Christopher Ignace Email & Phone Number

Salt Lake City, Utah, United States

Responsible for strategic input to support nimble, effective, and compliant engineering and product development programs. Support framework for partnerships with drug developers, facilitating data exchange and regulatory submission strategies. Also facilitate identification and handling of regulatory and quality compliance issues through leadership roles.

Mesa, Arizona, United States

Responsible, as internal expert, for introducing US and foreign pharmaceutical companies to Cardinal’s CDMO capabilities regarding FDA filing, technology transfer and manufacturing, as well as supporting radionuclide generator manufacturers with risk management, quality and regulatory compliance needs. Leverages Trade Associations involvement (PET.

Mesa, Arizona, United States

Responsible for optimizing the scientific and medical infrastructure to meet the growing and evolving needs of the company as a result of organic growth and product acquisition, as well as increasing development revenues and decreasing clinical program cost.Highlights:- Created and established staffing levels of Clinical, Medical and Scientific Affairs..

Mesa, Arizona, United States

Responsible for optimizing the regulatory, quality and technical strategies of potential partners. Lead the creation of tools to increase the efficiency of the contracting process as a CDMO, and identify business options that support growth in the theranostic space. Internally, optimize further the technical functions and oversee all FDA regulatory filings.

Mesa, Arizona, United States

Responsible for adapting the regulatory and scientific functions and staffing to the new FDA compliance/CFR regulations. Concurrently lead the CMC development and filing of 3 ANDAs within 18 months. Highlights:- Staffed and formalized Regulatory Affairs, while identifying and remedying talent gaps.- Promoted project and risk management tools, lead.

Provided support related to product and portfolio development and expertise to financial and investment firms.

Melrose Park, Illinois, United States

Responsible for leading the nanotechnology development group (45 employees), supporting scientific and regulatory needs of pre-clinical, clinical and commercial products for US and ROW.Highlights:- Secured termination of one failing developmental program, saving about $300K/year. - Supported key raw material supplier changes (albumin), and further process.

Phoenix, Arizona, United States

Responsible for diverse areas of the business over 9 years through 3 internal positions combined under this section. Initially overseeing site functions, consisting of Production, Engineering, Quality Assurance, Quality Control, Regulatory Affairs, and external CMO performance. Focused on talent management and systems upgrades in support of technology.

Phoenix, Arizona, United States

Phoenix, Arizona, United States

Phoenix, Arizona, United States

• Responsibilities expanded from the science and technology space as Senior Scientist to Product Department team oversight following rapid promotion (<1 yr). Seek acceleration of developmental cycles for generic products.
• Asked to lead multiple aspects of the compliance program at Schein (Watson/Teva) under consent decree; limited the scope of company product recalls and lead a rapid (<3 months) commercial return of InFeD®.
• Developed multiple approvable ANDAs while shortening historical timelines by 30-70%, including resolving within 2 days a 9M old formulation development hurdle for a lead ANDA program.
• Facilitated and promoted a systematic approach to portfolio development with Business Development., resulting in the termination of 20% of financially non-viable programs and the adoption of a formal program selection.

Napa, California, United States

For Dey Laboratory (Mylan/Viatris), responsible for CMC development, which includes establishing novel technique for discriminating solid particle types in multi-suspended systems, and solving filling robustness issues as a result of rheological formulation properties.Highlights:- Resubmitted the CMC of the 505(b)(2) first US generic of Budesonide nasal.

Seattle, Washington, United States

Responsibilities (for ex-ProCyte) expanded from science and technology to Group Leader role following rapid promotion from Senior Scientist (< 1 yr). Responsible for department creation and staffing, for analytical and process development for multiple new drugs and drug products, clinical trial material production, clinical trial compliance, as well as.

Iowa City, Iowa, United States

Responsible for formulation and analytical development programs for multiple sponsors under post-doctoral program. This followed a PhD program about drug design and optimization based on biological feedback (for dry eye treatment), which added skills from prior research from France that included API characterization, cell/tissue isolation, growth and.

Ph.D., Pharmaceutics

Mba, International Management

MBA course work completed. Note: also B.S. Economics from Universite de Rennes, France (1984)

Pharm.D., Pharmacy

Institution: Universite de Haute-Bretagne, Rennes, France (not on drop-down menu, but equivalent to Nimes)