Diego Roman, Ssbb Email & Phone Number

United States

Responsibilities:1) Participate on due diligence initiative for potential network sites by acting as the subject matter expert for technology evaluation and all types of validations.2) Review and approve all development and validation activities.3) Assist in trouble shooting technical issues.4) Provide technical input and evaluation for cGMP Investigations.5) Evaluate and qualify alternate sources of raw materials for CMO products.6) Technical lead for evaluating new product / packaging equipment / technology / systems.

Monroe, North Carolina

Responsibilities: 1) Perform scale up/development work associated with site transfers of drug products. 2) Work with CFT to identify criticalities to transfer and identify development requirements to support.3) Work on process development Activities of multiple projects simultaneously. 4) Write and review technical documents including formulation development protocols and reports, SOPs, specifications, and other necessary technical documents. 5) Work with R&D and Validation on process development to support from scale up to commercial validation. 6) Participate in multidisciplinary project teams through the complete product transfer to support the filing cycle. 7) Organize, and lead technical discussions to support process development and filing timelines. 8) Provide guidance and training to production employees on general and product specific criticalities. 9) Work with Cross-Functional team leads in order to identify opportunities for enhancements and champion projects which will improve overall site function. 10) Work to minimize site costs by finding efficiencies and synergies in the Technology Transfer process.11) Work with development and site multidisciplinary project teams to optimize product transfers for efficient Commercialization. 12) Remain abreast of current regulatory requirements and newest technologies to shorten deliverable timelines and increase the efficiencies of process while maintaining the most current compliance practices.

Columbia, South Carolina

Position Summary:1) Assist the Aseptic Processing Manager in establishing SOP’s as needed. 2) Assist in sampling and weighing of chemicals required to support formulation. 3) Perform validation methods on compounding equipment. 4) Responsible for formulating batch following the batch record. 5) Assist Product Development Engineer in developing of new formulation process. 6) Formulate GMP Development Batches for Validation, Clinical Distribution and FDA Regulatory filings. 7) Follow SOP’s safety, health and cGMP guidelines.

Lancaster, South Carolina

Position Summary:1) Investigate, plan, execute, evaluate and report on new Product Development. 2) Assist in recommendation of equipment for Production and Product Development. 3) Assist in developing new formulations for new active raw materials. 4) Provide hands on technical support and trouble shooting to Solid Dose Operations to resolve process and/or formulation issues. 5) Adjust formulas based on request. 6) Keeping abreast of applicable manufacturing processes, safety procedures, cGMPs and food regulations.7) Perform Laser Particle test on new raw materials on Beckman Coulter LS 13 320.8) Perform tablet coating in LDCS HI-COATER Freund-Vector.

Columbia, South Carolina Area

Position Summary:1) Formulates raw materials into final Sterile Products. 2) Perform and review of new/current Standard Operating Procedures.3) Manage Process Development Studies for new drugs and equipment.4) Manage Process Development Protocols. 5) Edit and propose new Master Batch Record.6) Assist on Validation of new equipments and products. 7) Performs others duties as assigned or apparent.Primary Accountability:1) Gather raw materials in preparation for batch formulation.2) Cleans and inspects raw materials.3) Enters HEPA rooms and performs weighing.Cross Train on Wastewater Chemistry:1) pH testing: range 6.5 - 10.0.2) Test for Chloride: Hach Chloride Drop Test Kit, High Range.3) Submit samples and test result using LIMS program.

4121 Sw 34Th Street Orlando Fl, 32811

Position Summary: 1) Formulates raw materials into Product 2) Assists with additional work duties or responsibilities as evident or required 3) Performs others duties as assigned or apparentPrimary Accountability: 1) Gather raw materials in preparation for batch formulation 2) Cleans and inspects raw materials 3) Enters hepa rooms and performs weighing 4) Completes Documentation of process