Jeff Caplan Email & Phone Number

Tarrytown, New York, Us

Tarrytown, New York, Us

Lead a team of managers, external manufacturing specialists and compliance specialists responsible for US commercial packaging and operations support for programs in commercial development. Relationship manager for various CMOs utilized for commercial packaging of Regeneron products. Collaborates cross functionally with managers/directors in QA, MS&T, CMC PM, DP PM, scheduling & planning and procurement to ensure strong CMO partnerships, high quality packaging and maintenance of appropriate drug stock levels.

Tarrytown, New York, Us

Tarrytown, New York, Us

In addition to the senior packaging and labeling specialist responsibilities, identify and qualify new packaging and labeling CMOs and other third party contractors. Participate in quarterly business reviews, serialization development, off-site inspections and liaise between auditing and packaging contractors. Develop and manage packaging project schedules to include clear and regular updates to upper management. Communicate with marketing, regulatory, suppliers and product development to coordinate labeling and packaging requirements for product changes and new products being commercialized.

Tarrytown, New York, Us

An integral member of the fast-paced, dynamic and cross-functional commercial external manufacturing drug supply chain team. Coordinated all aspects of commercial labeling and packaging to include Quality System compliance, batch record review and purchase requisition generation. Primarily responsible for overseeing the labeling and packaging of Eylea® (aflibercept) and Arcalyst® (rilonacept) through active management of packaging CMOs. Established strong and productive working relationships with QA, Supply Chain and operational colleagues that enabled highly efficient and continuous supply of commercial drug to market. Other responsibilities included coordinating finished goods shipments to distribution centers, cold chain management, continuous improvement, CAPA lead, change control management (process changes, new raw materials, components and specification), implementation of label and package design improvements, implementation of label and package design changes for 'Not For Sale' samples. Provide regulatory support to BLA and annual reviews. Ensure product labeling and packaging occurs in compliance with all applicable regulations. Travel extensively to contractors for overview of operations and packaging oversight. Train and lead new employee within group.

Coordinated all CMC related items pertaining to two monoclonal antibody projects in various stages of clinical development. Manage external contract manufacture organizations (CMOs) and testing organizations to ensure progress of projects and adherence to timelines. Forecasting clinical drug use and resupply needs. Lead CMC role and primary contact with CMO/CRO/packaging depot for activities such as formulation development, drug substance manufacturing, process development, purification, drug product manufacturing, placebo manufacturing, compatibility studies, stability programs, cold chain, document review, assay qualifications, technology transfer, setting release and stability specifications and verifying invoice accuracy. Contract negotiations with business development professionals at bulk drug substance and drug product CMOs, drug product packaging and storage depot, CRO and contract testing organizations. Work with internal groups such as QA, pre-clinical, clinical and regulatory colleagues to produce accurate, high quality progression of projects in clinical development. Co-author CMC sections of Investigation New Drug (IND) application. Adherence to internal quality system master plan and authored various internal SOPs in support of that plan. Created annual stability summary for tracking data across all drug product and bulk drug substance lots. Frequently travel to CMOs as the subject matter expert 'man in plant' to perform readiness evaluations, site evaluations and during manufacturing campaigns. Relied upon as the subject matter expert pertaining to all aspects of downstream purification and analytical support.

Major responsibilities included developing and implementing rapid and efficient purification processes, with an emphasis on endotoxin removal, for human monoclonal antibodies in support of therapeutic drug discovery. Excelled in the analysis of purified antibodies/process intermediates and scale up purification development. Developed additional process enhancements for the removal of aggregates, leachables and host cell proteins. Also responsible for routine human monoclonal antibody purifications, purification of recombinant target proteins, hybridoma mouse antibodies and monoclonal rat and chicken antibodies. Extensively used the AKTApurifier and AKTAexplorer for protein purifications, process development, analysis and analytical method development. Relied on for purification and analytical recommendations, purchase of the most applicable, state of the art purification instruments, analytical tools, purification reagents and resins. Developed a Protein A assay for the determination of human monoclonal antibody concentration in culture supernatant.

Raritan, Nj, Us

(Temporary Contract Employee through Kelley Scientific)Ran various tests within the Protein Assay Development team in support of validating the Vitros Fusion 5,1 FS Chemistry system. Developed comprehensive knowledge of instrument operation through routine assay programming and failure investigation. Responsible for maintaining accurate records of tests performed, instrument operation and failures. Performed data consolidation and data entry for critical reports used in support of instrument validation. Routinely given special projects to complete.

New York, New York, Us

Supervisor Phase I Production and Process Development.Coordinated and distributed projects within phase I purification development group. Worked proactively with other project leaders and department directors to determine priorities and project needs. Managed progress, performed annual performance reviews and assisted in establishing goals of two other scientists within the group. Responsibilities also included scale-up development of pre-clinical protein purification processes to phase I clinical scale, characterization of scaled-up material, GMP production of clinical material, development of stability indicating assays, accelerated/forced degradation studies, perform stability assays under GMP conditions, development of SOPs/batch records/compounding records.

New York, New York, Us

Primary responsibilities were purification process development and purification of native and recombinant bacterial proteins for discovery vaccine evaluation, isolation and solubilization of protein inclusion bodies and solubilization of proteins from bacterial membranes using differential detergent extractions. Purification of solubilized proteins using various chromatographic techniques. Additional responsibility includes characterization of purified proteins and process intermediates. Proficient in a variety of analytical tools used throughout the protein extraction, purification, and characterization process.

New York, New York, Us

Primary responsibilities were MALDI-TOF mass spectrometry analysis, amino acid sequencing using an ABI protein sequencer and analysis of peptide-protein conjugates. Developed animal experiments, prepared vaccines and analyzed immune sera in support of bacterial protein identification and peptide based vaccine research. Immunological techniques performed include peptide and whole cell ELISAs. Mass spectrometry analyses include proteins, proteinase digests of unknown 2-D gel electrophoresis spots (including database searching for protein identification), peptide-protein conjugates, glycoproteins and peptides. Train other employees.

New York, New York, Us

Responsibilities included amino acid analysis using a Beckman 6300 (method development and routine analysis), protein-peptide conjugations, and peptide purification. Utilized various techniques and specialized hydrolysis methods for cysteine, tryptophan, amino sugar, and phospho-amino acid analysis. Developed analysis method for specific peptidoglycan components. Trained on ABI peptide synthesizer.

New York, New York, Us

Primary responsibilities were amino acid analysis and protein-peptide conjugations.

Rochester, Ny, Us

Responsible for in-vitro Asparaginase toxicity analysis of bone marrow samples from acute lymphocytic leukemia patients, amino acid analysis of physiological samples from leukemia patients, and DNA/RNA preparations of leukemic cells from the same patients.