Jeff Atkinson

• Collaborated with other members of the Executive Leadership Team to set objectives and strategic direction
• Led the on-time delivery of IND-enabling CMC activities (inclusive of DS and DP) for the NSCLC program (modality – mRNA LNP) including the writing of IND sections
• Partnered with Research and Early Development, Manufacturing, Quality, Regulatory Affairs, Clinical Operations, and Program Management to ensure on-time delivery of DS and DP for multiple programs
• Successfully led and managed cross-functional internal and CDMO teams to complete complex investigations to maintain clinical supply or overcome roadblocks in development
• Drove the implementation of a continuous process verification-like program to monitor drug substance and drug product manufacturing parameters for a clinical stage product
• Authored or reviewed CMC sections and responses for regulatory submissions (IND, IMPD, CTA)

Previous titles include Executive Director, Process Development and Analytical Sciences (Sep 2022 – Mar 2024)

• Enabled maintenance of Onivyde (liposomal irinotecan) stock and safety stock through multiple critical manufacturing and analytical testing investigations by leading internal and CMO investigation teams to find the root cause, implement corrective and preventative actions, release the batch, if possible, or work with the CMO to expedite manufacturing to replace the rejected lot, if necessary
• Increased process and product quality and robustness by working cross-functionally and cross-site to develop and implement process and test method improvements both internally and at CMOs and CTOs
• Led teams responsible for the development and implementation of multiple process and analytical lifecycle management and continuous improvement changes accepted as post-approval changes by the FDA, EMA, and PMDA
• CMC lead and MSAT subject matter expert for regulatory inspections (foreign and FDA) as well as for Type C meetings and post-approval filings resulting in positive outcomes
• Established a commercial-to-commercial tech transfer process and directed process and product characterization and PPQs resulting in the successful transfer of Onivyde drug product manufacturing and testing from a CMO to an internal manufacturing site and bulk drug product manufacturing and testing from one Ipsen manufacturing site to another
• Led the Global External Development and Manufacturing Leadership Team (EDMO-LT) to establish knowledge sharing across sites about CDMOs used in the Ipsen network and best practices in CDMO management

Previous titles include Head of Process Science (Sep 2017- Jun 2021)

• Built and developed the formulation and analytical development team from 8 scientists to 27 scientists, engineers, and technicians increasing work capacity from 5 to 20 programs
• Developed a risk-based product development process encompassing technical, timeline, safety, and business risks and implemented it for all projects regardless of development stage to proactively identify, communicate, and mitigate potential risks enabling robust decision-making
• Established customer project process flows using a stage-gate process for product development from feasibility through completion of Phase 3 manufacturing including technology transfer in and out at any stage of the product lifecycle resulting in a better CDMO experience for customers

Previous titles include Manager, Research and Development (Oct 2012 – Apr 2013), Process Development Consultant (Nov 2011 – Oct 2012)

• User Design Representative for the development labs and GMP manufacturing areas of the SurModics Pharmaceuticals’ brown-field facility expansion resulting in a modern, flexible, multipurpose facility
• Authored or reviewed master validation plans for equipment, facilities, and processes for expansion project
• Developed URSs and validation documents for manufacturing and development areas and equipment
• Led multiple technology transfer projects for large pharmaceutical and biotech customers utilizing complex parenteral delivery technologies

• Company Overview: (Wholly owned subsidiary and spin-off of Southern Research)
• Project manager and lead scientist for the two highest revenue clients with projects budgets equal to approximately half of company revenues
• Developed strategy, authored procedures (SOPs, batch records, work instructions), managed equipment specification, purchase, install and validation for the first clinical aseptic manufacturing project at Brookwood in less than 3 months

Previous titles include Project Manager/Senior Scientist (Apr 2005 to Sep 2006), Associate Chemist III (Jan 2005 – Apr 2005)

• Lead scientist for process development of a microencapsulation process taking it from IND-enabling studies through process characterization and Phase 3 clinical manufacturing including scaling up from 100 g to over 7 Kg
• Scaled-up (~1 Kg to ~70 Kg) and led process characterization of a bulk drug product manufacturing process post-Phase 1 through registration and stability

Previous titles include Associate Chemist II (1999 – 2003), Associate Chemist I (1998 – 1999), Assistant Chemist I (1996 – 1998)