Looking for a new job opportunity in a growing, international, and dynamic company?
Enzo Biochem is a pioneer in molecular diagnostics, leading the convergence of clinical laboratories, life sciences, and intellectual property through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards. A global company, Enzo utilizes cross-functional teams to develop and deploy products systems and services that meet the ever-changing and rapidly growing needs of health care both today and into the future. Underpinning Enzos products and technologies is a broad and deep intellectual property portfolio, with patent coverage across a number of key enabling technologies. Enzo has proprietary technologies and expertise in manipulating and modifying genetic material and other biological molecules. Through three wholly-owned subsidiaries (Enzo Therapeutics,Enzo Life Sciences,Enzo Clinical Labs), Enzo targets its technology toward satisfying specific market needs.
About the Role
The Manufacturing Scientist II, Molecular Biology and Genomics will perform a variety of tasks associated with development and improvement of molecular diagnostic products within Manufacturing. This Scientist will aid in the development and growth of the molecular genomics area and will assist in overseeing the daily operations and molecular genomics method validations. This Scientist will accurately document all ideas, concepts and procedures, and assist in writing new procedures following Design Control according to Enzos Quality System that is compliant with 21 CFR Part 820 and ISO 13485 guidelines. The ideal candidate will have strong critical thinking and problem-solving abilities.RESPONSIBILITIES:
- Lead the development, improvement, re-formulation, optimization, and scale-up of assigned molecular products (RUO and IVDs) that meet specifications and customer requirements following Design Control.
- Design and analyze experiments using appropriate statistical methods, document and track results to ensure products will perform consistently.
- Work with other Production Scientists and Manufacturing staff ensuring that all required raw materials, processes and quality tests are accurately documented, and specifications can consistently be met.
- Monitor laboratory operations in order to verify that accurate, precise, and reliable data are being generated for product validations.
- Interact with scientific liaison, project management, administration, and potential sponsors/clients (e.g., Clinical Labs) to gain information and knowledge required to make appropriate business and/or operational recommendations and decisions.
- Responsible for the development and documentation of methods and procedures to manufacture and test new high quality diagnostic products at a competitive cost.
- Routine molecular data analysis, review, and approval of validation reports with aggressive timelines, including writing and revising of Validation plans and SOPs.
- Develop and conduct training on the manufacturing processes within Molecular Genomics.
- Identify problems and opportunities for product improvement reporting them to Manufacturing management for appropriate action
- Trouble-shoot problems using appropriate statistical and analytical tools to determine root cause.
- Responsible for compliance with Enzos Quality System and Federal and State laws.
- Assist in regulatory filing related activities for key IVD, CE, ASR, and EUA products and studies.
Please send your application including your salary expectations directly to Human Resources (firstname.lastname@example.org). If you have any further questions, please do not hesitate to contact us.
- Masters in Molecular Biology, Biochemistry/Biotechnology or other similar areas
- 3+ years of experience in molecular assay design, assay development in a diagnostic environment or a translational research laboratory
- Experience with PCR, qPCR, nucleic acid purification and analysis techniques, primer-probe design, experimental design and data analysis, data interpretation and laboratory automation platforms including liquid handlers
- Excellent general laboratory and organizational skills including the ability to work independently with minimal supervision and to train others in laboratory methods
- Strong communications and PC skills (proficiency in MS Office products, spreadsheet experience and statistical packages) is required.
- Excellent record keeping skills
- Strong team player and excellent interpersonal skills to effectively interact with and influence stakeholders
- Understanding of cGMP compliance and regulatory requirements is a plus