POSITION OVERVIEW:

Syner-G BioPharma Group is seeking a Consultant I to support the planning and execution of drug substance and drug product development programs across a diverse portfolio of client engagements. This client-facing consulting role serves as the operational lead for CMC programs, coordinating cross-functional activities across manufacturing, analytical, quality, regulatory, and supply chain functions from early development through commercialization.

The Consultant I is responsible for driving program execution, managing timelines and deliverables, mitigating risks, and ensuring alignment among internal teams, external vendors, and client stakeholders. This role also plays a critical role in clinical supplies management, including forecasting, packaging, labeling, distribution, and inventory planning to ensure successful support of clinical trials.

WORK LOCATION:

Travel to client sites may be required up to 100%, based on project demands and client expectations.

KEY RESPONSIBILITIES: 

(This list is not exhaustive and may be supplemented and changed as necessary.) 

• Develop and manage integrated CMC project plans and timelines across drug substance, drug product, analytical, quality, and regulatory workstreams.
• Identify project dependencies, milestones, critical path activities, and resource requirements to ensure successful program execution.
• Coordinate end-to-end clinical supplies operations, including demand forecasting, manufacturing scheduling, packaging, labeling, release, distribution planning, and inventory management.
• Oversee packaging and labeling activities for investigational products, ensuring compliance with GMP standards, study requirements, and applicable regulatory requirements.
• Develop and monitor project budgets, forecasts, and program financials, including vendor invoice review, scope management, and change order administration.
• Lead project risk management efforts by identifying, tracking, mitigating, and escalating risks and issues that may impact timelines, quality, or deliverables.
• Coordinate cross-functional teams and external partners, including CDMOs, CMOs, laboratories, and specialty service providers.
• Facilitate team meetings, governance reviews, and client status meetings, documenting decisions, action items, and project updates.
• Prepare and communicate project status reports, dashboards, and milestone reviews for clients and internal stakeholders.
• Build and maintain strong client relationships while serving as a trusted project management resource and delivery partner.
• Support business development activities through scope definition, proposal support, and identification of opportunities to expand client engagements.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the education, experience, knowledge, skills, and abilities required.

Education

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
• Advanced degree preferred.

Technical Experience

• Consultant Level: Minimum of 5 years of project management experience supporting pharmaceutical development or CMC programs.
• Senior Consultant Level: Minimum of 8 years of project management experience supporting pharmaceutical development or CMC programs.
• Experience managing cross-functional CMC development programs within biotechnology, pharmaceutical, CDMO, or consulting organizations.
• Demonstrated experience in clinical supplies management, including supply planning, packaging, labeling, inventory management, and clinical trial distribution.
• Experience managing external vendors and development partners, including CDMOs, CMOs, contract laboratories, and logistics providers.
• Proficiency with project management tools and software, including Microsoft Project and related planning and reporting applications.
• Experience supporting regulatory submissions and health authority interactions is preferred.
• Experience working within consulting, fee-for-service, or multi-client environments is preferred.
• Experience with commercial supply chain operations, third-party logistics providers, serialization, and distribution activities is preferred.
• Exposure to multiple therapeutic modalities, including small molecules, biologics, and advanced therapies, is preferred.
• PMP or equivalent project management certification is preferred.

Knowledge, Skills & Abilities

• Strong understanding of pharmaceutical development and CMC activities across drug substance, drug product, analytical, quality, and regulatory functions.
• Knowledge of GMP requirements and clinical packaging and labeling regulations for investigational products.
• Strong project planning, scheduling, budget management, risk management, and organizational skills.
• Ability to manage multiple projects simultaneously while maintaining high quality and client satisfaction.
• Excellent verbal and written communication skills with the ability to effectively engage stakeholders at all organizational levels.
• Strong problem-solving, decision-making, and issue-resolution capabilities.
• Ability to operate independently in a client-facing consulting environment while effectively collaborating with cross-functional teams.
• Demonstrated ability to build trusted relationships and influence outcomes across internal and external stakeholder groups.