Tergus is more than a team of people, it is a family. We believe in understanding each individual’s requirements and provide them with the opportunity to learn and grow. Employees are encouraged to engage in continuous learning and be ahead of the curve. Training is provided on a regular basis to facilitate professional growth. Our focus is to learn every day and produce quality work. In addition to maintaining strong technical acumen, Tergus peers guide each other every step of the way. We have key people in each business unit who work towards making Tergus a leader in topical product development.
Aletta Barnes-Baker has over 20 years of pharmaceutical industry experience. Upon graduating from Winthrop University with a Bachelor’s of Science in Biology, she started her career as an Integrated Science Teacher with Charlotte Mecklenburg School System. She then embarked on a career with Procter and Gamble (P&G) as a Chemist in the Over-the-Counter Medicine (OTCM) department and then transferred into Research and Development where she began method development in the Oral Care Division.
Aletta later expanded her career into Validation. She worked as a Validation Engineer with Fluor Daniels, validating systems and equipment for large pharmaceutical companies such as Eli Lily and Genentech. Aletta’s validation experience and knowledge forwarded her career and awarded her an opportunity as a Sr. Validation Engineer with Harmony Labs (currently Ei,LLC). While at Harmony Labs she developed the validation system used during Harmony’s site expansion. Aletta’s growth within Harmony channeled her career into the Project Management field where she managed several Rx and OTC projects simultaneously.
Aletta holds a Master in Business Administration (MBA) from Webster University and is a Project Management Professional (PMP) ®.
Outside of work she loves spending time with her family, traveling and cheering on the Carolina Panthers.
As Manger, Analytical Development at the Kannapolis Site (EnDev), Amanda oversees the laboratory testing of Lab Batches, Process Development, Line Trial, Informal Stability, and Registration Stability samples to support regulatory filing and submission. Having led a group to reduce a backlog of over 400 samples, in this role, Amanda is committed to having product tested/reviewed/and released in a timely manner to Clients. Amanda also supports the day to day activities within EnDev to unsure continuous workflow and continuous stock of supplies.
Amanda began her career as a Raw Material Chemist with Harmony Labs (formally Ei). Prior to joining Tergus, Amanda has served as Finished Product Chemist, Analytical Scientist, Project Manager, and Manger, Laboratory Sample Analytics with Ei/EnDev.
Amanda earned a B.S. in Pharmaceutical Sciences from Campbell University.
As Kannapolis Site Leader (EnDev), Charles oversees the day to day management of all site-specific activities and ensures that site operations are appropriately aligned with Tergus’ corporate objectives. In addition, Charles provides leadership to Tergus’ customer engagement activities which include the following:
- New Customer Onboarding
- Program Management
- Strategic Resource Planning and Deployment
In this role, Charles is committed to ensuring an unparalleled customer experience throughout the project lifecycle.
Charles began his career as a CMC Reviewer with US FDA and later served as a Consumer Safety Officer. Prior to joining Tergus, Charles has served in a variety of industry leadership roles that include Chief Scientific Officer of EnDev Laboratories, Director, Global CMC Regulatory Affairs, with Stiefel Laboratories, and Executive Director, Global Product Development, with Stiefel, a GSK Company.
Charles earned a B.S. in Chemistry from The College of William and Mary and a Ph.D. in Synthetic Organic Chemistry from Virginia Commonwealth University.
Gary Byrd is an experienced mass spectrometrist, specializing in quantitative and qualitative small molecule applications. He joined EnDev in November 2016 after working in government, private, and academic positions. After receiving a B.S. in Chemistry from UNC-CH and a Ph.D. in Analytical Chemistry from Purdue University, Gary began his career as a post-doc at the National Institute of Standards and Technology where he continued on as a research scientist in the Organic Analytical Division. He returned to North Carolina and worked for R.J. Reynolds for several years before joining the spin-off drug discovery company Targacept. At Targacept, Gary operated a high-resolution LC-MS system for a variety of projects, including pharmacokinetic studies, metabolic pathway determinations, and impurity identifications. He later spent three years working in the Small Molecule Group of the Core Mass Spectrometry Facility at Harvard University on a broad range of projects supporting the local research community. He returned once again to North Carolina. Gary is a member of the American Society for Mass Spectrometry..
JP joined EnDev in November 2016 having held positions of increasing responsibility as Director of Skin Biology with the Dermatology Therapeutic Area at GlaxoSmithKline (GSK), previously Stiefel, a GSK company and Stiefel. Prior to joining Stiefel/GSK, JP spent 6 years at the National Cancer Institute/National Institute of Health on the Dermatology Branch as Post-Doctoral and Research fellow working on human skin gene therapy. JP received a B.S. in Biochemistry from University of Sherbrooke (Quebec, Canada) and Ph.D. in Molecular & Cellular Biology/Photobiology from Laval University (Quebec, Canada). JP brings more than 20 years of experience in dermatological research and more than 9 years of experience in topical product development for both, prescription (Rx) and consumer healthcare/cosmetic (Cx) products, where his work has been extensively published in high-impact journals, scientific presentations, patent applications, and sale aids. JP is also a member of the Board of Directors of the Society of Investigative Dermatology.
Dr. Thakker is Co-Founder Emeritus of Tergus and is a pioneer in functional testing for semi-solids. Under her leadership, Tergus has emerged as the recognized global leader in developing release rate methods for semi-solid dosage forms.
She was involved in the development of in Vitro Release Testing (IVRT), recognized as an essential testing protocol for Semi-solid dosage forms. Her work led to the development of the SUPAC-SS guidance document that the pharmaceutical industry follows. She was also a member of the USP’s Advisory Panel from 2010-2015, and helped draft chapters 3 and 1724, and also a member of USP’s Expert Committee on Dosage forms.
Dr. Thakker earned her PhD in Pharmaceutical Chemistry at the University of Kansas. She worked at US Pharmacopeia for 12 years, where she specialized in the development and validation of dissolution methods in the Drug Research and Testing Laboratory. Dr. Thakker has also held leadership positions at Sphinx Pharmaceuticals and BioAnalytika Laboratories.
With the emergence of newer, alternative dosage forms over the past 10 years, she has surfaced as a well-recognized global leader in the development of topical drug products, providing expertise in the development and validation of performance tests used to evaluate the transport of drugs across skin and other membranes (e.g., buccal, sublingual, vaginal, rectal). Working with compendial and regulatory organizations, Dr. Thakker continues to strive toward improving public standards for topical and other dosage forms.
Mike joined Tergus in the capacity of Vice President, Business Development. In this capacity his early focus will be in the areas on identifying processes aimed at developing and onboarding new business opportunities that fit Tergus’ current business model and implementing growth opportunities between multiple organizations.
Mike joined Ei LLC in December 2009 (then Harmony Labs) and held positions of increasing responsibility until serving in his final capacity as VP of Business Development. While at Ei Mike was the top performer in onboarding new business at Ei every year. This included cosmetic, OTC, branded Rx and generic Rx clients and projects. Finally, Mike was a key member in creating, launching and promoting EnDev Laboratories along with its new skin biology capabilities.
Prior to Ei and EnDev, Mike held a several Director level positions within DPT Labs, over a span of 10 years, in support of its growth as a Contract Development Manufacturing Organization for liquids and semi-solids. These roles included Director, Strategic Business Unit, Director of Project Management and Director of Business Development. Prior joining DPT Labs, Mike worked as the Worldwide Director of Marketing for the Sharps Disposal division of Becton Dickenson. Additionally, Mike held positions of increasing responsibility in the Sales department and the Marketing department of KCI (now Acelity), culminating with the role of Director of Marketing. Mike began his career in the medical industry as Registered Nurse where he completed his bedside career in the Burn ICU at Harborview Medical Center in Seattle WA. Mike received a B.S. in Nursing from the University of Washington and an MBA from Boise State University.
Ravi leads a team of analytical scientists on multiple projects for providing pre-formulation/formulation support with studies including solubility, Drug-Excipient Compatibility, DOE, and prototype stabilities. He is an analytical point of contact for clients and represent the group in client meetings. He is very proficient in the development of stability-indicating HPLC methods, phase-appropriate validations, and method transfers to support topical drug product development. Apart from early R&D, his team occasionally provides support for GLP/GMP manufacturing campaigns with release and stability.
He has a Master’s degree in Pharmaceutical Sciences from Campbell University with a focus in Industrial Pharmacy. He was inducted in Rho-Chi Pharmaceutical Honor Society for his academic excellence. With his pharmaceutical background, he takes interest in formulation development as well.
Outside work, Ravi is a foodie, plays ping-pong and an aspiring runner. He loves to travel and learn about different cultures.
Tammy leads the Analytical and R&D team and insures that they consistently produce accurate, sound analytical data by inspiring them to execute laboratory analyses precisely and efficiently in accordance with GMP/GLP standards. She comes to Tergus with 12+ years of experience in analytical services and method development/validation in the pharmaceutical contract manufacturing industry providing strong leadership to drive quality results.
Tammy earned a B.S in Chemistry from the University of Houston and began pursuing a fast-growing career in the pharmaceutical industry. Her continuous drive to help others by providing mentorship, fostering academic growth and excellence in the scientific community has made her a tremendous asset.
Dr. Nalamothu is CEO & Co-Founder of Tergus Pharma and has been a leader in topical pharmaceutical development for more than two decades. He holds several patents and his efforts have led to a number of successful commercial products. His passion is to develop products that speak for themselves, leading him to be a co-founder of Tergus, shepherding the company to its industry leading position in the marketplace.
After earning his PhD in Pharmaceutics from the University of the Science’s Philadelphia College of Pharmacy, he worked at Sanofi-aventis Worldwide Dermatology (Dermik) as the Head of the Early Compound Assessment and Preclinical Group. He has also served as Global Head of Dermatology R&D at Promius Pharma, a wholly-owned subsidiary of Dr. Reddy’s Laboratories, where he spearheaded the development of specialty branded dermatological products from concept to commercialization.
Dr. Nalamothu’s interests include novel dosage form design and development of topical drug products. His commitment to quality and excellence led him to create the first Quality by Design (QbD) program for topicals, numerous articles and accolades. He is a sought-after speaker at conferences worldwide.
Alon serves as a Skin Biology Scientist III with the responsibility of conducting various studies and developing novel assays using ex-vivo human skin models. Such experiments include validation of target engagement, skin irritation testing, effects on pigmentation and more. Alon brings over 13 years of practical knowledge of human skin structure, function, and pathology. His previous work at academic settings focused on the investigation of molecular processes that regulate human skin barrier, phototoxicity, inflammation, skin cancer, hair loss, and abnormal scars.
Prior to joining EnDev/Tergus, Alon received his training in skin biology at the department of dermatology at the University of Rochester, NY, and served as a Research Associate at Hampton University Skin of Color Research Institute in Virginia.
Alon earned a bachelor’s degree in Biotechnology Engineering in Israel and a PhD in Pharmacology from the University of Rochester, NY. His work on human skin function and disease has been published in top journals and received several awards and recognitions by his peers.
In Bethany’s experience with Tergus Pharma, project management and work flow are the key components to leading the IVRT team. Working with the IVRT team has taught her how a successful group of people can work in concert with one another to achieve quality and compliance together.
With over 15 years of experience in Pharmaceutical Chemistry, Bethany began her career as a QC Chemist running stock methods for stock products in large Pharma. For the last 10 years, she has spent her career in CROs which lent her the ability to learn about and analyze multiple forms of pharmaceutical dosing.
Sr. Director Human Resources & Organization Effectiveness
Duffy leads the human resource and organization effectiveness strategy with Tergus. In this capacity, the core focus aligns human resources with the business strategy. This alignment focuses on turning Tergus’ human resources into a sustainable competitive advantage to optimize organizational effectiveness and deliver operational excellence and value creation for Tergus’ customer base.
The human resource systems deployed in this process are:
- Talent identification and capabilities assessment
- Leadership and work force development
- Encouraging cross function communication and collaboration
- Performance measurement, reward and recognition systems for high performance
- Total compensation and benefits
- Succession planning
This systems focus will ensure that Tergus continues to be an employer of preference and world class in its competitive market space.
Duffy began his career with the 3M Company in manufacturing, quality systems and human resources. His most recent experience was with LipoScience of Raleigh, NC, an in-vitro diagnostic cardiovascular test, technology platform, and CRO. During his twelve years with LipoScience, Duffy provided leadership in human resources, laboratory operations and quality assurance and regulatory systems. LipoScience was acquired by the Laboratory Corporation of America in 2014.
Sr. Director Quality Assurance
Dawn is a seasoned professional with 33 years of extensive experience in Quality, Regulatory and Compliance in the pharmaceutical industry. In her role as Senior Director, Quality Assurance, Dawn will provide executive leadership and direction to the Quality Assurance functions at the Tergus RTP and Kannapolis sites. Her experience spans pharmaceutical, cosmetics and over-the-counter products working for large international pharma and for CMO’s. Dawn is committed to creating and nurturing a strong Quality culture that focuses on systems thinking, protecting assets and ensuring adherence to regulatory requirements.
Dawn began her 31 year career at GSK as a chemist/scientist in the Quality labs in roles of increasing responsibilities followed by experience in CMC, Global Regulatory Affairs, Import/Export Compliance; DEA Compliance Management. Prior to joining Tergus Pharma, her most recent role at was as Director, Regulatory Compliance at Mayne Pharma and included oversight of Documentation Management, Vendor and Client Audits and support of Regulatory Agency inspections. Dawn received a B.S. in Chemistry from Lee University in Cleveland, Tennessee.
In her spare time, Dawn enjoys spending time fishing in the rivers of Eastern North Carolina and ocean with her husband, relaxing in the beautiful Blue Ridge Mountains of NC, working out, and volunteering to support disabled veterans.
James has worked in the pharmaceutical industry for 7 years and currently holds the position of Analytical Scientist II at the Kannapolis site. He primarily works on analytical method development and validation in support of formulation development projects. Prior to joining EnDev and Tergus James was a Team Leader in the Method Development and Validation group at Mayne Pharma in Greenville, NC. His focus there was supporting customer projects from early phase formulation development through to commercial manufacturing. A big emphasis in James’ time there was to develop phase appropriate approaches to method validation in order to streamline projects for our customers. Outside of work he enjoys running, mountain biking, skiing and travelling.
Monica Germann works as the Senior Manager of IVPT. She works towards providing bioanalytical results for client studies. She has a strong LC-MS/MS background, and she has enjoyed working on developing novel methods for her clients.
Monica has been active in the bioanalytical business for the past 15 years, working in all areas from sample management through data reporting. Her experience has ranged from non-regulated to GLP and GMP regulated work, including method development, method validation, and routine sample analysis.
She enjoys cooking and spending time with her family. Trips to the library and travel in the area are her weakness.
Srikanth Manne works as Principal Scientist at Tergus Pharma leading a team with a focus towards development of various Topical dosage forms in branded NCE and complex Topical Generic formulations. He is an expert in materializing the design of experiments, QbD and in the development of the strategies for biowaiver during the development of formulations.
He has over 10 years of experience in formulation and development of 505(b)(2) and complex generics (ANDA), having been associated with Dermatology R&D, Dr. Reddys Laboratories and Martindale Pharma.
Srikanth Manne obtained his Masters in Industrial Pharmaceutics from University of Greenwich and Bachelors in Pharmacy from India.
Vekarious is a member of the Kannapolis Site team where he provides analytical support for pre-formulation/formulation efforts. He develops and validates stability-indicating methods that are phase-appropriate, and supports early formulation development efforts such as solubility studies, drug-excipient compatibility studies, and DOE studies.
Vekarious has 7+ years of experience in analytical development/validation. He also has acquired skills in operational excellence and advanced statistical treatment of data. He earned a M.S. in Pharmaceutical Sciences from the University of Florida and a B.S in Chemistry from Florida State University.
Outside of work, Vekarious studies fragrances and is an aspiring perfumer. He also has novice studies in the ancient Greek language, in which he also aspires to become a proficient reader of Ancient Greek Literature.
William (BJ) Schaefer joined Tergus in the capacity of Director, Technical Operations and Quality Control. In this capacity his early focus will be in the areas of manufacturing operations and quality control. His ASQ-Certificate as a Six Sigma Black Belt will be highly relevant as we evaluate methods and improve our processes and outcomes.
BJ graduated from Southern Illinois University with a BS in Physics along with a secondary teaching certification. Although learning is still a passion, BJ quickly transitioned into industry and landed in a medical device company that manufactures radiation treatment planning software and hardware. This opportunity opened doors in other regulated industries such as radiopharmaceutical, pharmaceutical, cosmetic and food. BJ has held roles with increasing responsibilities in research, process improvement, technical transfer, quality and manufacturing and within both small and large organizations such as Multidata, Mallinckrodt, KV, Patheon, ConAgra, GSK, Virbac and Ei Solutionworks.