Douglas Rank Email & Phone Number

Littleton, Ma, Us

Wilmington, Ma, Us

Burlington, Ma, Us

• Led the Upstream & Support group within MilliporeSigma’s CDMO site responsible for process development, generation of pre-clinical material, and completion of technology transfer/investigations to support cGMP. • Group support responsibilities include the procurement, shipping, and inventory for the Burlington CDMO site. • Built a new team of six upstream & support staff which consistently demonstrate high performance executing customer studies on time and on budget.• Developed internal project framework for the professional development of operations team. The resulting teams have successfully identified and addressed gaps in several areas (safety, lab jobs, and inventories) while gaining leadership/ project management skills.• Developed tools and improved upstream documentation focusing on improved operational clarity and repeatability (SOPs, work instructions, batch records, training documentation, etc.).• Completed 2nd lab buildout (~3000 ft2; $3.42 mil budget) including IQ/OQ of select equipment (with site leadership).

Burlington, Ma, Us

• Led an upstream team of three scientists/engineers to identify critical customer needs in the development of next generation processes. • Developed industrially relevant perfusion processes, evaluated/implemented next gen sensors/analytics, and executed ‘sandbox’ projects including benchtop factory of the future, intensified seed train/HD cellbanking, and others focused on driving confluence of process & digital. • Developed and established an Agile workflow to manage innovation projects focused on clear project proposal/success criteria and project/milestone breakdown (with Agilist). Implementation within the R&D team improved project prioritization and maximized productivity. In addition, approach helped team develop leadership skills giving them ownership and providing visibility and transparency.• Led the upstream workstream within an internal strategic initiative later rebranded as the BioContinuum™ Platform.

Burlington, Ma, Us

• Evaluated new product prototypes and generated applications data for existing product lines (Mobius® single-use bioreactors and mixers, cell culture media, Cellicon™).• Established internal perfusion capabilities and technical guidance for using ATF and ssProstak cell retention devices.• Scouted early technology and external product opportunities, proposed proof of concept/performance demonstration studies to senior R&D management and executed as projects to support product development.

Burlington, Ma, Us

• Led a team of three scientist/engineers responsible for protein production (mg to multigram scale) and expanded company capabilities from 293 transient expression to CHO cell line development.• Evaluated commercially available selection systems for use in Dyax’s upstream platform and made short- and long-term recommendations to senior leadership. • Developed and established new CHOK1SV-GS cell line generation procedures that significantly reduced timelines of baseline processes. Oversaw technology transfer of four upstream processes to CDMOs.• Generated cell line used for the commercial production of Takhzyro® (lanadelumab-flyo).• Designed and established new upstream facilities at Burlington site.

Lawrence Township, Nj, Us

• Performed upstream process development on late-stage therapeutics and provided support in FDA review/approval. • Performed bioreactor operations at 2-L and 5-L scale.• Designed and executed scale-down bioreactor protocols for the evaluation of upstream critical process parameters used in the commercial manufacturing process of Orencia® (abatacept).• Oversaw completion of QA-approved protocols and authored Investigation Reports as needed. • Participated in the Biologic License Application (BLA) and Pre-Approval Inspection (PAI) of Orencia®.

New York, New York, Us

• Initiated and established cell line generation procedures for legacy Pfizer’s first in-house mammalian cell line development group including lab retrofit, equipment selection, and equipment purchase.• Generated NS0-GS cell lines used in the clinical programs of Figitumumab and CP-870893/Selicrelumab.• Identified biosynthetic pathways within Streptomyces for replacement of intermediate chemical steps in the semi-synthetic production of Revolution® (animal healthcare). Constructed plasmid vectors for insertional inactivation/gene replacement for strain development of production line.

B.S., Bacteriology

M.S., Food Microbiology