[Hiring] Consultant I @Syner-G

Role Description

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

• 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

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

Requirements

• Minimum of 5 years of project management experience supporting pharmaceutical development or CMC programs (Consultant Level).
• Minimum of 8 years of project management experience supporting pharmaceutical development or CMC programs (Senior Consultant Level).
• 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.

Benefits

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Ongoing recognition and career development opportunities.
• Generous flexible paid time off program.
• Company-paid holidays.
• Flexible working hours and fully remote work options for most positions.
• Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India for those who prefer a physical work location.

Legal Statement

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.