[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