Scientist, Biologics Resume Sample
Darius Senger
96622 Grady Bypass,
Chicago,
IL
+1 (555) 183 9071
Work Experience
Principal Scientist Biologics & Vaccines Analytics
03/2018
-
PRESENT
Houston, TX
- Can provide reliable/defendable interpretations of regulatory guidances for the customer
- Training in GLP regulations and ICH guidelines
- Perform hands-on laboratory support, troubleshooting and optimization of analytical methods
- Validate and transfer analytical methods
- Support global filings, including input on license applications
- Collaborate with contract staffing on initiation, execution, and delivery of testing
- Support and lead the design and execution of method transfers to Merck global network of vaccines nodes
- Lead the design, validation and execution of analytical method transfer to Merck global network of vaccines sites and external contract research organizations (CROs) for outsourced analytical testing.
- MS in Molecular Biology, Biochemistry, Chemical Engineering or relevant life sciences discipline and 3 - 5 years related lab experience
Scientist, Biologics
08/2014
-
10/2017
San Francisco, CA
- PhD in Molecular Biology, Biochemistry, Chemical Engineering or relevant life sciences discipline and 0 – 2 yrs related lab experience
- PhD in Analytical Chemistry, Biochemistry (or relevant discipline) and 0-2 years related lab experience
- Responsible for performing laboratory tasks to support the development, optimization, and qualification/validation of chromatographic assays for biologics characterization
- Design and perform experiments for the characterization of protein therapeutics, including of monosaccharide, released N-glycan, protein glycosylation, peptide mapping, and characterization of chemical/post-translational modifications and variants
- Act as the Principal Investigator or Responsible Scientists for the scientific conduct of immunochemistry projects methods development, validation and sample analysis Train staff on laboratory procedures, documentation and GLP compliance
- Perform immunoassay techniques (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies) with proficiency Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays with proficiency
- HPLC/UPLC techniques/methods (e.g. SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc.)
- Compendial assays, (i.e appearance. pH, etc.)
- Capillary and gel electrophoresis, e.g. Western blot, SDS-PAGE, IEF, iCE, CE-SDS, Mass spectrometry (LC/MS, GC/MS, ICP/MS)
Scientist, Biologics Cell Culture Development
04/2011
-
02/2014
Phoenix, AZ
- Primary responsibilities include, but are not limited to the following: Perform analytical and biological sample testing Conduct method development and validation studies
- Perform immunoassay techniques: (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies), with proficiency
- Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays
- Maintain study documentation Meet regulatory compliance requirements
- Regular communication, oversight and collaboration with external contract research organizations (CRO) for outsourced analytical methods, to monitor timelines and deliverables
- Collaborate with contract labs on initiation, execution, and delivery of method development, validation and sample test results
- Solve technical and nontechnical challenges throughout the life of the analytical project, communicating with departmental subject matter experts as needed
- Interact closely with Procurement, Quality and Finance functions to ensure compliant outsourcing contracts are maintained and processes are standardized across the department
- Collaborate with Regulatory teams to support product registrations, launches, and troubleshooting activities, including documentation preparation, when the programs include outsourced components
Education
University of Southern California
2007 - 2011
Bachelor's Degree in Related Scientific Discipline
Professional Skills
- Proven organizational skills, good communication and problem solving ability
- Basic understanding of statistical data analysis, written and verbal communication skills
- Also required are combinations of the following skills
- Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function
- Assay validation and transfer experience
- Experience in effectively managing analytical development and testing activity at external vendors
- Basic computer skills (word processing, spreadsheets)
How to write Scientist, Biologics Resume
Scientist, Biologics role is responsible for basic, research, design, reporting, procurement, training, finance, health, excel, powerpoint.
To write great resume for scientist, biologics job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Scientist, Biologics Resume
The section contact information is important in your scientist, biologics resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Scientist, Biologics Resume
The section work experience is an essential part of your scientist, biologics resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous scientist, biologics responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular scientist, biologics position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Scientist, Biologics resume experience can include:
- In support of large molecule therapeutics, perform and/or guide method validation or transfer activities. Perform and/or guide method development activities
- Hands-on laboratory experience with LC and LC/MS methods for protein (or glycoprotein) characterization is required
- Experience with transient protein expression and purification
- Experience with assays such as ELISA and flow cytometry
- Ph.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 5+ years of relevant industry experience; or
- M.S. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 10+ years of relevant industry experience
Education on a Scientist, Biologics Resume
Make sure to make education a priority on your scientist, biologics resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your scientist, biologics experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Scientist, Biologics Resume
When listing skills on your scientist, biologics resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical scientist, biologics skills:
- Effectively collaborate with colleagues, both internal and external
- Can coordinate parallel tasks across multiple projects, demonstrating prioritization
- Experience working with automated laboratory workflows and instruments such as Hamilton and Tecan liquid handlers
- Experience working with CMO’s and CRO’s for methods transfer, method optimization, and data and report review
- Experience working in a cGMP laboratory environment in the area of vaccines and/or biologics
- Background in Analytical Chemistry or a Scientific Discipline with demonstrated analytical capabilities
List of Typical Experience For a Scientist, Biologics Resume
1
Experience For Principal Scientist Biologics & Vaccines Analytics Resume
- Perform release, stability and comparability testing of protein therapeutics
- Authorize SOPs, ELNs, study reports and regulatory filing documents and present data at cross-functional project team meetings
- Develop and execute analytical methods for physico-chemical characterization of clinical and preclinical stage protein therapeutics
- Develop and apply hydrogen deuterium exchange to probe ligand-membrane receptor interaction
- Develop quantitation methods for protein therapeutics and biomarkers from various biological matrixes
2
Experience For Senior Scientist, Biologics Resume
- Authorize posters and manuscripts to describe and disseminate new technology and applications
- Ph.D. or M.S. in Biochemistry, Chemistry, Pharmaceutical Science, or related field; corresponding with 0-3 or 5-8 years of pharmaceutical/biotech industry experience
- Hands-on experience with Waters UPLC/Empower, Orbitrap/Q-exactive and Waters Q-TOF instruments
- Experience with hydrogen deuterium exchange
- Experience with mass spectrometry based quantitation for protein therapeutics and biomarkers
- Proficiency in protein analytical methods including SDS-PAGE, western blot, CE, LC, mass spectrometry, glycan analysis, CD, ELISA, SPR and fluorescence methods
- Advanced knowledge about protein chemistry, protein therapeutics discovery and development process
List of Typical Skills For a Scientist, Biologics Resume
1
Skills For Principal Scientist Biologics & Vaccines Analytics Resume
- Performing N-terminal sequencing if available
- Lab instrument maintenance – cleaning spray sources and calibration weekly, prepping calibration solutions
- Quickly adapt to a rapidly changing environment and demands
- Kinetic binding assessment (e.g. BLI or SPR)
- Support drug substance process development including characterization of in-process and formulated drug substance and drug product
- An understanding of fundamental biopharmaceutical principles for the development of injectable drug products of biologic drug candidates
- Project management and project forecasting
- Support strategic initiatives within departmental and cross-functional teams representing BVA
- Support strategic initiatives within departmental and cross-functional teams representing Biologics, Vaccine Analytics (BVA)
2
Skills For Senior Scientist, Biologics Resume
- Setup evaluation strategy using cell-based assays, biochemical and biophysical analysis to identify lead candidates of novel therapies
- Ph.D. or M.S. in Protein science, antibody engineering, Immunology or related field
- Intact mass analysis using mass spectrometry (HPLC-Q-TOF MS)
- Data analysis, Documentation, and reporting – ELNs, etc.,
- MS Lab specific supply maintenance – inventory and ordering
- Monitor performance and report timeline updates, pricing adjustments or overall project changes
- Ensure project results meet requirements regarding technical quality, reliability, schedule and cost
- Metals testing, ICP-OES, ICP-MS, AA (for small and large molecules)
3
Skills For Scientist, Biologics Analytical Development Resume
- Compendial testing (e.g. viscosity, Osmolarity, osmolality, HIAC, etc.)
- Particle size testing
- Self motivated and independently minded
- Self-organizer, meticulous hands-on habits, keen attention to detail
- In vitro cell based assays (e.g. reporter gene bioassay, cell titer glo proliferation bioassay, etc.)
- Molecular biology (e.g. qPCR, PCR, etc.)
4
Skills For Associate Scientist, Biologics Resume
- Other technologies/methodologies as required by management
- This Scientist is responsible for the characterization of protein primary structure, carbohydrate structure of biologics using mass spectrometry based techniques
- Develop, optimize and qualify analytical methods for structural characterization of biologics
- Maintain lab notebooks in a compliant manner, draft study protocols, reports and SOPs for inclusion in regulatory filings
- Ensure that all facilities, equipment, and personnel are compliant with applicable regulatory requirements, appropriate SOPs and corporate policies
- Work independently and in cross functional team environment
- 19 days of paid time off annually
5
Skills For Senior Scientist Biologics & Vaccines Analytics Resume
- Be highly motivated, independent and interactive
- Knowledge of cGLP/cGMP, FDA, EMA, ICH guidance’s and industry standards for analytical development and characterization of proteins
- Knowledge of cGLP/cGMP, FDA, EMA, ICH guidance’s and industry standards for Quality by Design (QbD) and lifecycle approaches
- Recognize unmet customer needs
- Compendia assays, (i.e. appearance. pH, etc.)
- Monitor purchase orders and invoices for outsourced programs
- Initiate stakeholder feedback for CRO projects, update scorecards and complete after-action reviews
- In support of large molecule therapeutics, develop and execute laboratory work plans/schedules for self and junior members of team, using customer milestones and Division/site performance standards and metrics
- Sample types include in-process, release or stability
6
Skills For Scientist, Biologics Cell Culture Development Resume
- Management of comparability studies and analytical technology transfers
- Review of the systems and/or capabilities of analytical contract suppliers to assess alignment with compliance and need
- Review of protocols and reports from analytical contract suppliers
- Work with Procurement to manage and contract with critical reagent and critical supply vendors
- Draft critical reagent qualification strategies
7
Skills For Associate Scientist Biologics & Vaccines Analytics Resume
- Apply expertise in antibody discovery and protein characterization to lead and influence projects within the development of Precigen’s product portfolio
- QC analysis for non-multispecific panels (mAbs, Fabs, scfv)
- HTP panel analysis for non-multispecific panels (mAbs, Fabs, scfv)
- Intact mass panels for stress studies of non-multispecific molecules
- Check HPLC buffers daily and replenish as needed
- General lab solutions: Buffers for enzymatic digestions and assays etc
- Responsive, can-do attitude
8
Skills For Senior Scientist Biologics Characterization Resume
- UV-Vis, Solo-VPE, Nano Drop
- HPLC/UPLC techniques/methods (e.g. SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc.) Karl Fischer,Compendia assays, (i.e. appearance. pH, etc.) UV-Vis, Solo-VPE, Nano Drop
- Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs. Review technical documents for accuracy, thoroughness and regulatory compliance & author technical documents, such as protocols, test methods, reports, certificates of analysis, and operating procedures
- Capability to manage individual components of a project and prioritize well
- Experience with or exposure to one or more of the following analytical techniques: Bioassay, Viral Infectivity assays (plaque/TCID50/others), Plaque assay, ELISA methods, PCR/RT-PCR, Sequencing, Separations methods (e.g. HPLC/UPLC), CE
9
Skills For Scientist Biologics & Vaccines Analytics Resume
- Experience working with contract research organizations and/or procurement teams
- Experience with continuous improvement or Project Management Professional certification
- Work independently and work within a cross-functional team
- Track analytical budget line items
- Manage analytical transfers to or from CRO facilities
- Draft analytical SOP updates
10
Skills For Scientist, Biologics Product Development Resume
- Chemical inventory for EHS
- Capillary and gel electrophoresis (e.g. CE-SDS, SDS-PAGE, icIEF, IEF, western blott, etc.)
- Mass spectrometry (e.g. LCMS, GCMS, ICP-MS, for small and large molecules)
- FTIR, NIR, Polarimetry (for small and large molecules as appropriate)
- CD, Intrinsic fluorescence, DSC, TGA
- E-tongue (for small and large molecules as appropriate)
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