Senior Consultant, Biologics

COMPANY DESCRIPTION

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. 
 
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations.  

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. 

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second 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 and Sequoia, 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.Sequoiabiotech.com/ or www.Synergbiopharma.com

POSITION OVERVIEW:

We are seeking a highly skilled Scientific Consultant with expertise in the early-stage development of biologics to provide strategic and technical guidance. The consultant will support the selection, characterization, and structural design of biologics candidates, with a particular focus on enhancing developability and manufacturability requirements. This role is ideal for an experienced scientist who can contribute deep expertise in structural biology, protein engineering, and early-stage biologics development to drive successful outcomes in biologics pipelines.

WORK LOCATION:

This position is a remote position, with no minimum in-office requirement. Domestic and international travel may be required for this position (Up to 20%).

JOB FUNCTIONS:

• Provide expert guidance in screening, selection, and optimization of biologic candidates, such as monoclonal antibodies, bispecifics, or fusion proteins, for early-stage development.
• Advise on the design and execution of physicochemical characterization studies, including stability, solubility, and aggregation propensity.Assess developability of biologics based on key biophysical properties to ensure compatibility with subsequent process development and manufacturing.
• Support the structural design of biologics, leveraging knowledge of protein engineering and structural biology techniques (e.g., X-ray crystallography, NMR, cryo-EM) to optimize lead candidates for stability, efficacy, and manufacturability.
• Advise on the preparation and review of CMC documentation, with an emphasis on structural and functional data required for regulatory submissions. Ensure that early-stage development activities align with regulatory guidelines from global health authorities (e.g., FDA, EMA) and industry best practices for biologics. Provide expertise in defining strategies for regulatory filings that ensure the biologic candidates' design and structural data meet CMC requirements.
• Collaborate with internal teams and stakeholders (discovery, process development, analytical development) to align candidate design and characterization activities with overall development goals. Provide mentorship and scientific training to internal team members, facilitating knowledge transfer and technical skill-building in biologics development.
• Engage with external partners, including CROs and academic institutions, to ensure access to cutting-edge technologies and methodologies in early-stage biologics development.
• Act as a thought leader in the biologics development space, providing high-level strategic advice on the selection of lead candidates and the optimization of biologics pipelines.
• Advise clients on technical risks, opportunities, and innovations in biologics discovery and early development, driving decisions that enhance the success of biologic therapeutics.
• Propose solutions to complex scientific challenges that arise during early-stage biologics development, particularly in candidate selection, structural design, and regulatory requirements.

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: 

Technical Experience:

• 15+ years of relevant experience in pharmaceutical industry. 
• Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required. 

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.

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. 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

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; Boulder, CO; and Chennai, India.

Applicants must have current work authorization when accepting a position at Syner-G and Sequoia. Currently, the company is unable to sponsor or take over sponsorship of an employment Visa at this time.

LEGAL STATEMENT
 
Syner-G BioPharma Group and Sequoia Biotech Consulting are 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 BioPharma is an E-Verify employer.