Avid Bioservices Inc (CDMO)

[biopharm]

Michael Molony looks to be next in line to replace Masten. For being with Peregrine for only 8 months... lots of accomplishments lined up already

Gilead looks like they went after one of Avids employees.... for losing out on Michael Molony to Avid.

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April Loui
Director, CMC Clinical Quality at Gilead Sciences

Director, CMC Clinical Quality
Gilead Sciences
November 2014 – Present (6 months)

Director, Quality
Avid Bioservices
October 2011 – October 2014 (3 years 1 month)
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https://www.linkedin.com/in/awloui

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Michael Molony
Director at Avid Bioservices

Summary

BIOTECHNOLOGY SCIENTIST & DIRECTOR
Results-driven, goal-oriented Biotechnology Scientist and Manager with over 25 years of broad-based management experience in contemporary laboratory operations, advanced analytical and experimental procedures, and the effective support of successful biotechnology development efforts. Strong working knowledge of modern analytical methodologies, automation systems, and statistical experimental design techniques. Exceptional ability to concurrently manage complex, multi-step laboratory experiments while meeting rigorous procedural standards, tight time-frames, and design/write/execute operational protocols. Over 10 years of GMP laboratory experience with a proven track record of successful regulatory inspections.

Technical Experience Key Words:

HPLC, microsequencing, amino acid analysis, Gel Imaging, Electroblotting, Binding Kinetic studies, peptide synthesis, carbohydrate analysis, MALDI-TOF, ESI-MS, ELISAs, Robotic Liquid handling, capillary electrophoresis, residual process impurities, cloning, blotting, sequencing, restriction mapping, BSL-3 room, automated cycle sequencing.

Certifications: PMP, Agilent Chem Station Plus CDS Administrator, LabWare LIMS system Administrator I & II, JMP, SIMPCA-P (Multivariate Analysis), Stat-Ease DOE Software, FOSS NIR Software, Waters Empower CDS Administrator I & II.

Memberships: CaSSS, ACS, PDA, ASQ
Experience
Avid Bioservices
Director
Avid Bioservices
July 2013 – Present (1 year 10 months)Orange County, California Area

Responsible for identification and transition of new products and technologies into the Quality Control laboratories to increase capability and capacity. Overhaul raw materials processes and improve in house raw material testing capability. Lead Avid QC method transfer and validation efforts for high profile client for Phase III/Commercial lauch.

Managed daily QC operations for a contract manufacturing service. Responsibilities included process improvement to streamline the department with the concepts of lean manufacturing and six sigma processes. Oversight of greater than 4 clients release and stability testing services. Oversee QC service offerings to include client method development, validation and expanded in-house raw materials testing. Actively looked for and engaged potential new clients with Business Development group to grow business. Modernized the QC laboratories with equipment upgrades as well as transitioning lab toward a paperless laboratory.

•Led team of 15 for raw materials, lot release and stability testing for several high profile clients
•Team member involved in providing input into ‘Request for Information’ and ‘Request for Proposal’ for prospective clients.
•Sponsored six sigma, lean manufacturing and continuous improvement efforts to streamline daily operations in QC
•Participated in Peregrine Pharmaceuticals CMC team as a consultant/individual contributor for lead Phase III candidate
•Overhauled QC Stability program: SOP Improvement; OOS and OOT procedures to include relevant statistical analysis criteria and outlier detection, Stability SOP to reflect current ICH guidelines, increase internal capability by expanding 'submission ready' stability reports for clients as well as increase storage solutions meeting all four world climactic zones for liquid dose formulations
Gilead Sciences
Associate Director of Analytical Development & Quality Control
Gilead Sciences
March 2012 – June 2013 (1 year 4 months)Oceanside, CA

Oversite of Gileads Biologics Analytical Development and Quality Control. Part of a team for Gilead biologics development, manufacturing and quality centered out of Oceanside, California, that produces Pre-clinical to Phase II clinical material supplies. Team identifies Phase III and commercial supply CMO and performs technology transfer to CMOs. Responsiblity in all regulatory filings in the areas of characterization as well as DS and DP release and stability.

• CMC Responsibilities

• Analytical Development CMC team representative for phase III new biologic entity (Simtuzumab)
•Oversight of AD CMC representative on two early stage products
•Review of all biologics regulatory filings
•Management Responsibilities: Head the Analytical Development and Quality Control departments to support all Gilead development and quality control activities for all Gilead Biologic molecules.
•Successfully led QC team through state board inspection for site licensure.
•Ensured personnel were properly trained and operating in a compliant manner in GMP laboratories.
•Ensured that internal and contract testing laboratories are in compliance with Gilead SOPs and standards.
•Participated in technical assessments of CMOs and participate as an SME in quality audits as requested and later managed Analytical Method Technology Transfer to CMOs.
•Responsible for drug substance release of early phase clinical trial material manufactured in the Oceanside facility.
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https://www.linkedin.com/pub/michael-molony/5/7a8/bb5

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