Tim Miley Email & Phone Number

Taizhou, Zhejiang, Cn

Small molecule FFS/FTE CDMO direct business development targeting in North America (East Coast) with peripheral global support into networking and relationship building for peptides and oligonucleotides business (development through commercial), as well.

Providing Supply Chain, Sales, Business Development and Strategy Consulting to global start-ups and virtual clients with a focus on US market entry.

Durham, Nc, Us

Reporting to the Chief Executive Officer, I coordinated intimately with a small, cross-functional team of 12 internal personnel to grow and manage topical product CDMO accounts in every global market except Japan.Secured first development deal (new account) within 75 days of hire, with >45 other ongoing qualified project conversations since mid-2023 (thus, qualified lead pipeline exceeding $25M).Shifted focus toward financially stable commercial pharma targets in an effort to increase commercial manufacturing business with higher revenues and appropriate premium profit margins.

Jingmen, Hubei, Cn

Reporting to the Hubei, China-based General Manager / Executive Vice President for this start-up, I led a small matrix group of 5 personnel, building the entire U.S. (+Europe and India) Marketing, Sales, Advertising, Portfolio and Business Development presence with a $7.5M revenue target for 2023.Generated an organic, conservatively-calculated $17.3M pipeline of 48 projects in 2022/ early 2023 (from the U.S., India, Europe and Pakistan) for KSM and intermediates. A modest marketing expense of <$95K was used, and there was no benefit of FDA inspection history at the time.Introduced Hiray into India, Europe and ROW as of October 2022 (via my global Supply Chain Management network of manufacturing site contacts accumulated during prior career roles). Contracted a very talented direct report technical sales agent in India, from within my network, to assist with KSM, intermediates and API sales into the Indian market.Secured Hiray’s first U.S. customer within 2 months, with projects in discussion with both this customer and others in their upstream network of east coast biotechs. The U.S. entity has continued to remain a valued customer subsequent to my departure.Designed and executed tradeshow exhibit booth manufacture and all hardcopy and e-advertising materials for circulation throughout the U.S. market.Represented Hiray at the company’s first U.S. tradeshows in 2022 – ChemOutsourcing, AAPS, and American Pharma Outsourcing Summit, to solicit advice and feedback on advantageous technologies for 2023 and beyond (photochemistry and electrochemistry, in particular).Quintupled the Hiray LinkedIn pharma/biotech following in Year 1, increasing the company’s follower base in the U.S. by hundreds in the first 12 months.

Bengaluru, Karnataka, In

Reporting to the Chief Scientific Officer in India, I was responsible for designing the entire U.S. business plan, advising LinkedIn marketing/video strategy, planning tradeshow attendance, expanding U.S. brand awareness within the industry (virtual through big pharma), managing the 3 customer accounts on board prior to my joining, and reconfiguring the corporate slide deck to offer more impactful messaging.Contacted an initial set of 163 customer targets (from a target universe of ~1400) via various mechanisms (Biotechgate, LinkedIn, RocketReach) to ascertain near term business potential that aligned with the current technical core competencies.New business development results prior to company layoffs were: (i) verbal interest from four virtual/small biotechs, (ii) one big pharma custom synthesis inquiry, (iii) one pre-IND RFP, (iv) one CTM contract WIP and (v) conversations with a half dozen big pharma targets regarding alternate sourcing API. Amplified downward trend in the company’s global ibuprofen API business, due to global Covid impacts, resulted in broad layoffs, attrition and reconsideration of the U.S. CDMO strategy due to negative corporate results (role/strategy were eliminated).

Fairfield, New Jersey, Us

Reporting to the President, responsible for researching, identifying and selecting new products for manufacture at our partner sites, worldwide. Ultimately, this entailed managing >760 API products and strategically encompassed addition of 40-50 API's per year. Included within this responsibility were IP review, market forecast and analysis, clinical trial monitoring, competitive intelligence and estimation, technical competency review / input from the manufacturing sites, review of SEC filings, major trade show attendance, prospecting, lead qualification, pricing and a host of other business and technical facets used as filters. Managed the custom synthesis/CDMO sales group at SST, targeting KPI’s for revenue and growth quarter to quarter and year-on-year. Project exposure was grown several fold with the capable assistance of a small team that included one technically-trained, M.S.-level direct sales report and one administrative assistant. Business efforts on this front were strategically realigned in 2014 utilizing the expertise of a US-based CDMO in North Carolina, as well as CDMO players based in Asia.Advised the generic API Sales & Marketing team with technical, patent and other talking point data to increase the likelihood of API sales success. This was done via electronic spot promotions, PowerPoint presentations, face-to-face account visits, trade show meetings and/or Zoom/WebEx/Teams/Skype videoconferences.Responsible (as sole contributor) for identifying, qualifying, account development and closing of nanotechnology service offering activities performed by one of our European scientific partners.Technically assisted in identifying and evaluating finished dosage opportunities for our strategic marketing partner, BenAlex. We attempted to marry our existing products, from long-standing relationships with ex-U.S. API suppliers, into opportunistic dosage form market entry in North America.

Starogard Gdański, Pl

While reporting to the Vice President of Global Sales, I crafted and led a portfolio reconfiguration that more closely matched the demands of the North American market, particularly the United States (per Hatch-Waxman and GDUFA), with the kind support of 4 personnel based in Poland (two in Warsaw, two in Starogard-Gdanksi). I managed Polpharma's existing customer base of 85 North American NDA/ANDA accounts, while simultaneously filling the role of U.S. Regulatory agent on 22 active projects.I was responsible for not only sales and marketing of API's into North America ($1.7M in new business), but also tracking the progress of ongoing Phase III clinical trial candidates that served as potentially strong fits for the competencies at the development site in Starogard-Gdanski, Poland.

Hyderabad, Telangana, In

Totally reconfigured the North American new product API offering in Spring 2011, while continuing to prospect, qualify and win new customer accounts and increase sales with the support of three matrix staff based in Hyderabad, India.

Basel, Basel-Stadt, Ch

Both directly and indirectly responsible for leading or supporting > $2 billion in finished product launches during my tenure, while reporting to the Vice President of Business Development & Licensing.Promoted from Manager, Business Development & Licensing; Prior to Eon's merger with Sandoz, I was responsible for FDF in-licensing (dossiers, as well as developmental and clinical stage candidates). Later, I directed significant technical business components of the US-based biologics / biosimilar prospects franchise (505(b)2 and 505(j)), as well as all US API sourcing for all three domestic R&D facilities (Colorado, North Carolina and New Jersey). I was responsible for prospecting, negotiating, facilitating and/or closing strategic 3rd party API development at global CDMO's, authorized generic and dosage form contract development and manufacturing deals. The role spanned all therapeutic dosage forms (solid orals, injectables, patches, films, DPI, MDI, monoclonals, peptides, topicals, and others). My role coordinated with Sandoz personnel and partner centers across 4 continents with Veeva CRM, in addition to external manufacturing sites on 6 different continents with SAP. One PhD direct report assisted in all of these activities within my group.

Shelton, Ct, Us

Contracted by the Senior Vice President of Business Development, I identified privately-owned Analytical Services companies exhibiting at PittCon 2004 for acquisition discussions. Two of the three target recommendations were acquired.

Waltham, Ma, Us

Employee 2 years, Consultant 3 yearsInitially, I was hired into the rapidly growing Analytical R&D staff of this CDMO start-up, then briefly transitioned into a Group Leader role in Analytical R&D (3 direct reports, 3 matrix reports) before transitioning (yet again) into a Business Development support function where I became responsible for crafting the RFP data responses for R&D and QC portions of the broader FDF development and manufacturing proposals being delivered to global target customers.I regularly gave prospective customers facility tours (2-5 times/week) and answered any technical questions or concerns prospective clients might have during our walks around the greater site. I supported the Analytical R&D staff in supervising scientists responsible for chromatographic analyses while simultaneously maintaining a support role for the QC stability group in our ongoing relationship with Pfizer. As the customer base grew, I became the point person for managing the R&D data inputs for all customer finished product regulatory dossiers (primarily NDA/BLA injectables in vial presentations, but there were a handful of solid orals and ointments/creams, as well). This strategically converted AR&D and QC into more of a "profit center" mentality within the overall company, as per the specific request of the VP of R&D. Our corner of the company contributed significantly in both technical support and revenue of the overall site. Some of our key customers were Biogen/IDEC, Genentech, AstraZeneca, Jazz, Merck, Solvay, Roche, Shire, Pfizer, and GlaxoSmithKline, among others. The customer base simply exploded during these early years, driven significantly by the injectables fill / finish capabilities within the legacy facility acquired from GSK (as originally built by Burroughs Wellcome).

Hired by President and majority shareholder, Mr. Fritz Link, I was tasked with evaluating entry into new U.S. business ventures in an effort to diversify the corporate portfolio. Following identification and exploration of the newly developing oligonucleotides industry in the U.S., I led Mr. Link on a U.S. tour of prospective customers within the niche (Ribozymes, Isis, Tanox, among others). Subsequent to detailed customer interviews and NPV analyses, it was concluded that Girindus would spearhead entry into the market by initiating equipment purchases and hiring of scientific talent to its Cincinnati, Ohio facility. The business continues to function to this day, more 20 years later, as part of Nitto Denko Avecia.

Leverkusen, North Rhine-Westphalia, De

I was recruited by Dr. Gerold Mohn (Director, Analytical R&D), at the completion of my doctoral lab work, to relocate to North Carolina to manage a team of 20 scientists through 5 direct reports tasked with providing FDA with process validation data in response to a 1997 Warning Letter. The project was completed on schedule and under budget (one year).

Morgantown, West Virginia, Us

Instructed lab and select lecture sessions, and tutored both undergraduate and graduate students majoring among the five disciplines of medicine, nursing, dentistry, pharmacy and nutrition while completing research obligations necessary for the degree of Ph.D., Biochemistry.

Canonsburg, Pennsylvania, Us

I worked part-time (20-30 hrs/wk) as a Quality Control Analytical Chemist on the evening shift following my daytime classwork and lab research activities in the neighboring WVU medical center as a Ph.D. graduate student (Department of Biochemistry), alongside completing my MBA on the weekends on the downtown campus.

Austin, Tx, Us

Led biochemistry lab sessions for the UT Biochemistry department as necessary for the university's Nursing major curriculum.

Ba, Chemistry

Biochemistry And Molecular Biology (Graduate Level, Non-Degree)

Master Of Business Administration - Mba, Finance, General

Phd, Medical Biochemistry