Consultant II

POSITION OVERVIEW:

Syner-G is seeking a highly skilled Consultant II with extensive expertise in lyophilization and high concentration dosage forms for subcutaneous delivery. The ideal candidate will possess a strong understanding of current regulatory guidance and demonstrate the ability to work cross-functionally in a collaborative Chemistry, Manufacturing, and Controls (CMC) environment. Candidate should also have experience working across all phases of clinical development. 

KEY RESPONSIBILITIES:

• Design and develop stable formulations for high concentration subcutaneous dosage forms. 
• Assist clients with the appropriate experiments to optimize lyophilization processes, ensuring product stability and efficacy.
• Manage the transfer of formulation design to trusted CDMO partners and draft all necessary comparability protocols to enable success.
• Ensure all analytical activities comply with current regulatory guidelines (FDA, EMA, and, ICH).
• Prepare and review regulatory submissions, including INDs and CTAs, with a focus on Drug Product. 
• Collaborate effectively with CMC teams; including, analytical development scientists, drug substance scientists, quality assurance, and regulatory affairs.
• Communicate drug product gaps and development strategies clearly to stakeholders, ensuring alignment on project goals.
• Support all phases of clinical development by providing formulation development and design to inform decision-making.
• Participate in project meetings and contribute to the development of clinical trial materials.
• Manage multiple projects simultaneously, ensuring timely delivery of formulation results while adhering to project timelines.
• Mentor junior staff and provide guidance on formulation design and regulatory requirements. 

QUALIFICATIONS AND REQUIREMENTS:

Education:

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered.

Experience:

• Minimum of 10 years of experience in formulation development, with a focus on lyophilization drug products and high concentration dosage forms for sub cutaneous delivery.
• Strong understanding of regulatory guidance and experience in preparing regulatory submissions.
• Proven ability to work cross-functionally within CMC teams.
• Excellent interpersonal and communication skills to facilitate collaboration across departments.
• Ability to work independently with minimal supervision and manage time effectively.
• Willingness to travel occasionally to client sites for meetings and project discussions. 

ESSENTIAL FUNCTIONS:

Physical Demands:
The physical demands described here represent the requirements for successful performance of the essential functions. Reasonable accommodations may be made for individuals with disabilities. While performing job duties, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The role requires frequent walking and sitting, and occasional lifting of objects up to 25 pounds. Vision requirements include close vision and the ability to adjust focus.

Work Environment:
The work environment characteristics include a typical office environment with moderate noise levels, bright lighting, and an indoor temperate setting.

TOTAL REWARDS PROGRAM:
We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture. This includes a competitive base salary, annual incentive plan, comprehensive benefits, and ongoing recognition and career development opportunities. Employees benefit from flexible paid time off, company-paid holidays, flexible working hours, and remote work options for most roles. Office locations are available in Greater Boston; San Diego, CA; Boulder, CO; and India.

Syner-G is unable to sponsor or take over sponsorship of employment visas at this time. 

LEGAL STATEMENT:
 
Syner-G is 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 is an E-Verify employer.