The Company – Syner-G Pharma Consulting, LLC
Syner-G Pharma is the world’s leading CMC Consultancy. We are a fast-growing, dynamic, and entrepreneurial consulting firm providing customized science and risk-based approaches for a full spectrum of Chemistry, Manufacturing, and Controls (CMC) needs. We offer a complete suite of CMC solutions (CMC-360) in the following three core areas: Regulatory Affairs, CMC Development & Project Management, and QA/cGMP Compliance.
We work with national and multi-national clients to design and implement science and risk-based, phase-appropriate CMC solutions to expeditiously advance a drug during development and/or sustain the commercial supply chain post-approval. Our CMC-360 business units operate in an integrated fashion to ensure that the solutions we provide fully conform to all scientific standards and regulatory requirements.
At Syner-G, we are distinguished by the high caliber of our team and by our passion for creativity and innovation. We offer scientifically challenging and varied projects, worksite flexibility, and competitive compensation. We pride ourselves on our welcoming and entrepreneurial culture, which is supportive and inclusive of all.
Syner-G Pharma, CMC Consulting is seeking an exceptionally dynamic scientist to join our Analytical Development team. This role will support the drug development programs for our biopharmaceutical clients through the oversight of analytical method development, validation, and transfer efforts. Expertise in laboratory techniques commonly used in the analysis of pharmaceutical products, especially HPLC, is required. The Analytical Chemist will report to the Head of Analytical in our CMC Development & Project Management. A successful candidate will be proficient in experimental design and execution as well as leadership for the analytical development and support of pre-IND stage to commercial manufacturing for a variety of drug candidates including small molecules, peptides, and polymers.
Responsibilities and Experience Required
- Oversee the scientific tasks and activities related to analytical development including support of drug substance synthesis, formulation development, stability studies, method development, method validation, troubleshooting, and method transfer.
- Collaborate with cross-functional project teams to meet the product development milestones and regulatory filing timelines.
- Work closely and effectively with CROs and CMOs to manage outsourced analytical development work.
- Set drug substance and drug product specifications, incorporating an understanding of clinical study design and CMC processes.
- Assign and justify retest/expiry periods, storage, and shipping conditions.
- Understand drug substance and drug product development to independently provide requisite analytical support in a phase-appropriate manner.
- Identify critical in-process-control issues and develop appropriate IPC methods.
- Design stability studies for drug substances and drug products.
- Design validation protocols that are appropriate for validating methods for their intended use.
- Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
- Author or review CMC sections related to analytical methods and method validation, specifications, and stability in IND/NDAs, IMPD/MAAs, and other regulatory submissions.
- Prefer BS/MS/PhD in Chemistry (or relevant discipline) with at least 5 years of relevant experience in ANDA/NDA pharmaceutical product development.
- Additional experience managing cross-functional teams is a plus.
- Excellent presentation and interpersonal communication skills are required.
- Skilled in managing relationships with CROs, CMOs, and testing labs.