Program Manager, BBG Advanced Therapies

General Summary

The Program Manager has account project management duties for customer programs requiring cGMP production of cell and cell-based products for clinical application and Cell Therapy Testing services. This role is responsible for supporting BBG Advanced Therapies (BBGAT) sales team members and maintaining current and new client satisfaction during the execution phase of onboarding. Success will rely heavily on the PM's ability to communicate professionally, set, and maintain clear expectations with all stakeholders involved, both internal and external. This position will take direction from BBGAT Principal, Global Market and will function as a primary contact with the customer, for all Cell Therapy Testing Clients and Contract Manufacturing projects as needed through all phases of execution, including Tech transfer, Process and Analytical Development, cGMP manufacturing, QC Testing, and Product Disposition. This position will also help coordinate interactions with the enterprise groups within the organization, including QA, QC, materials management, and Financial Services. This position will work directly with BBGAT staff to manage cGMP projects implementation including coordinating between the customer, internal and external contract performance and organizing the appropriate meetings and communication tools necessary to execute the project. Critical to execution, this position will help create comprehensive schedules, monitor deliverables and payment milestones, contribute to feasibility assessments and prepare product development plans. Utilizing a professional relationship with Clients and knowledge of current and future sales, this role will work with BBGAT sales team members to continuously monitor revenue forecasts.

Commit to and abide by the character of BioBridge Global's Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.

Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

Major Duties and Responsibilities

Essential Tasks
• Become primary point of contact and information for customer projects once contract signature is complete.
• Build and maintain strong working relationships with internal departments working under the direction of the BBGAT Senior Director, Business Development.
• Ensure that project deliverables are met by external and internal team members. Identify and communicate to team those critical areas that have the potential of delaying timelines if milestones not met.
• Ensure accuracy and timeliness of invoicing Clients based upon the unique Terms of contracts is executed at appropriate intervals and milestones. A primary focus will be on Cell Therapy Testing and cGMP Manufacturing as needed, but this responsibility will also include the remaining services for BBGAT as required.
• Identify and communicate to team when scope of work changes have been identified as necessary and are agreed to by the client. Ensure that scope of work changes are appropriately documented in required quality systems and accounted for contractually billing purposes.
• Coordinate the interaction with internal departments in the areas of kick-off calls (Sales), materials procurement and management. Help coordinate tech transfer as well as Process and Analytical Development activities. As necessary, work with BBGAT operations staff to help schedule resource allocation for manufacturing events, QC Testing, and document review (QA).
• In conjunction with BBGAT staff prepare management reports on client satisfaction, success of prior projects in terms of resource allocation, project profitability, and gap analyses for continuous improvement. Communicate to the enterprise leadership regarding any issues that may affect contract performance and execution.
• Will work with BBGAT staff to ensure that internal and external product testing is performed according to contractually agreed specifications.
• Ensure that billing milestones are invoiced in a timely and appropriate way.
• Along with BBGAT Operations staff, help maintain customer forecast accuracy and integrate forecast assumptions with facility and personnel capacity management.
• Coordinate with Operations and Sales / Business Development to identify new project opportunities.
• Provide input on prospective contracts for ability to meet deliverables based on projected resource utilization.
• Maintain current knowledge of regulatory/quality requirements (national and international, i.e. FDA, EU, GHM, ISO, OSHA & cGMP) and perform within all Standard Operating Procedures (SOPs) and policies.

Performs other duties as assigned.

Non-Essential Tasks
• May develop relationships with external customers, researchers, and biotech companies and conduct educational presentations to increase participation with stem cell/clinical research projects.
• Assist other departments as assigned.

Education

Required Minimum Education

Requires a Bachelor's Degree from an accredited college or university.

Preferred Education

Prefer a Master's Degree from an accredited college or university.

Licenses and/or Certifications
• Valid United States Driver's License

Experience

Required Minimum Experience
• Requires five years of program and project management experience, working with internal partners, customers, vendors and / or regulatory agencies to meet deadlines and drive growth of opportunities in a life science setting.
• Requires five or more years of experience in a clinical and/or commercial biologics development or manufacturing setting with hands-on experience in process development and/or cGMP manufacturing for biologics.

Preferred Experience
• Strongly prefer direct experience at a Contract Manufacturing Organization (CMO) that offers GMP and process development services and with direct customer interface experience.
• Prefer experience managing and overseeing subcontractors.
• Prefer experience managing financial goals by forecasting requirements, tracking annual budgets, scheduling expenditures, analyzing variances, reporting revenue recognition, preparing technical progress reports and communicating financial summaries.
• Prefer engineering experience in Chemical, Mechanical or Biomedical fields.

Experience Exception to Education

Knowledge

Knowledge
• Must have an understanding of fundamental project management methods and tools.
• Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

Skills

Skills
• Must have the capability to be a self-motivated and self-managed individual.
• Must have excellent project management skills including scheduling/planning, meeting coordination, tracking of deliverables, reporting to stakeholders and risk mitigation.
• Must be capable of effectively work with individuals at all position levels in the organization to identify, understand and communicate their business requirements.
• Must be capable of operating motor vehicles in all types of weather conditions.
• Must have excellent written and oral communication skills.
• Must have excellent interpersonal and public speaking skills.
• ShapeMust possess the analytical skills and judgment necessary to effectively interpret trends affecting the company.

Abilities

Abilities
• Must be able to keep information confidential.
• Must be able to work in a team environment and relate well to others.
• 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 have extensive experience managing multiple priorities; leading and implementing complex business and contractual issues; and serving as the principal liaison to business executives, internal and external.
• Must have the ability to meet time deadlines, connect and interrelate disparate ideas and thoughts, pay attention to detail, and work effectively with varying constituencies.
• Must work well independently and as a team member as well as facilitate organizational team activities.

Working Environment & Travel Requirements

Working Environment & Travel Requirements

Works in a well-lighted, air conditioned and heated office. May be exposed to electrical and chemical hazards and other conditions common to an office environment. May be required to work at any time of the day, evening or night during the week or weekend to include being on-call. Occupational Exposure Assignment - Category II

Travel Requirements

Ability to use personal motor vehicle for company business required.

Travel up to 50%

Physical Requirements

Physical Requirements

Must be able to drive on behalf of the organization.

Will sit, stand, walk, and bend during working hours.

Requires ability to reach, lift and carry up to 50 lbs.

Requires manual and finger dexterity and eye-hand coordination.

Requires normal or corrected vision and hearing corrected to a normal range.