Consultant I

Synerg; Boston (MA); Ibrido; USD 110.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible paid time off

Office in Greater Boston

Remote work options

Descrizione del lavoro

Syner-G BioPharma Group seeks a Consultant I to support planning and execution of drug substance and drug product development across client engagements. You will be the operational lead for CMC programs, coordinating manufacturing, analytical, quality, regulatory, and supply chain from development to commercialization.

The role involves driving program execution, managing timelines and risks, and supporting clinical supplies management, including forecasting, packaging, labeling, distribution,

Competenze

• Bachelor's degree in Life Sciences or related field required.
• 5+ years of project management experience for Consultant level; 8+ for Senior.
• Experience managing cross-functional CMC programs and external vendors.

Mansioni

• Develop and manage integrated CMC project plans across multiple workstreams.
• Identify dependencies, milestones, and resource needs for execution.
• Coordinate clinical supplies operations including forecasting and distribution.
• Oversee packaging/labeling for investigational products per GMP and regs.
• Develop budgets, forecasts, and manage vendor invoices and changes.
• Lead risk management and governance with clients and vendors.

Conoscenze

Project management

Cross-functional coordination

Regulatory submissions

Clinical supplies management

Vendor management

GMP knowledge

Microsoft Project

Formazione

Bachelor's degree in Life Sciences

Advanced degree preferred

Strumenti

Microsoft Project

Descrizione del lavoro

COMPANY DESCRIPTION:

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace\'s prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Synergbiopharma.com

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.

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.

TOTAL REWARDS PROGRAM

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

LEGAL STATEMENT:

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) 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.