Consultant I - CMC Program Management

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.

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.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements 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 use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.