Senior Consultant, Formulation
- Employer
- Syner-G BioPharma Group
- Location
- Working from Home
- Start date
- Nov 17, 2024
View more categoriesView less categories
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
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.
POSITION OVERVIEW:
The Senior Consultant demonstrates experience and expertise in all aspects of drug development. The Senior Consultant will operate independently, managing day-to-day operations with minimal input or support needed.
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 Drug Product Formulation Projects: Design formulation development studies, troubleshoot formulation issues, support drug product manufacturing activities and provide technical SME advice for all phases of formulation development. Support projects covering small molecule, biologics and encapsulation technology.
- 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.
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 chemistry, biochemistry, chemical engineering, or relevant discipline is required.
Technical Experience:
- 15+ years of relevant experience in pharmaceutical industry.
- Knowledge of drug product development lifecycle for both biologics and small molecule
- Extensive experience with drug product formulation from development through commercial requirements
- In-depth knowledge of lipid nanoparticle formulation techniques (e.g., microfluidics, ethanol injection, solvent evaporation).
- Proficiency in particle characterization techniques (e.g., DLS, TEM, encapsulation efficiency assays).
- Strong understanding of product stability, drug product compatibility, and formulation challenges.
- Familiarity with regulatory requirements and guidelines for drug product formulation, including cGMP and ICH guidelines.
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.
Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
Company
Syner-G Bio Pharma 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, growing the company and geographical footprint across the globe to be an industry leader in integrated biopharma consulting services across the CMC, Regulatory Affairs and Medical Writing verticals supporting small molecule, biologics and medical device development and delivery. Key values of collaboration, a one-team mindset, and benevolence were not only the cornerstone of initial success, but also the culture that has been created since our founding, placing our people at the center of our company.
As an employee, you will experience us leading with our core mission, “To develop and inspire pharmaceutical consulting professionals”. We encourage open, two-way communication throughout the company and provide a supportive and encouraging working environment that allows employees to reach their greatest potential, celebrating those who live our values every day. We realize the vital role a positive work/life balance plays in establishing a rewarding, productive, and long-term career. As a result, a flexible, family-friendly work environment is a key element of our culture and is one of the reasons people want to work (and stay) here!
We offer an outstanding total rewards package, including a competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous unlimited paid time off program, 13 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 locations in Greater Boston, Raleigh, NC, Boulder, CO, and Chennai, India.
CONNECT
- Website
- https://synergbiopharma.com/
- Phone
- 508.460.9700
- Location
-
100 Pennsylvania, Ave, Suite 310
Framingham
MA
01701
US
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