Senior Consultant, Biologics CMC

at  SYNERG BIOPHARMA GROUP LLC

COMPANY OVERVIEW:

Syner-G BioPharma Group is an organization with roots to the Greater Boston area started by industry leaders in 2007 who saw a niche in the pharmaceutical consulting space and leveraged their subject matter expertise and industry knowledge to grow an organization through hard work, trusted relationships, a collaborative approach, and delivering best-in-class client services.
We are helping to enhance human health. Through our expertise, insight, consulting and management skills, we enable clients in their quest to bring life-saving and life-enhancing products to patients. We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery and approval process. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes. 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, Syner-G employees play an instrumental role in maintaining our reputation across the globe as an integrated pharmaceutical science consulting organization.
Syner-G has recently been honored with BioSpace’s prestigious “Best Places to Work” 2024 award. This recognition is 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, 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.

POSITION OVERVIEW:

This Sr Consultant, Biologics CMC (Chemistry, Manufacturing, and Controls) Lead will be responsible for the strategic direction and execution of all biologics CMC activities on behalf of consulting clients. This role will lead cross-functional teams in process development, manufacturing, quality and regulatory to ensure that products are developed and commercialized in compliance with regulatory standards, timelines and business objectives. This role will also be responsible for leading and overseeing the development, optimization, and implementation of biologics downstream purification processes for biologics therapeutics, including antibodies, recombinant proteins, cell therapies, gene therapies, and other complex biologics.

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. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties.

EDUCATION:

• A bachelor’s or advanced degree (e.g., B.S., M.S., Ph.D.) in biology, biochemistry, chemical engineering, or relevant discipline is required.

TECHNICAL EXPERIENCE:

• 15+ years of relevant experience in pharmaceutical industry.
• Knowledge of drug development lifecycle and applied comprehensive understanding of global regulations and guidelines from early to late stage to enhance probability of regulatory success and regulatory compliance.
• Extensive experience in chromatography, ultrafiltration/diafiltration, viral clearance, and other purification technologies.
• Extensive experience with therapeutic protein, vaccine, cell- and gene therapy product development.
• Extensive experience with managing relationships with CRO’s, CMO’s, and testing labs. Proven ability to lead cross-functional teams and effectively communicate complex technical concepts to diverse audiences.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong time management skills: ability to work under pressure in a fast-paced environment, to coordinate multiple tasks concurrently, adapt to changing priorities, and to meet deadlines.
• Excellent project management skills to effectively organize, prioritize, and plan client deliverables.
• Effective relationship-building and client management skills, alongside confidence in decision-making and trust-building.
• Ability to be adaptable, flexible and develop creative approaches to meet customer needs and improve customer outcomes.
• Exceptional stakeholder management skills with the ability to adapt influencing strategies, articulate compelling solutions, uncover client concerns through insightful questioning, and address objections effectively
• Ability to work independently with minimal supervision and problem solve proactively.
• Skilled communicator, both written and verbal, who can present ideas and critical information to clients and internal team members effectively and in a concise, organized, impactful manner.
• Strong organizational skills and attention to detail.
• Demonstrated leadership and management skills.
• Strong critical thinking and problem-solving skills: ability to exercise sound reasoning to analyze issues, make decisions, and overcome problems.
• Ability to work effectively within a team environment by encouraging collaboration and exhibiting an interpersonal style that is enthusiastic, approachable, and supportive.