Senior Consultant, Biologics CMC

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. 

WORK LOCATION:

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

JOB FUNCTIONS:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• CMC Strategy and Execution: Develop and implement CMC strategies, timelines, and deliverables for biologic development programs, ensuring alignment with regulatory and business objectives.
• Regulatory Support: Prepare and review CMC documentation for regulatory submissions (IND, IMPD, BLA, MAA), addressing questions from regulatory agencies and ensuring compliance with global regulatory standards. 
• Cross-Functional Collaboration: Collaborate with cross-functional project teams to present and solve critical CMC issues as well as meet product development milestones and regulatory filing timelines. Work closely and effectively with CDMOs to manage outsourced scientific tasks including support of drug substance development and manufacturing, formulation development and drug product manufacturing, analytical method development, method validation, troubleshooting, method transfer, product comparability and investigations.
• Project Management: Manage multiple projects simultaneously, ensuring adherence to timelines, budgets, and quality standards. 
• Risk Management: Identify and mitigate CMC-related risks, developing robust risk management strategies and contingency plans to ensure project success. 
• Budget and Resource Management: Develop and manage CMC budgets, resource planning, and project timelines to ensure efficient use of resources and timely delivery of CMC deliverables. 
• Lead Downstream Purification Development: Design, optimize and scale up downstream purification processes, including chromatography, filtration and other unit operations, to ensure robust and scalable manufacturing of biologics. 

• Technology Transfer: Oversee CDMO/CMO selection and management, maintain client relationships, provide comprehensive CMC services, and conduct a thorough review of technical documents for both early and late-stage clinical production. Oversee and coordinate technology transfer activities to external manufacturing sites, ensuring successful and timely implementation of robust processes. 
• Process Optimization and Troubleshooting: Lead efforts in process characterization, risk assessment, and troubleshooting to ensure consistent product quality and process performance.

• Process Characterization, Validation and Commercialization: Lead process validation activities in all 3 stages of process validation life cycle management. 

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 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.

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.

EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER

Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. 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.