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.


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


• 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

• BS or MS in Chemical Engineering, Biology or related discipline, with 10+ years relevant experience

CONTACT: Peter Dellva, Head of Business and Finance

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.


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
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


• 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

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:

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.

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.

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.

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 or call 847-730-3475.


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 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.

BioTechLogic speaks at 2011 PDA/FDA Process Validation Guidance Workshop


2011 PDA/FDA Process Validation Guidance Workshop:                    

Aoril 13-14, 2011

JW Marriott San Antonio Hill Country Resort & Spa
San Antonio, TX, USA

Kurtis Epp, Senior Manager, Manufacturing for BioTechLogic, will be presenting during Session P4 – Stage 3 Continuous Process Verification Implementation.  The title of his presentation is “Post Approval Process Validation Reporting.”  He will be available to meet with interested parties during the conference.

The mission of PDA is to advance pharmaceutical and biopharmaceutical technology internationally by promoting scientifically sound and practical technical information and education for industry and regulatory agencies.

BioTechLogic exhibits at IBC’s 13th International Process Validation Exhibition


BioTechLogic will be exhibiting at IBC’s 13th International Process Validation for BioPharmaceuticals Conference & Exhibition 2009 in La Costa, California.  The conference, which runs from March 2-3, is co-located with the Outsourcing Manufacturing of Biopharmaceuticals and the Technology Transfer for Biopharmaceuticals conferences.

Exhibiting at the Process Validation conference will provide additional opportunities for continued growth in BioTechLogic’s technical offerings.

“We look forward to the opportunity to showcase our capabilities to a wider audience with bioprocessing needs.” – Peter Dellva, Head of Business and Finance.


Brief from PDA workshop on FDA Guidance for Process Validation



  1. The FDA’s Draft Guidance on Process Validation is nearing approval stage.  It has been circulating within the industry for comments for a year and FDA is committed to finalizing by the end of 2009.
  2. This was the fourth of five workshops to discuss the new guidance document and to solicit feedback from the industry.  Consequently, the focus of discussions at the PDA workshops has shifted over the course of the year from review to implementation.


  1. The concepts contained in the draft guidance document are not revolutionary.  In many ways, they reinforce what we (BioTechLogic) are already doing.
  2. What we sense as different is a renewed focus on Stage 1 (Process Design) and Stage 3 (Continued Process Verification) during PAI and CMC review.
  3. While we already knew this, “Process Validation” is now being considered as a progressive sequence of activities rather than as an event.  Three consecutive successful full-scale batches is now a minimalistic approach.

Stage 1 (Process Design):

  1. Design of Experiment (DOE) during process development is now a must.  Single variable experiments that lack an evaluation of interacting parameters are not sufficient for gaining process knowledge and defining Critical Operating Parameters.
  2. Process Characterization Reports should include a full discussion of both “design space” and interacting parameters.  Statistical evaluation of experimental data is crucial.

Stage 2 (Process Qualification):

  1. Overall, this stage is very much the same.  The biggest change is that FDA is very hesitant to use the term “three consecutive batches” to describe Process Qualification (PQ).  “As many as it takes to demonstrate process control” is the new mantra.
  2. Additional sampling throughout PQ was emphasized.  It was also noted that additional sampling should continue after PQ and into Continued Process Verification (CPV) until the appropriate process knowledge is gained.

Stage 3 (Continued Process Verification):

  1. There is a strong emphasis on Statistical Process Control (SPC) for this stage.
  2. Whereas commercial data evaluation in the form of an annual report was previously expected, more frequent monitoring and formal internal reporting will be expected.
  3. Investigators are now being trained to inspect commercial sites one to two years post-approval to specifically evaluate: (1) maintenance of a validated process (i.e., CPV), (2) stability data, and (3) quality of incoming materials and components.
  4. The agency strongly recommends a formal protocol for CPV.