable of evaluating, interpreting and reporting accurate/valid test results by current testing
• methodologies.
• Must be capable of operating motor vehicles in all types of weather conditions.
• Must have excellent written and oral communication, interpersonal and presentation skills.
• Must have excellent analytical/critical thinking skills.
• Must demonstrate the ability to solve technical and/or clinical problems with biotechnology-based solutions.
Abilities
• Must be a self-starter and self-directed worker.
• Must be able to commit to project delivery timelines and budget.
• Must be able to keep information confidential.
• Must be energetic, enthusiastic and have a team-oriented leadership style.
• Must be neat in appearance and well groomed.
• Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative,
• and have the ability to work independently.
• Must maintain a good working rapport with co-workers.
Working Environment & Travel Requirements
Works in a well-lighted air conditioned and heated laboratory/department. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. May be required to work any time of the day, evening or night during the week or weekend. Occupational Exposure Assignment - Category I
Travel Requirements
Ability to use personal motor vehicle for company business required.
Will work extended hours during peak periods.
Occasional out of town and overnight stays required.
Physical Requirements
Must be able to drive on behalf of the organization.
Will sit, stand, walk, and bend during working hours.
Requires manual and finger dexterity and eye-hand coordination.
Requires to reach, lift and carry up to 20 lbs
Requires normal or corrected vision and hearing corrected to a normal range.
