Development Specialist Research
Resume:
HEATHER V. LANDIN CV – ****
Email: ********@*******-*******.***
Baldwin, WI 54002
REFERENCES ON REQUEST, SEE MY LINKEDIN PROFILE FOR ON LINE REFERENCES. WWW.LINKEDIN.COM/IN/HEATHERVLANDIN
Application Development Specialist, CCRA 2017-Sept. 2020
Preco Inc., Hudson, WI -
●Biochemical Engineering, Microfluidic devices, Biochips, Wound Treatments, using lasers, micro coating, and placement
●Chemical and materials in process and QC test development.
●Filed IP on unique approach to containing tissue growth stimulators with bioabsorbable materials.
●Chemical safety review, ISO 9001, ISO 13485 Quality Management projects, SQL systems database setup, fluent in Microsoft Access front ends.
Quality Engineer 2016-2017
Loparex, Hammond, WI -
●Statistical analysis for specification development and engineering support, test development, specification and customer quality/GMP contract coordination and negotiation, GMP and ISO Auditing, risk review for GMP process compliance.
●Developed SQL/Access SPC overview report packages for management use using QDMS, PRISM, and PARADOX databases.
Product Development Specialist, CCRA 2007-2015
3M, Personal Care Division, St. Paul, MN -
●Research specialist and Investigator for daily use safety studies as a required premarket qualification for use of microneedles for over the counter facial use. Obtained a Development Grant to fund team for these studies, organized a 15% time effort expert clinical research team and managed/monitored 4 clinical studies, coordinated with Singapore research team to develop and file IP on an over the counter applicator based on study results that improved safe use.
●Led cross divisional effort for Medical GMP manufacturing to identify alternative clients for the Singapore manufacturing plant to fund new market launch scaleup.
●3 patents filed on organosilicone nano-reinforced polymer compositions, RF wetness sensor, and organosilicone skin adhesive.
●Responsible for identifying corp. resources, capitol investment requirements, and developed NTI project plans based on division strategic timelines and cost targets. Led expert team that proved feasibility of manufacturing green elastomeric nonwovens by reactive extrusion.
●Product engineering role for EBL loop product in Fairmont MN and San Louis Potosi, Mexico plants. Materials processing expert. Responsible for product/process redesign, standards development, and product manufacturing qualification and validation activities and teams using failure mode analysis and statistical process control methodologies resulting in 25% increase in line capacity.
Sr. Clinical Research Associate (CCRA) 2004-2007
3M Medical Division, St. Paul, MN -
●Responsible for Clinical Research and global claims maintenance support for Surgical Drape Teams and Surgical Prep Teams. Worked closely with regulatory. Researched and wrote CE mark submission for Ioban Drapes. Supported US and International Submissions and regulatory maintenance and update requirements for INDs and 510Ks.
● Managed and monitored multiple clinical studies supporting claims and commercialization of new generation DuraPrep, Ioban Drapes, Cardiac Electrodes, skin sanitizers.
●Worked closely with marketing to define health economic studies to support ideation for new business development of patient warming devices and hand sanitizers. Scoped manufacturing feasibility and costs working with outside suppliers.
Advanced Clinical Research Associate 2000-2003
3M Pharmaceuticals and Drug Delivery Systems (DDSD), St. Paul, MN -
●Developed protocols and carried out research involving animal, microbiological, and preclinical research.
●Clinical Research Phase II/III for Infectious Disease and Actinic Keratosis. Site management. Initiated and monitored clinical study sites in 15 contract clinics in US and Canada. Contracted and closed clinics, negotiated international contracts.
●Responsible for identifying and developing solutions for inherent material incompatibility issue affecting dose delivery for DDSD Metered Dose Inhalers using designed experiments and SPC and SQC methodology. Solutions included transfer of new to the world polymer technology to develop a next generation seal technology. Responsible for validation studies and reports to customers on integrating customers’ molecules into Metered Dose Inhaler formulas.
Technical Marketing / Business Development 1997-2000
3M, Performance Materials Division, St. Paul, MN -
●New Market Initiative: Technical member of customer survey team, researched and identified OEM value chain, analyzed technology fit with customer wants and needs in the Polymer and Fluids Additive market for 30+ 3M technology platforms.
●Worked closely with sales team and international subsidiaries coordinating distributors and developing detailed construction bid packages for large contractors such as Fluor Daniels and Bechtel. New business for 3M
●Responsible for global scale up of 14 Light Water products with UL, EU, and local certification requirements. Supported Nuclear Regulatory listings and optimized the products for Korea business opportunity.
●Contributing member of API Fire Protection Committee, contributed to API refinery protection standards.
Product/Process Development Specialist 1990 -1997
3M, Commercial Fire Protection Business, St. Paul, MN -
●Led teams for materials development, systems design, process development, and commercialization of fiber, polymer, ceramic, and insulative engineered systems that performed to UL, ASTM, NRC, and ISO Fire Test standards.
●Worked with suppliers and our business team to develop UL and ISO regulated manufacturing strategy for rubber compounds, ceramic intumescent materials, graphite intumescent compounds, devices, and non-woven processes. (Cottage Grove, Decatur, Bristol, Alexandria) using SPC and SQC.
●Obtained 3M grant to develop fire protection systems for industrial and offshore petrochemical markets working with the 3M Light Water sales force arrangement.
●Coordinated with QC and manufacturing to implement UL and ISO manufacturing criteria for certified component production. Wrote all process control and QC test standards for commercialization of new products in both elastomer compounding and wet laid felt making processes.
●Participated in ASTM business related subgroups and chaired industry curtain wall subgroup of AAMA. Wrote test standards and industry best practices for a curtain wall fire safety publication for these organizations.
Product Development / QA Engineer 1986 - 1990
3M Microbiology Dept. / Petrifilm, St. Paul, MN -
●Reformulated Petrifilm microbial growth media and worked with suppliers to tightly control raw material quality resulting in improving performance to meet statistical equivalence and efficacy standards required by the food and water testing markets.
●Worked with business team and outside manufacturers to develop new microbiological testing kit manufacturing and shipping strategies for culture media and temperature sensitive test products including Elisa, PCR, etc.
●Co-led GMP process development and scale-up of Petrifilm in Brookings. Wrote all Petrifilm GMP process and QC test standards based on statistical process and statistical quality control.
COMMERCIAL PRODUCTS DEVELOPED
Dyneon Fuel Line Hose
Scotchgard UV Wood Protector (Coatings)
Dynamar Plastic Processing Additive (original polymeric product)
Petrifilm second generation SM Microbial Test Plates
3M Fire Protection Plastic Pipe Device
3M Fire Protection Intumescent Wrap Strip compound
3M Fire Barrier Bond and Seal Adhesive
3M Fire Barrier I10C-Mat
3M Fire Barrier G-Mat
3M Fire Protection Ceramic Fiber Intumescent and Endothermic Mats
3M MDI combinations to OEM market
3M Duraprep next generation
3M EBL-V Stretched Corrugated Fiber Loop for Hook Fasteners
PATENTS
US 4,567,237 Ethylenically unsaturated polyesters (1986)
US 4,654,233 Radiation-curable thermoplastic coating (1987)
US 5,765,332 Fire barrier protected dynamic joint (1998)
US 5,830,319 Fire Barrier Flexible Felt Composition (1998)
US 5,974,750 Fire barrier protected dynamic joint (1999)
US 6,153,674 Fire Barrier Material (2000)
N018336 Wetness Sensor – global filing (2008)
N047912 Film Forming Gel for Minor Wound Treatment – global filing (2014)
N050224 Method for Solvent-Assisted and Solvent-Free Preparation of Surface Modified Nanosilica Filled Silicone Thermoplastic Elastomer (SPOx) Formulations and Their Potential Use in Adhesive and Bonding Applications
AWARDS
Certificate of Appreciation 1987 from the Microbiology group for outstanding performance reformulating the AC Petrifilm growth medium.
3M corporate Global Process Development Award (#1 team world wide in 1989 for ‘Outstanding Quality Improvement and Cost Reduction on the Petrifilm Process’
3M Medical-Surgical Division Quality Program Achievement Award 1989
3M Ceramic Material Division Team Quality Award for FS-195+ fire stopping compound 1992
3M Construction Markets Division new Product introduction award 1995
3M division Level Circle of Technical Excellence Award 1998
3M Alpha Grant of $60,000 to develop facilities protection marketing package for the petroleum industry. 1998
3M Personal Care Division Spirit Award for EBL-V Line upgrade, 2014
PUBLICATIONS
Grant Proposal (Univ. of Minn.): The Chemistry of Lillium Self Incompatibility (1981)
Fluorocarbon Elastomer Processing Aid - Effects and Mechanism in LLDPE, LLDPE Conference, Zurich (1985)
Fire Prevention in High Rise Buildings - Booklet (AAMA tir document 1995)
Significant Contribution to API Standard for Fire Safety in Refineries (1998-99)
Rationalizing Fire Protection Budgets; investment VS Loss dollars – Industrial Fire World, Houston (2000)
Literature Review of Ioban efficacy and impact of incision Drapes on Infection Rate – EU CE Medical Device Submission
PAST MEMBERSHIPS AND INVOLVEMENT
ASTM E.06.21 Joint Systems Subcommittee - Chair of Hose Steam Subcommittee
American Architectural Manufacturers Association (AAMA) - Chair of the Committee on High-rise Fire Safety
Minnesota Chapter of the Product Development Association
National Fire Protection Association
American Petroleum Institute – Supplier Member and standards contributor
3M central IRB
ACRP Association of Clinical Research Professionals through 2018. Certified CRP 2003-2018
EDUCATION AND CERTIFICATION
BS Chemistry Macalister College
BA Biology Macalister College
3 yr. of Graduate Course Work in Biochemistry,
Genetics, Statistical Genetics, Computer Science University of Minnesota
Mini MBA St. Thomas University, St. Paul, MN
Technology Management Certificate (1/2 completed) Cal Tech, Pasadena
Certified Clinical Research Associate (CCRA) Ass. of Clinical Res. Professionals (ACRP)
GMP certified (not up to date) 3M hosted instruction
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