Note: The job is a remote job and is open to candidates in USA. Biologics Consulting Group, Inc. works with medical devices, biologics, and pharmaceutical companies to advance patient health. The Senior Consultant, CMC leads complex CMC scientific and FDA regulatory consulting projects, manages client relationships, contributes to business development, and provides scientific and strategic oversight. The role also includes producing and reviewing client deliverables, mentoring junior staff, and supporting thought leadership and organizational growth.
Responsibilities
- Serve as the CMC subject-matter expert in CMC for technical, quality and regulatory consulting needs
- Serve as the senior project leader or project support, as needed for client delivery of project work
- As senior project leader is accountable for quality and delivery of client work while providing direct consultation to advise them on best approaches that will effectively advance product development efforts including ongoing support from early development through clinical stages and commercialization
- Contribute to the development of high-quality deliverables, including regulatory documents, technical reports, and literature reviews
- Provide quality control for work authored by junior team members and ensure deliverables meet client and regulatory expectations
- Delegate tasks appropriately across junior team members to optimize workflow and promote development of junior staff
- Independently manage client relationships and act as a key point of contact for project execution and issue resolution for projects on which the senior project leader role is held
- Support business development efforts by identifying opportunities within existing accounts and identifying new opportunities, as well as participating in proposal development and review
- Actively participate in mentoring and coaching activities for junior-level team members, sharing expertise in project execution, scientific writing, and regulatory knowledge
- Engage in thought leadership efforts to increase visibility as a subject matter expert in key areas of practice
- The incumbent will lead by example and foster a team environment, ensuring an overall ‘culture of quality’ in the high-quality execution of services provided to clients
Skills
- Alternatively, a master's degree in related disciplines with at least ten years of relevant experience
- Proven ability to lead scientific projects and manage client engagements independently
- Demonstrated success in business development and sales growth, primarily through existing client relationships
- Strong technical writing, analytical, and research skills
- Knowledge of regulatory pathways and strategy development, including familiarity with alternative approaches to regulatory challenges
- Knowledge of Quality Management Systems and auditing for GMP in the manufacturing and QC environments
- Knowledge of EMA regulatory pathways and strategy development, including familiarity with alternative approaches to regulatory challenges
- Effective interpersonal communication and mentoring skills
- Ability to manage competing priorities in a dynamic, deadline-driven environment
- Ability to create effective presentations and leverage current software
- Proficient in Microsoft Office Suite, keyboarding skills, strong documentation skills, math aptitude, diplomacy and leadership skills, professionalism, time management, ability to multitask, able to work independently as well as collaboratively, and able to maintain confidentiality
- Ph.D. in biotechnology, biotechnology engineering, biochemistry or cell and molecular biology from an accredited institution strongly preferred, with at least 5-7 years of relevant industry, consulting, and/or FDA experience
- Prior consulting experience and/or direct FDA or other regulatory interaction strongly preferred
- Previous experience and strong technical subject matter expertise in the process development, validation and biomanufacturing of biologic drug substance and drug product is strongly preferred
- Experience with regulatory expectations for biomanufacturing facilities and equipment is a plus
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