Consultant II

Syner-G BioPharma Group

Consultant II specializing in lyophilization and high concentration dosage forms for subcutaneous delivery at Syner-G. Managing formulation design, regulatory submissions, and supporting clinical development.

Posted 6/10/2026full-timeRemote • 🇺🇸 United StatesSeniorLeadWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

formulation developmentlyophilizationregulatory submissionsanalytical chemistrydrug product designclinical trial materialscomparability protocolshigh concentration dosage formssubcutaneous deliveryproject management

Soft Skills

interpersonal skillscommunication skillscollaborationindependent worktime managementmentoringguidancecross-functional teamworkstakeholder communicationproblem-solving

Certifications & Qualifications

PhD in ChemistryPhD in Analytical ChemistryPhD in Biochemistry

Industry Keywords

FDAEMAICHCMCINDsCTAsregulatory guidelinesclinical developmentdrug stabilityproject timelines

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

Flexible paid time off
Company-paid holidays
Flexible working hours
Remote work options for most roles
Office locations available in Greater Boston; San Diego, CA; Boulder, CO; and India.