Join BioTechLogic at BDP Week at the Hyatt Regency Resort and Spa, Huntington Beach, California March 30 – April 2, 2015. Receive a 20% discount off the standard conference rates to attend BDP Week by entering priority code BDP15SPX11 when you register online at www.IBCLifeSciences.com/BDPWeek or by calling 800.390.4078.
posted on February 23, 2015 by
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Meet BioTechLogic at BDP Week in Huntington Beach and get 20% off!
posted on November 13, 2014 by
BioTechLogic now hiring – Process Validation!
BioTechLogic is accepting applications for a Manager of Technical Operations. Join our dynamic consulting team and work with clients around the world, helping them bring biopharmaceutical projects to market.
JOB DESCRIPTION
Title:
Manager, Technical Operations
Essential functions:
• Manage project activities within the BioTechLogic Technical Operations group enabling fulfillment of client contracts
• Manage the validation of biotechnology processes within the Technical Operations group
• Develop and review validation plans, including specific process development and validation strategies
• Ensure development and validation documentation is suitable for regulatory submission
• Establish personal development plans for the Technical Operations group, contributing to the continuous improvement of knowledge and experience within the company
• Effective tracking and communication of project progress and status to team members and clients, via e-mail and teleconference
• Lead meetings via teleconference or face-to-face
• Provide detailed input to clients, enabling informed decisions on process development and/or process validation strategies
• Provide on-site support at physical meetings, including those at contract manufacturers for information gathering or in support of manufacturing operations
• Support BioTechLogic’s marketing efforts by actively seeking new clients and repeat business opportunities
• Author or co-author articles for industry-related publications
JOB REQUIREMENTS
Competencies:
• Experience developing overall strategies and managing validation plans for biologic processes.
• Extensive experience and high skill level in the generation, review and execution of process validation and supporting validation protocols and reports at both laboratory and manufacturing scale
• Experience presenting validation plans, protocols and reports to regulatory agencies
• Aptitude for rapid understanding of biopharmaceutical manufacturing processes and demonstrated ability to furnish optimization and troubleshooting
• Expanded knowledge of cGMP systems such as documentation, change control and deviations coupled with a profound understanding of the work process for development, scale-up and technology transfer at contract manufacturing organizations (CMOs)
• Flexibility, motivation and a willingness to accept additional projects
• Ability to drive completion of multiple simultaneous projects among the Technical Operations group
• Ability and willingness to travel
Education/Experience:
• BS or MS in Chemical Engineering, Biology or related discipline, with 10+ years relevant experience
CONTACT: Peter Dellva, Head of Business and Finance
847-730-3475
pdellva@biotechlogic.com
www.biotechlogic.com
posted on November 13, 2014 by
BioTechLogic now hiring – Analytical!
BioTechLogic is accepting applications for a Senior Consultant of Biotech Analytical Services. Join our dynamic consulting team and work with clients around the world, helping them bring biopharmaceutical projects to market.
JOB DESCRIPTION
Title:
Biotech Analytical Services, Senior Consultant
Essential functions:
• Simultaneous management of multiple biotechnology related analytical projects
• Develop, qualify and troubleshoot sensitive, efficient, and reliable analytical assays
• Prepare, review and edit method qualification and method validation protocols, analytical technical reports and CMC regulatory documentation
• Provide technical expertise and advice to project representatives and teams on topics pertaining to biotech pharmaceutical analysis and CMC development, including:
Assay development and selection
Structure-activity relationships
Product characterization strategy
Impurity identification
Quality-by-Design
Product quality attribute classification
Study design
• Present findings and/or results to senior client management
• Effectively communicate technical, scientific and project related issues to clients
• Provide technical guidance to clients enabling the resolution of challenging issues relating to biotech analytical methods
• Supervise activities of direct reports (if any) and provide performance evaluations, recommendations of appropriate training and encouragement in the skills required to enable career development
• Research and evaluate cutting edge analytical technologies, methodologies, and approaches that may enhance BioTechLogic’s analytical technical capabilities
• Be knowledgeable of prevailing technical and regulatory developments in the industry
• Provide scientific and analytical leadership to the BioTechLogic team
• Support BioTechLogic’s marketing efforts by actively seeking new clients and repeat business opportunities
JOB REQUIREMENTS
Competencies:
• Demonstrated excellence in time management
• Self-motivation
• Concern for standards
• Results orientation
• Thoroughness
• Initiative
• Creative Thinking
• Continuous Development orientation
Knowledge, Skills and Abilities:
• A robust understanding of analytical biotechnology including method development, method qualification/validation and global regulatory analytical requirements
• Laboratory experience performing method development, qualification and validation activities
• Demonstrated supervisory and managerial ability
• Demonstrated ability to thrive in a team environment
• Ability and willingness to travel
• Distinguished oral and literary skills
• Ability and confidence to make far-reaching independent decisions
Education and Experience:
• PhD in Mass Spectrometry, Analytical Chemistry, Biochemistry, or related discipline, with 5+ years relevant experience
CONTACT: Peter Dellva, Head of Business and Finance
847-730-3475
pdellva@biotechlogic.com
www.biotechlogic.com
posted on September 25, 2014 by
BIoTechLogic Exhibiting at IBC’s BioProcess International Conference and Exhibition, October 20-23, 2014 in Boston
Tracy TreDenick, Head of Regulatory and Quality Assurance, and Peter Dellva, Head of Business and Finance will be attending IBC’s BioProcess International Conference & Exhibition, October 20th -23rd, 2014 at the Hynes Convention Center in Boston, MA.
Featuring over 150 Speakers, 150 Exhibitors and 100 Posters, this years event features 6 focused conference tracks including Cell Culture and Upstream Processing, Manufacturing Strategy and Analytical and Quality.
Now in its 11th year, the BioProcess International Conference & Exhibition is ranked the #1 BioProcessing event by the industry. Attend BPI and make new connections in the field while strengthening current relationships. Network with the BPI advisory committee and speaker faculty, meet key industry associations and publication contacts, share new ideas with poster presenters and find new technologies from exhibitors and sponsors.
Please stop by Booth #509 to meet with Tracy and Peter to learn more about BioTechLogic’s Regulatory and Manufacturing services.
posted on April 15, 2014 by
Meet BioTechLogic at CMC Strategy Forum Europe 2014
Tracy TreDenick, Head of Regulatory and Quality Systems, Julie Spyrison, Associate Director, Regulatory Operations, and Rachel Houp, Senior Manager, Technical Operations will be attending CMC Strategy Forum Europe 2014 presented by CASSS. The program, which is scheduled for May 5-7, 2014, will be held at the Hilton Sorrento Palace in Sorrento, Italy.
The Forum will follow the established model of the CMC Strategy Forum series with focus on topics and regulatory updates followed by several technical sessions which will include discussions on comparability and similarity, drug substance process validation, QbD submissions for biologics, as well as lifecycle management for biotech products. Follow this link for more information: https://m360.casss.org/event.aspx?eventID=86019
BioTechLogic has extensive experience in providing CMC Regulatory Services and is looking forward to discussing the latest news from the program.
If you are attending, please let us know or look for us in Sorrento!
Tracy, Julie and Rachel would love to meet with you to discuss the forum or any CMC needs your company might have.
posted on January 17, 2014 by
20% Discount for IBC’s Biopharmaceutical Development and Production Week this March in San Diego
BioTechLogic, Inc. will be at exhibiting at IBC’s Biopharmaceutical Development and Production Week this March in San Diego. If are you not familiar with the event, you can check it out at: http://bit.ly/1drmqiC.
Plus, as an exhibitor, we have a discount code we can share with you to attend. This code is 20% savings off the standard conference rates. If you are submitting new registration, be sure to use priority code BDP14SPX11 to obtain the savings! We hope to meet with you there.
posted on January 15, 2014 by
BioTechLogic to Exhibit at IBC’s Biopharmaceutical Development & Production Week in San Diego, March. 24th – 27th, 2014
David Fetterolf, Director, Technical Operations and Rachel Houp, Senior Manager, Technical Operations will attend IBC’s Biopharmaceutical Development and Production Conference, March 24th -27th, 2014 at the Hilton Bayfront Hotel in San Diego CA.
Featuring over 175 Speakers, 65 Exhibitors and 80 Posters, this years event features 9 focused conference tracks including Viral Safety for Biologicals, Analytical Technology for Biotherapeutic Development and Antibody Development and Production for both upstream and downstream application.
Please stop by Booth #211 to meet with Dave and Rachel and learn more about BioTechLogic’s Regulatory and Manufacturing services.
posted on December 17, 2013 by
BioTechLogic Attends Society of Chemical Industry (SCI) Analytical Conference in London, November 14th, 2013
Alex Gibb, Manager Analytical Services attended the 2013 Society of Chemical Industry Conference ‘On-Line and At-Line Analytical Technologies in the Industrial Biotechnology Sector’ at the Institute of Practitioners in Advertising in Belgrave Square, London November 14th 2013.
Among the new technologies featured, Optim high throughput analysis and characterization for stability studies from Avacta shows a promising ability to predict activity and aggregation of proteins toward the end of shelf life. This exciting technology uses a combination of thermal stress and static light scattering that could have applications from clone and media screening to Bioprocess optimization.
SCI, a unique international forum where science and business collide gathered attendees for an interactive session of learning, networking and collaboration. Hailing from academia and industry, the attendees enjoyed an insightful look into the future of on-line and in-line analytical technologies.
http://www.soci.org/News/Separation-Science/Online-and-Atline-Conference-Papers-2013.aspx
posted on August 25, 2013 by
Senior Quality Control Expert Joins BioTechLogic
BioTechLogic, Inc., a biopharmaceutical manufacturing and CMC consulting firm, today announced the recent addition of Jennifer Holder to its expanding team of highly skilled technical experts and consultants.
As Manager of Analytical Services at BioTechLogic, Holder joins BioTechLogic with a focus on both technical and compliance aspects of analytical methodologies, including method development and optimization strategy; method verification, qualification and validation design; analytical troubleshooting; guidance in ICH and regulatory agency requirements; gap assessments; protocol and final report writing, technology transfer, implementation of new technology, oversight of third party testing laboratories, preparation of CMC regulatory documents for IND/BLA/MAA submissions, and performance of laboratory quality audits.
Holder was most recently a Remediation Scientist for Chemical Quality Control at Hospira, a global pharmaceutical and medical device company and leading provider of injectable drugs and infusion technologies. Holder has over 14 years industry experience with ten years in GMP testing laboratories. Jennifer has held positions at Diosynth, Biogen, Seattle Genetics, Novartis and Hospira, where she performed routine analysis and provided analytical technical support to Quality Control and Quality Assurance.
BioTechLogic has developed proven methodologies and approaches for providing reliable and dependable services to clients in the pharmaceutical industry. For more information about BioTechLogic, visit www.biotechlogic.com or call 847-730-3475.
posted on July 9, 2013 by
Alex Gibb Joins BioTechLogic as Manager, Analytical Services
(Glenview, IL) July 9, 2013 – BioTechLogic, Inc., a biopharmaceutical manufacturing and CMC consulting firm, today announced the addition of Alex Gibb to its growing team of technical experts and consultants. As Manager, Analytical Services, Gibb will support clients by developing analytical method validation and qualification strategies, preparing method validation and qualification protocols and reports, reviewing internal reports to identify gaps in ICH and regulatory compliance, providing guidance on method requirements and capabilities, providing consultancy on technology transfer, managing third party CRO and CMO testing laboratories, preparing CMC regulatory documentation for IND/BLA/MAA submissions, and performing QC and laboratory audits. Alex was most recently at Novartis Vaccines and Diagnostics in their Analytical Services group, the world’s fifth-largest vaccines manufacturer and the second-largest supplier of influenza vaccines in the United States.
“We’re experiencing a critical time of company growth, and Alex enhances our team’s ability to continue to provide a tremendous breadth of analytical expertise and knowledge,” said Patrick Giljum, Head of Operations, and co-founding Partner of BioTechLogic.
Alex brings over thirteen years experience in the biopharmaceutical industry. In addition to Novartis, he has previously held various positions with Amgen, Sirna Therapeutics and Eltron Research, where he provided analytical technical support; and developed, transferred, qualified and validated methods including UV, HPLC, SDS-PAGE, and MS based methods. Alex has a BSc (Hons) in Ecology with Biology from the University of East Angila, Norwich, United Kingdom.
BioTechLogic has developed proven methodologies and approaches for providing reliable and dependable services to clients in the pharmaceutical industry. For more information about BioTechLogic, visit www.biotechlogic.com or call 847-730-3475.
About BioTechLogic
BioTechLogic, Inc., is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization’s technical, manufacturing, analytical, and regulatory resources. The firm offers expertise in process development, BioAnalytical services, process validation, project management, quality assurance, regulatory submissions and Pre-Approval Inspection (PAI) readiness. BioTechLogic’s quality by design (QbD) approach enables the company to effectively provide product development support, including: development reports, design of experiments, technology implementation, critical process parameter evaluation, technology transfer and scale-up, and on-site third party contract manufacturing support.
