JASON L. MCINNIS
Manager, Product Development
Birmingham,AL
Summary
Pharmaceutical professional with 16 years of experience in the development and manufacturing of prescription drug products. Seven years of formulation and process development, Six and half years of manufacturing supervision, one and a half years of QA, and one year of business development experience. Successfully developed two drug products that have been commercialized. Worked with cross functional team to write NDA that was approved in the US, EU, and Japan.
Overview
3
3
years of post-secondary education
16
16
years of professional experience
Work History
Manager, Product Development
BioCryst Pharmaceuticals
Birmingham, AL
05.2017 - 07.2021
- Managed multiple vendors carrying out formulation / process development and manufacturing for clinical trials.
- Designed, executed, and interpreted results for internal experiments.
- Assisted Regulatory in writing various regulatory documents.
- Worked with cross-functional team to write NDS that was approved in US, EU, and JP markets.
- Led product development of drug product that has been approved in US, EU, and Japan.
FORMULATION SCIENTIST
PATHEON PHARMACEUTICALS
CINCINNATI, OH
11.2013 - 05.2017
- Responsible for developing composition and manufacturing process for new drug products ranging from initial characterization of active pharmaceutical ingredients (API) to determine proper dosage form, formulation, and manufacturing process to managing tech transfers of previously developed formulations and manufacturing processes from external sources.
- Direct responsibilities include managing communications to client’s on project status, writing batch records, managing execution of batches, selecting and sourcing raw materials, writing protocols and reports, and managing overall progress of assigned projects.
- Participated in Mini-Transformations (Mini-Ts) to change business processes leading to more efficient use of personnel, equipment, and facility resources.
PRODUCTION SUPERVISOR
CATALENT PHARMA SOLUTIONS
LEXINGTON, KY
10.2011 - 02.2013
- Directly managed up to 65 employees and indirectly managed up to 120 employees.
- Assigned personnel and equipment resources for third shift to execute production schedule.
- Diagnosed production issues and directed inter-departmental resources to facilitate resolution of production issues.
- Performed and delivered monthly and annual performance reviews for direct report employees.
- Monitored batch not right first time (BNRFT) metrics for production batch records and implemented solutions to improve scores for direct report employees.
- Monitored safety, quality, delivery, and cost (SQDC) metrics and implemented solutions to improve scores for my direct report employees.
- Managed implementation of 5S and Lean Manufacturing practices within my department for third shift.
- Participated in inter-departmental Kaizan events and managed implementation of improvements to business and production practices.
- Managed and directed response for safety incidents during third shift.
- Tracked and managed training of direct report employees.
QA SPECIALIST
COLDSTREAM LABORATORIES INC
LEXINGTON, KY
08.2010 - 10.2011
- Review and approve production batch records and validation protocols (pre and post execution).
- Review and approve deviations and CAPAs for manufacturing, validations, and warehouse departments.
- Perform periodic internal audits of manufacturing and warehouse departments to assure compliance with federal, state, and local regulations as well as CLI SOPs and policies.
- Active involvement in inter-department groups to improve SOPs, production batch records, validation protocols, and inter-department cooperation.
- Created and implemented trending metrics for batch record observations.
- Managed warehouse for 3 month period.
- Reduced average batch record observations by 50% in six month time period.
PRODUCTION MANAGER
PHARMAFORM L.L.C
AUSTIN, TX
09.2008 - 06.2010
- Oversight of GMP manufacturing area, including four (4) production rooms.
- Directly supervise fifteen (15) employees.
- Responsible for scheduling of manufacturing projects, personnel resources, room resources, and equipment resources to ensure projects were completed within firm timelines.
- Responsible for writing and updating standard operating procedures.
- Assisted in development of production batch records.
- Reduced number of non-conforming events by 65% in first three months at this position.
- Increased production output per employee by 25% in first six (6) months at this position.
BUSINESS DEVELOPMENT ASSOCIATE
PharmaForm
Austin, TX
03.2007 - 09.2008
- Interacted with over sixty existing clients ranging from virtual companies with two (2) employees to top five pharmaceutical companies with thousands of employees to develop new business and maintain positive relationship.
- Traveled to industry trade shows to market PharmaForm and develop new relationships.
- Created and maintained business development database.
- Became proficient at writing business contracts in three (3) months; exceeding anticipated time to reach this level of six (6) months.
- Increased sales by over $4 million in first nine months at this position - 50% increase.
- Negotiated contracts and closed sales with new and existing clients
- Maintained extensive knowledge of company products and services to provide top-notch expertise to customers
PRODUCTION SUPERVISOR
PharmaForm
Austin, TX
02.2006 - 03.2007
- Oversight of manufacturing processes in two separate production rooms.
- Directly supervised four employees.
- Independently managed second shift for period of six months.
- Production output of second shift with four (4) employees was greater than that of first shift with twelve (12) employees.
FORMULATION SCIENTIST I
PharmaForm
Austin, TX
10.2004 - 02.2006
- Assist in development of pharmaceutical formulations by applying scientific theory to produce formulations and manufacturing processes that meet desired specifications of client.
Education
Bachelor of Science - Cell and Molecular Biology
University of Texas At Austin
Austin, TX 09.2001 - 06.2004
Skills
Batch Record Analysis
Timeline
Manager, Product Development
BioCryst Pharmaceuticals
05.2017 - 07.2021
FORMULATION SCIENTIST
PATHEON PHARMACEUTICALS
11.2013 - 05.2017
PRODUCTION SUPERVISOR
CATALENT PHARMA SOLUTIONS
10.2011 - 02.2013
QA SPECIALIST
COLDSTREAM LABORATORIES INC
08.2010 - 10.2011
PRODUCTION MANAGER
PHARMAFORM L.L.C
09.2008 - 06.2010
BUSINESS DEVELOPMENT ASSOCIATE
PharmaForm
03.2007 - 09.2008
PRODUCTION SUPERVISOR
PharmaForm
02.2006 - 03.2007
FORMULATION SCIENTIST I
PharmaForm
10.2004 - 02.2006
Bachelor of Science - Cell and Molecular Biology
University of Texas At Austin
09.2001 - 06.2004
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