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:
Syner-G BioPharma is seeking an exceptional candidate to join our team as a Consultant in our Pharmaceutical Development vertical. The candidate will be responsible for supporting our Biotechnology/Pharmaceutical clients across all stages of development, including serving as client lead/project-lead to support the successful development of small molecule active pharmaceutical ingredients (APIs).
WORK LOCATION:
The Senior Consultant, Chemistry position is eligible for remote work based on company requirements, with no minimum in-office requirement.
JOB FUNCTIONS:
- As the Subject Matter Expert for all Drug Substance related items, plan/execute activities collaboratively with the client related to the development and manufacturing of small molecules and active pharmaceutical ingredients (APIs).
- Draft RFPs, identify potential CROs/CMOs, review proposals, and independently manage multiple drug substance CROs and CMOs during various phases of pharmaceutical development.
- Oversee and manage technical drug substance route scoping, manufacturing, starting materials, risk-assessments, process transfer activities, manufacturing process scale-up and CTM manufacturing campaigns.
- Review/approve master and executed batch records.
- Author/review DS related CMC sections for IND/CTA/IMPD/NDA regulatory filings.
- Provide CMC technical due diligence to support business development/in-licensing efforts for clients.
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:
- Extensive experience (>8 years) as a team member in developing/optimizing synthetic processes to support drug development programs.
- Experience with mRNA/oligosaccharides.
- Extensive experience managing relationships with CROs, CMOs, and testing labs to support pharmaceutical drug substance development.
- Proven track record demonstrating productive and collaborative interactions within a multi-disciplinary team driven towards pharmaceutical development.
- Excellent written and verbal communication skills.
Knowledge, Skills, and Abilities:
- Knowledge of wide-ranging process chemistry for small molecule and mRNA/oligosaccharide drug development.
- Comprehensive understanding of the drug substance process, analytical, quality, and regulatory development across all stages of development.
- Ability to solve complex technical issues and the design of experiments for problem solving.
- Ability to effectively prioritize and manage multiple projects and tasks.
- Detail oriented with the ability to anticipate issues and provide mitigation paths forward.
- Strong knowledge of virtual meeting platforms (Teams, Skype, Zoom, i.e.), shared drive services (Sharepoint, Egnyte, Dropbox, i.e.) and Office 365.
- A team player, who listens effectively and invites response and discussion.
- A collaborator who communicates in an open, clear, complete, timely, and consistent manner.
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.
