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 is seeking an experienced Senior Consultant to serve as a strategic Chemistry, Manufacturing, and Controls (CMC) leader supporting pharmaceutical and biotechnology clients through all phases of drug development. This individual will act as a trusted advisor, providing technical leadership, strategic guidance, and hands-on execution across CMC development programs for biologics, and cell and gene therapy products.
The ideal candidate will possess extensive experience in drug substance and drug product development, regulatory strategy, technical operations, and CMC program leadership. This role requires exceptional communication skills, the ability to influence cross-functional teams and external partners, and a proven track record of successfully advancing development programs from early-stage development through commercialization.
The successful candidate will operate independently while partnering closely with clients, Contract Development and Manufacturing Organizations (CDMOs/CMOs), regulatory agencies, and internal teams to ensure successful program execution and delivery of high-quality outcomes.
JOB FUNCTIONS
(This list is not exhaustive and may be supplemented and changed as necessary.)
- Serve as a trusted CMC advisor to clients, providing strategic guidance across all phases of product development.
- Lead and manage CMC development activities for drug substances and drug products, ensuring alignment with program objectives and regulatory requirements.
- Oversee CDMO/CMO selection, qualification, contracting, and ongoing management to support development and manufacturing activities.
- Develop and maintain strong client relationships while serving as the primary technical point of contact for assigned programs.
- Provide technical leadership and strategic oversight for analytical development, process development, technology transfer, manufacturing, and product characterization activities.
- Review, author, and provide final approval of CMC-related regulatory documents and submissions supporting clinical trials and commercial programs globally.
- Collaborate with cross-functional teams, including Regulatory Affairs, Quality, Nonclinical, Clinical, Manufacturing, and Supply Chain stakeholders.
- Identify program risks, develop mitigation strategies, and proactively resolve technical and operational challenges.
- Facilitate decision-making processes and provide recommendations based on scientific, technical, regulatory, and business considerations.
- Support project planning, execution, timeline management, and milestone tracking to ensure successful program delivery.
- Participate in business development activities, proposal development, client presentations, and marketing initiatives.
- Mentor junior consultants and contribute to the continued growth of Syner-G's technical capabilities and consulting excellence.
QUALIFICATIONS AND REQUIREMENTS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required.
Education
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, Life Sciences, or a related scientific discipline required.
- Advanced degree (M.S., Ph.D., Pharm.D., or equivalent) preferred.
Technical Experience
- 15+ years of experience within the Pharmaceutical, Biopharmaceutical, Biotechnology, Cell and Gene Therapy industries.
- Extensive expertise across the full CMC lifecycle, including development of drug substances and drug products.
- Demonstrated experience leading CMC strategy, technical operations, and regulatory support activities.
- Experience managing CDMO/CMO relationships and external development and manufacturing partners.
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.
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