Maloney John
Senior Vice President at Exela Pharma Sciences
- Role
- Vice President at Xyz-Xla
- Location
- Salisbury, NC, US
- LinkedIn followers
- 500 followers
About Maloney John
I am looking to network in pharmaceuticals and business development. CEOs, COOs, SVPs, Board Members, Recruiters, HR Managers, Hiring Managers.connect with me to get access to my network deep in industry Consistently successful in pharmaceutical, animal health, cosmetic and other chemical product development, production and commercialization, from concept and design through manufacturing. Ensured compliance with rigorous regulatory standards. Promoted product safety and effectiveness. Skilled in: Product Commercialization / Analytical Research / Process Design / Quality / Research Design / ICH & FDA Compliance / Technology Transfer / NDA / cGMP / QA / HPLC / ANDA / CMC / FMECA Led fast track production launch. Harmony Labs / Ei client had lost their prior source of 42 different pharma and OTC product formulations, and had only a six-month supply on hand. Led high priority program to launch production. Completed all formulas within 180 days, generating millions in new revenue and wining new contracts. Multiple OTC / DESI drugs were on the market without validated analytical methods. Assumed control of analytical validation group. Revamped writing, executing and review. Completed 62 HPLC / GC validations and restored compliance for Harmony Labs / Ei clients. Expanded drug R&D for new market entry. Harmony Labs began as a cosmetics manufacturer. Company R&D existed primarily to secure manufacturing business in its established market. Turned the unit into a profit center by expanding R&D into drug development, a lucrative new market that ultimately generated millions in new revenue. Ensured compliance of product to specification. Pipeline of Taro’s best-selling product was frozen for being out of specification (OOS) on an impurity. Modified and revalidated method that had inaccurately generated a high OOS result. Made possible release of $7M in completely compliant product.
Experience
Vice President
Mar 2013 — Present · Charlotte, NC, US
Responsible for product development of sterile Injectable and ophthalmic drug products. Provide leadership to the development team and execute the strategic product development plan.
Education
Buffalo State University
Ph.D., Chemistry
The College of Saint Rose
BA, Chemistry
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.