Manager Of Chemistry

Description:

Create a culture of scientific exchange emphasizing research in acute and chronic pancreatitis, pancreatic cancer, gastrointestinal imaging, and genetic testing. Donate time, energy, and resources to encourage research through our pancreatic grant program. • Experience in reviewing batch records for manufacturing and/or have worked on a manufacturing line before • Understanding how a product is filled and finished • Lead and manage regulatory CMC activities to support developing strategies for appropriate filings. • Oversee technology transfer to commercial manufacturing site(s) • Provide input to process development teams for developing GMP manufacturing processes • As part of the manufacturing team, develop strategies for clinical, commercial supply for future trials and product launch. Provide timely regulatory and documentation review. • Prepare, review, and/or edit cGMP batch records, CMC regulatory and quality documents. • Ensure regulatory authority submissions are complete and compliant with applicable requirements. • Write and review technical documentation and recommend changes as appropriate to ensure regulatory compliance and conformance with existing regulatory filings and requirements. • Research and analyze regulatory information and maintain current regulatory knowledge. • Oversee implementation of manufacturing process development and improvements • Identify and mitigate risks in manufacturing operations • Investigate production variances and deviates to identify root causes and document corrective and preventive actions. • Coordinate all activities for commercial drug products including release and stability testing • Perform CMO oversight including routine audits, technology transfer, and implementation of a compliant environmental monitoring, water, and raw material testing program • Participate in routine FDA inspections and provide written responses to 483 observations • Write and revise SOP documents to ensure cGMP compliance including conducting monthly SOP meetings with staff members • Perform OOS investigations including writing/approving deviation reports and corrective/preventive actions • Execute assay qualification and validation including writing protocols and final reports • Interact with contract testing labs, including coordination of sample submission, review, and approval of test results • Perform routine analysis of commercial drug products, API, reference standards, and raw materials using HPLC and wet chemistry techniques • Will need to travel a couple of times a year to their manufacturing sites for a few days at a time

Skills:

Analytical chemistry, Method Development, hplc, manufacturing, batch record review, empower, FDA, Stability testing, Sterile filling, Injectables, Aseptic

Top Skills Details:

Analytical chemistry,Method Development,hplc,manufacturing,batch record review,empower

Additional Skills & Qualifications:

• Minimum of Bachelor's Degree in chemical, physical, or biological science • Minimum 3 years experience in a laboratory setting • Prior experience in an analytical technique • Waters HPLC experience required • cGMP experience required • Excellent attention to detail • Proficiency with Microsoft Word, Excel, Outlook, and Empower • Proven organizational and problem-solving skills • Must be able to formulate and clearly communicate ideas, both verbally and in writing • Ability to work both independently with little guidance, and within a collaborative group environment

Experience Level:

Expert Level