Stephen Minick Email & Phone Number

San Carlos, California, Us

San Diego, Ca, Us

Responsible for clinical production, scale-up, validation, launch, and commercial manufacturing of an extended release non-opioid local anesthetic combination product.Team Lead / Project Management• Headed cross-organization multi-functional 30+ member team responsible for development, validation, and commercial production of Zynrelef®. Responsible for materials and labor yearly budget of $64MM. Approved for distribution by FDA, EMA, and MHRA.• Directed team responsible for 10x manufacturing process scale-up in purpose built cleanroom at CDMO. Output increased from 200k to 2M+ units per year and reduced cost by 80%.• Headed cross-functional team to develop strategy, cost, and timing to transition a commercial drug product’s primary container from vial to prefilled syringe. Oversaw site selection, feasibility, DHF structure / reporting, and manufacturing process development.• Led team to plan product launch in UK and EU. Developed timeline, expense, and risk mitigation strategy to meet requirements for manufacturing, labeling, serialization, regulatory, QA, QC, and staffing. Manufacturing Management• Managed CDMO production of 120 batches of Zynrelef® for commercial launch.• Oversaw qualification and validation of production process / equipment by management of URS, FRS, FAT, SAT, IOQ, PQ, and PPQ package.• Directed aseptic processing validation program including sterile filtration validation, autoclave validation, CIP/SIP validation and media fill process validation. • Developed tools to project inventory draw down for supply chain production planning.• Compiled accurate COGs for end to end production cycle; identified reduction strategies.Regulatory Support• Authored 32P2X and 32P3X manufacturing sections for combination product NDAs. Converted filing for MAA and NDS submissions. Led discussions with regulatory bodies.• Coordination of CDMO 483 observation responses concerning Zynrelef® resulting in follow-up inspection with no 483s.

San Diego, Ca, Us

Responsible for all combination product and drug product manufacturing at Heron Therapeutics. Led team of direct reports to manage NDA submission, approval and commercial launch of syringe based combination product and parenteral injection. Team Lead / Project Management• Responsible for team conducting development, scale-up, validation, and commercial production of Cinvanti®, an injectable anti-nausea emulsion drug product.• Oversaw production of Sustol®, a polymer based seven day extended release injectable anti-nausea combination product, for on-time commercial launch. • Designed and oversaw construction of purpose built pilot lab.Manufacturing Management• Generated RFPs to identify and select potential CDMOs for major new initiatives. Evaluated proposals to determine capability alignment with project needs. Led discussions with key stakeholders to determine recommendation. Presented justification for CDMO recommendation to C-suite team for approval of selection and implementation plan.• Recruited, developed and led CDMO management team supervising four personnel and a $28MM budget.Regulatory Support• Authored CMC sections for combination product and drug product regulatory submissions including NDAs, INDs, and IMPDs.• Acted as Subject Matter Expert for FDA submissions and Pre-Approval Inspections to prepare responses and address FDA queries; interactions resulted in successful drug product and device inspections with no 483s.

San Diego, Ca, Us

Responsible for production, validation, and regulatory support of prefilled syringe combination product during NDA review. Managed tech-transfer of drug product to CMO for production of Phase I and II CTM. Manufacturing / Project Management• Directed validation of Sustol® formulation, fill / finish, and packaging processes at CDMO. Implemented process improvements via appropriate change control procedures and oversaw project documentation to assure cGMP compliance.• Maintained weekly multidisciplinary update meetings between CDMO and sponsor to assure technical, regulatory and quality issues are promptly addressed.• Technical reviewer on commercial supply agreements, MQAs, and development agreements.Process Development• Supervised internal process development team of 5 direct reports including PhD scientists responsible for formulation / process development, equipment specification, and tech transfer.• Managed development of a prefilled syringe consisting of custom designed needle and syringe components including appropriate design control documentation in DHF. • Developed and validated unique process allowing terminal sterilization of prefilled syringes by gamma irradiation.• Assisted Human Factors program to confirm design of prefilled syringe dosing system and components. Authored product preparation section of IFU and revised based on HF feedback.

Us

Increasing responsibilities due to promotions from Specialist to Manager to Senior Manager of Process Development.Liaison between CMOs and sponsor during tech-transfer, process development and Phase I – III clinical production of poly. Managed direct reports to establish internal process development team.• Managed production of Phase I, II, and III clinical trial material through fragmented supply chain of multiple CDMOs.• Participated in Type B meeting and teleconference interactions with FDA to resolve NDA queries. SME at sponsor and CDMOs during FDA inspections to prepare responses and address FDA queries. • Executed RCA investigations and implemented CAPAs, RAs, and FMEAs with a focus on rectification of product contamination, product degradation, and OOS results. • Managed development, implementation, and validation of custom heated components on aseptic syringe filling line. Fill speed increased 15x to commercially viable rate. • Directed development and validation of a comprehensive microbiology testing program.

Us

Responsibilities progressively increased in research and development, prompting promotions from Research Associate I to Research Associate II to Research Associate III.• Responsibilities progressively increased in research and development, process design, equipment selection, and characterization of parenteral products with widely varying target product profiles and administration routes. • Executed pilot-scale production of experimental formulations by creation of batch records, SOPs, equipment specifications, P&IDs, process flow diagrams, and calibration schedules.• Conducted DOE studies to establish design space for developmental and pre-clinical formulations.

St Paul, Mn, Us

• Developed DNA microarrays using a variety of analytical techniques including UV spectroscopy, infrared spectroscopy, and non-contact 3-D imaging.

Bachelor'S Of Science, Biology/Biological Sciences, General

Education record