Principal/Senior Scientist / Associate Scientific Fellow - Process Res

DR. MARK D. SCHWINDEN

**** ********* **.

Wilmington, MA 01887

Mobile: 215-***-****

***************@*****.***

KEYWORDS Organic chemistry, PhD, process, development, PAT, pharmaceutical, API, manufacturing, design, optimization, route scouting, CRO, GMP, analytical method development, asymmetric, isotope, custom synthesis, research, synthesis, chemist, purification, documentation.

PROFESSIONAL Unicon Pharma / Agios Pharmaceuticals, Cambridge, MA 02139

EXPERIENCE - Principal Scientist / Contractor, CMC Process Chemistry (July 2022 – Present)

- Contractor through Unicon Pharma (South Plainfield, NJ) performing process R&D and final

form research at Agios Pharmaceuticals (Cambridge, MA), a pharma company focusing on

treatment of genetic blood disorders.

- By synthetic route scouting, demonstrated new chemistry that increased the yield of the final step

of synthesis of a pre-clinical candidate by 250%. Successfully transferred chemistry to CDMOs.

- Use of PAT (e.g, ReactIR, DSC) to determine reaction kinetics, mechanisms, and energetics.

- Learned use of PAT to help find the most stable crystal form of preclinical candidates and salt forms (PXRD, Crystal 16, EasyMax, PLM, DSC, TGA).

- Maintain frequent communications with CDMOs to transfer and implement analytical methods, synthetic research results, and final form research results.

ThirdLaw Molecular LLC, Blue Bell, PA 19422

- Senior Scientist, Chemistry (Mar 2020 – July 2022)

- Startup company funded by the DoD to perform COVID-19 research. Prof. Schafmeister of

Temple University - Founder/CSO/President

- Research into the synthesis of spiroligomers, for both incorporation into lateral flow assay devices

for the rapid detection of viruses in in vivo samples and other applications.

- Assisted in equipping a new laboratory. Assisted in the purchase of ~$2,000,000 worth of

instruments and labware. Trusted to appropriate company funds wisely.

- Advisor to very junior members of company (recent PhDs) regarding safe lab practices and proper

maintenance of lab.

J-Star Research, Cranbury, NJ 08512

- Principal Scientist (Sept 2018 – Mar 2020)

- Expert in refining processes for scaleup. Multi-kilogram production of API and

Intermediates in up to 200-L reactors. Expert in research of alternative chemistries more

amenable to scaleup.

- Lead scientist for research, development, characterization, and production of active

pharmaceutical ingredients and intermediates in a CRO. Final form research.

- Management of project timelines and thorough communication with clients. Writing / reviewing

technical documentation & data.

Bimax, Inc., Glen Rock, PA 17327

-Research and Development Chemist/Project Leader (June 2017 – Sept 2018)

- Research and Development Chemist, leading efforts to improve synthesis and scalability of

specialty monomer production, from multi-gram to multi-kilogram scale. Focused on all aspects of project leadership, including technical/safety concerns/issues, budgeting, timeline management. Focused on customer satisfaction. Empower chromatography software experience. StageGate project management tools.

Cambridge Isotope Laboratories, Andover, MA

- Principal Chemist/Group Leader: QC Method Development / Separations / Research

Products (Jan. 2006 – June 2017)

- Supervisor/Group Leader to five BS/MS/PhD chemists performing syntheses of a wide variety

of isotopically-labeled targets to customer standard and cGMP production requirements. Responsibilities include work supervision and evaluation, performance development.

- In Research Products, responsible for inventing, carrying out complex, non-routine GMP and

non-GMP synthetic chemistry. Includes kilogram-scale production of API, raw materials, and

many batches of glucose from starch. Preparation/proofreading of Master Batch records.

Participation in OOS investigations. Preparation of CAPA reports.

- In the Separations Group, chromatographic separations of isotopically-labeled natural and

unnatural synthetic and biologic products, including sugars, amino acids, surfactants, various raw

materials. Includes ion-exchange chromatography and normal/reverse-phase chromatography.

- In QC Method Development, responsible for development and transfer of analytical methods including HPLC (UV, RI, and ELSD), GC and LC/MS for use by both Quality Control and Research Products for release testing of products. Impurity isolation and identification. Chiral and achiral chromatography, reverse phase and normal phase chromatography. Troubleshooting instrumentation and method problems. Resource management, review and approval of laboratory data. Some stability testing.

SCYNEXIS, Inc., Research Triangle Park, NC 27709-2878

- Research Scientist/Project Leader, Chemical Development (Sept. 2003 – Jan. 2006)

- Responsible for the research, development, and production of active pharmaceutical ingredients and intermediates in a contract research organization. Includes optimization of existing

syntheses and investigation into new syntheses.

- Responsible for preparation of quotes for clients and prospective clients. Writing/reviewing

technical documentation & data. Preparation and execution of Master Batch Records. Required

management of project timelines and thorough communication with clients. Includes preparation

of GMP material.

Bristol-Myers Squibb PRI, Lawrenceville, NJ; Chem. Process R&D (May 1992 - Aug. 2003)

- Research Investigator I (May 1992-Oct. 1994)

- Research Investigator II (Oct. 1994-Oct. 1997)

- Senior Research Investigator I (Oct. 1997- Aug. 2003)

- Responsible for the research and the development of several active pharmaceutical ingredients

and intermediates. Includes invention of new synthesis and optimization of existing syntheses.

Preparation of GLP and GMP drug substance. API final form research and production.

- Experience as the Process R&D representative to Development Coordination Team. Experience

as Final Form Team member. Exposure to Project Working Group functions – encompassed early

development through marketing, including clinical. Assisted in preparation/proofreading of CMC

regulatory documentation prior to IND filings. Skilled in writing/reviewing technical

documentation & data. Preparation and execution of Master Batch Records.

Postdoctoral position at University of Virginia; Prof. Robert E. Ireland supervisor (Oct.

1990 - April 1992) Research toward the total synthesis of polyether antibiotics. Asymmetric

synthesis using carbohydrates.

AWARDS Customer Service Award, Cambridge Isotope Laboratories, September 2010

Successful R&D effort to scout new routes to produce 13C-labeled dextromethorphan under cGMP.

EDUCATION Ph.D., Synthetic Organic Chemistry; Iowa State University, Ames, Iowa;

& TRAINING Advisor: Prof. G.A. Kraus

Dissertation title: “The Norrish Type II Reaction in Organic Synthesis,” Diss. Abstr. Int. B1991,

51 (11), 5324-5. Development of new synthetic methodologies and the total synthesis of natural

products by thermal and photochemical alkoxy radical generation and cyclization.

B.S. Chemistry with Honors; North Dakota State University, Fargo, North Dakota.

Safety Training, 24 Hour HAZWOPER Site Worker (OSHA 29 CFR1910.120(e)). Completion Date March 28, 2018.

Adult First Aid/CPR/AED. American Red Cross, Completed Jan. 2023.

PATENTS W.W. Wood, M.D. Schwinden, et.al.; “Lysine Isotopologues, Compositions Comprising the Same

and Methods of Synthesis”, U.S. Patent No. US 9,840,457 B2 (Dec. 12, 2017).

M.D. Schwinden, et.al.; “Process for the Preparation of Tetrazole-DerivedCompounds as Growth

Hormone Secretagogues,” U.S. Patent Application No. US 2005/0096466 A1 (May 5, 2005).

Five Additional Patents

PUBLICATIONS “Process Research and Development for a Tetrazole-Based Growth Hormone Secretagogue (GHS)

Pharmaceutical Development Candidate”, Davulcu, A.H.; Schwinden, M.; et.al. J. Org. Chem.

2009, 74, 4068-4079.

“Enzymatic Synthesis of L-6-Hydroxynorleucine”, Hanson, R.L.; Schwinden, M.D.; et.al. Bioorg.

Med. Chem.1999, 7, 2247-2252.

“An Approach to Aflatoxins Using Type II Photocyclization Reactions,” Kraus, G.A.; Thomas,

P.J.; Schwinden, M.D. Tetrahedron Letters1990, 31, 1819-1822.

Six Additional Publications.

REFERENCES Available on request

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