Syner-G BioPharma Group

Sarah (Hlavachek) Mohs, a CMC Regulatory expert, joined Syner-G BioPharma Group in 2016. With over 25 years of experience, she excels in developing small molecule and biotech drug products, drug-device combinations, and medical devices. Sarah is a leader in program management and team building. She has successfully managed numerous global clinical trials and marketing applications, and is well-versed in US, Canadian, European, and Japanese regulations. Her technical writing and communication skills facilitate effective cross-functional collaboration. Specializing in late-stage CMC development and expedited programs, Sarah’s previous roles include positions at TARIS Biomedical, Stryker Biotech, Sepracor, and PPD Development. Sarah specializes in formal meetings with Health Authorities including Type B, C and D meetings with FDA and Scientific Advice with EMA. She holds a Chemistry degree from the University of Wisconsin, Madison. Join us in celebrating Sarah’s remarkable contributions. #Biopharma #CMCRegulatory #DrugDevelopment

In conjunction with Mental Health Awareness Month, Syner-G’s Walk to Well-Being challenge has become our flagship virtual engagement event. With the aggressive goal to walk 19,500 miles during the Month of May, the distance between North America and India Syner-G locations and where heavy concentrations of our employees reside, we assembled 63% of our workforce (143 employees) and walked first as a company (#oneteam) to foster our culture of collaboration, in teams (18 in total) to build community, and as individuals (143 employees) to meet personal well-being goals, #inspiring each other on the virtual walking trails. We achieved our goal in 35 days with walking paths taking us across the globe, up mountains (literally), along city sidewalks, to three oceans, in our home offices, and enjoyed some incredibly scenic views along the way. We walked alone, with family, friends, and colleagues. We had a blast and we built some healthy habits along the way. No challenge is complete without a small dose of competition and we wish to spotlight 3 individuals who walked the most steps during our challenge: Congratulations to Sahana Raju, Kasinath Baratam, and Anuradha Pandurangaiah, who each walked over 500 miles. Also, a big congratulations to the team who led our organization across the finish line – The Wanderlust Walkers collectively who walked 1,688 miles. It was a remarkable and inspiring event and we are already looking forward to 2025. #weinspire #well-being #oneteam

Lyndon Marble is key leader at Syner-G BioPharma Group and excels in project management, team building, and guiding multidisciplinary teams to meet timelines and budgets. His expertise includes project strategy evaluations, timeline management, route selection, process optimization, and cGMP kilo lab process development. Lyndon guides CRO/CMO/CDMOs to support drug development activities and ensures meticulous project documentation. With a strong background in chemistry, he has successfully guided process teams and contributed to several CMC sections. His prior experience includes Laurus Synthesis, Concert Pharmaceuticals, and Johnson Matthey Pharma Services. Lyndon has contributed to four scientific publications, completed three patents, and contributed to three IND CMC sections. Join us in celebrating Lyndon’s remarkable contributions! #Biopharma #DrugDevelopment #TechTransfer

Today we celebrate the spirit of independence and wish you a joyful and safe July 4th! #4thOfJuly #IndependenceDay

Explore the intricacies of clinical study protocols with our latest blog, "Understanding the Nuances of a Clinical Study Protocol," by Maria Fairbank, PhD, Senior Clinical Research Scientist at Syner-G BioPharma Group. Gain valuable insights on overcoming common challenges, assembling the right team, and tips for developing a robust and effective protocol. This guide is essential for medical writers and clinical researchers aiming to enhance their protocol writing skills. Read the full blog here: https://bit.ly/4eCSCVO #MedicalWriting #ClinicalResearch #ClinicalTrials

Meet Deborah Quick, Ph.D., a CMC Development expert at Syner-G BioPharma Group since 2011. With over 22 years of experience, Deb excels in troubleshooting cell culture and fermentation processes, developing bioassays, and manufacturing cell therapies. Deb provides technical expertise in process scale-up, technology transfer, and clinical/commercial manufacturing. Her skills in designing experiments and process validation are invaluable. She is also involved in gap assessments, risk assessments, regulatory filings, vendor audits, and client audit preparations. Join us in celebrating Deb's extensive experience and dedication to her field. #EmployeeHighlight #CMCDevelopment #Biopharma

Meet Kirsten Lewus, MS, a member of Syner-G BioPharma Group with 19 years of experience in technical and quality assurance services. At Syner-G, Kirsten provides top-tier Quality Assurance support, overseeing early and late-phase clinical products. She excels in establishing Quality Management Systems, batch release, and ongoing quality management for small and large molecule and autologous cell therapy products. Kirsten’s extensive technical expertise includes process development, manufacturing support, technology transfer, and CMC regulatory filings. Her background includes significant roles at Amgen, where she supported the development and scale-up of monoclonal antibody and fusion protein processes, and at Merck in vaccine bioprocess development. Kirsten's commitment and expertise are instrumental in driving quality and innovation at Syner-G. #EmployeeHighlight #Biopharmaceuticals #QualityAssurance

Our latest on-demand webinar explores the critical aspects of formulation and analytical considerations in preclinical and early-phase pharmaceutical development. In the early phases of clinical drug development, several factors need to be balanced so that a robust data set can be generated while supporting a timely start to the FIH study when limited funding may be available. This webinar is designed to equip researchers, scientists, and professionals in start-up and small biotech companies with effective strategies for early-phase formulation and analysis, facilitating phase-appropriate progress and helping them reach their next funding milestone successfully. Watch on-demand now: https://bit.ly/3xG0Pb1 #PharmaceuticalDevelopment #Biotech #Webinar

Syner-G BioPharma Group spotlight on Raymond Nims, Ph.D., a key figure in our CMC Development team with a focus on Virology. Dr. Nims joined Syner-G in 2009, bringing with him over forty years of experience in biomedical sciences, including significant roles in viral safety and mycoplasma testing. His career highlights include GMP positions at Amgen and BioReliance, where he directed lot release testing including viral safety evaluations for biologics. Dr. Nims is also an active contributor to professional journals and advisory boards, further enriching the biopharmaceutical field with his broad expertise spanning chemistry, biochemistry, and virology. We are proud to have Raymond on our team, where his depth of knowledge continues to drive our commitment to advancing safe and effective therapies. #CMCDevelopment #Virology #EmployeeSpotlight

The pharmaceutical industry is poised for a major advancement with the introduction of eCTD 4.0, set to enhance the efficiency and flexibility of regulatory submissions worldwide. Our latest blog by Jeff Golden explores how this new version will streamline processes and improve outcomes. eCTD 4.0 promises to transform regulatory submissions, benefiting sponsors, health authorities, and patients. Read more about this pivotal change and prepare for the future: https://bit.ly/3RIZmYu #eCTD #Pharma #RegulatoryAffairs