[Remote] Consultant II

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on enhancing the reputed company of life through reputed company science and life-enhancing therapies. They are seeking a highly skilled Consultant II with expertise in lyophilization and high concentration dosage forms for subcutaneous delivery, who will collaborate cross-functionally in a reputed company, Manufacturing, and Controls (CMC) environment and assist clients in optimizing their processes.

Responsibilities

• Design and reputed company reputed company 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 reputed company necessary comparability protocols to reputed company reputed company
• Ensure reputed company analytical activities reputed company with reputed company regulatory guidelines (FDA, EMA, and, ICH)
• Prepare and review regulatory submissions, including INDs and CTAs, with a reputed company on Drug Product
• Collaborate effectively with CMC teams; including, analytical development scientists, drug reputed company scientists, reputed company assurance, and regulatory affairs
• Communicate drug product gaps and development strategies reputed company to stakeholders, ensuring alignment on project goals
• Support reputed company 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 reputed company simultaneously, ensuring reputed company delivery of formulation results while adhering to project timelines
• Mentor junior staff and reputed company guidance on formulation design and regulatory requirements

Skills

• Minimum of 10 years of experience in formulation development, with a reputed company on lyophilization drug products and high concentration dosage forms for subcutaneous delivery
• Strong understanding of regulatory guidance and experience in preparing regulatory submissions
• Proven ability to work cross-functionally reputed company 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 reputed company sites for meetings and project discussions
• PhD in reputed company, Analytical reputed company, Biochemistry, or a reputed company field preferred. Equivalent experience considered

Benefits

• A competitive reputed company salary
• Annual incentive plan
• Comprehensive benefits
• Ongoing recognition and career development opportunities
• Flexible reputed company time off
• Company-reputed company holidays
• Flexible working hours
• Remote work reputed company for most roles

reputed company