The Company – Syner-G Pharma Consulting, LLC:
- A young, dynamic, entrepreneurial and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
- Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Distinguish ourselves by our passion for creativity and innovation
- Offer flexible work environment allows for on-site, off-site and virtual-office scenarios
- Clients include national and multinational pharmaceutical companies
- An aspiring science professional driven by learning and applying scientific principles to solve CMC technical and project management challenges
- Has a passion to help patients by enabling the expeditious development and approval of high-quality, life-saving medicines
- Has a MS or Ph.D. in biochemistry, chemistry, molecular biology, chemical or bio engineering fields with at least 10 years experience in the Drug Substance/Drug product area of gene therapy or biologics within the biotech/pharma industry
- Familiar with FDA, ICH and other relevant CMC/Quality and cGMP guidance documents
- An “outside the box thinker” who is not limited by dogmas but have a passion for applying current scientific and technical principles to design innovative strategies and solve technical CMC challenges
- Should be diligent in paying attention to details and take pride in delivering high quality output within defined timelines
- Should be fluent in MS Office (Word/Excel/PowerPoint/Project) suite of products and familiar with CMC documentation as well as experienced in the use of Gantt charts
- A great team player with leadership qualities to work with cross-functional teams
- Has excellent written and verbal communication skills
- Proficient in drug substance production techniques(especially in the biologic space), processing, and characterization of drug substances and drug product and have CMO management experience.
- Ability to work with diverse stakeholders, both internally and at commercial contract manufacturers.
- Strong knowledge and demonstrated practice of cGMP.
- Detail-oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
- Ability to troubleshoot problems, work within a team, and independently design, develop, and execute experiments.
- Ability to manage a number of projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.
Critical success factors:
- Knowledge and experience in pharmaceutical development(biologics and gene therapy), manufacturing and testing (combination of drug substance, drug product development or analytical/quality control)
- Likes working in entrepreneurial settings and takes responsibility and ownership for the deliverables
- Independent thinker and self-motivated
- Enjoys learning and applying problem solving skills in a fast-paced setting
- A sense of urgency and appreciation for the expedited development of life-saving medicines
- Strong appreciation for science-based CMC development
- Comfortable with multitasking and making decision and progress under ambiguous scenarios
- Comfortable and confident in presenting ideas to large audiences and in smaller client settings.
Job Category: Director
Job Type: Full Time