Scientist, Biologics Resume Samples

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A McGlynn

Albert

McGlynn

2485 Daniel Underpass

Chicago

+1 (555) 681 9025

2485 Daniel Underpass

Chicago

Phone

p +1 (555) 681 9025

Experience Experience

Chicago, IL

Scientist, Biologics

Chicago, IL

Heidenreich LLC

Chicago, IL

Scientist, Biologics

Supervises technical staff, including work assignments and performance management
In support of large molecule therapeutics, perform method validation or transfer activities. Under direction, perform method development activities
Under direction, perform method development activities
Executes efficiency improvement project with guidance
In support of large molecule therapeutics, perform method validation or transfer activities
Authors technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures
Responsible as Project Technical Lead with responsibility for project outcome and customer interaction

Boston, MA

Senior Scientist, Biologics

Boston, MA

Ortiz, Mayer and Runte

Boston, MA

Senior Scientist, Biologics

Supervises technical staff, including work assignments and performance and development management
Data review - To perform checking & verifying of peers analytical data in accordance with in-house SOPs
Drives improvement projects at the department level. Identifies opportunities for improvement projects
Support development of business strategies across the business units
Trains, coaches or mentors others on technical, personal development or business issues
Recommends and assists in implementation of new technologies and understands their impact on Catalent offerings
Excellent motivator, well versed in team development

present

Chicago, IL

Principal Scientist Biologics & Vaccines Analytics

Chicago, IL

Stiedemann-Miller

present

Chicago, IL

Principal Scientist Biologics & Vaccines Analytics

present

Interface across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of vaccine analytics
Coordinate with multiple analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and transfers between Merck, external partners and CMO/CROs
Lead cross functional teams and ensure alignment of analytical strategies with Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes
Provide technical and strategic oversight to the development and optimization of molecular/cellular biology-based, cell-based, microbiological, immunochemistry, separation, all relevant analytical methods and preparation and execution of method transfers and validations
Provide on-going support to internal and external partners to resolve analytical issues and trouble-shooting
Assist with the technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods
Contribute as author and reviewer to regulatory submissions including marketing applications

Education Education

Bachelor’s Degree in Biology

Syracuse University

Bachelor’s Degree in Biology

Skills Skills

Knowledge of cGMP knowledge is desirable
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
Develop and execute complex procedures or methods with high quality
Excellent written and verbal communications skills with internal and external customers
Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
Well organized with ability to multitask
Ability to mentor/train peers as necessary
Ability to multitask
Ability to be flexible
Ability to work effectively under pressure to meet deadlines

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15 Scientist, Biologics resume templates

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Associate Scientist, Biologics Resume Examples & Samples

Principal Technical Responsibilities may include
Experience with cGMP
Data review - To perform checking & verifying of peers analytical data in accordance with in-house SOPs
Capillary and gel electrophoresis, e.g. Western blot, SDS-PAGE, IEF, iCE, CE-SDS
Familiar with compendia methods/testing and impurities testing
Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
May require the use of a respirator

Senior Scientist, Biologics Resume Examples & Samples

Develop and execute laboratory workplans/schedules for self and junior members of team, using customer milestones and Division/site performance standards and metrics
Supervises technical staff, including work assignments and performance and development management
Drives improvement projects at the department level. Identifies opportunities for improvement projects
Support development of business strategies across the business units
HPLC, UPLC, peptide mapping, size exclusion HPLC, ion-exchange HPLC, oligosaccharide/glycan analysis, sialic acids, monosaccharides
Chromatography Data Systems (e.g. Empower, OpenLab)
Protein chemistry
Familiar with compendial methods/testing and impurities testing
Capable of method development, method validation and troubleshooting
Actual position will be commensurate with experience
Well organized with ability to handle multiple activities simultaneously
Ability to communicate moderately complex technical information to non-technical audiences
Leadership development/ supervisory skills are expected
Recommends and assists in implementation of new technologies and understands their impact on Catalent offerings
High personal credibility with peers and subordinates
Can assess training needs and formulate development plans for direct reports

Senior Scientist, Biologics Services Resume Examples & Samples

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
Maintain interaction with external clients and industry professionals

Scientist, Biologics Services Resume Examples & Samples

Perform biologics method transfer, method development, method validation, and sample analysis according to FDA guidance, Frontage SOP and industry practice
Perform immunoassay techniques (ELISA, MSD or other ligand binding based assays, 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
Perform RNA, DNA isolation, PCR and qPCR assays
Maintenance of instruments, and address technical and instrumental issues
Assist the Principal Investigator with study conduct
Meet regulatory compliance requirements

Senior Scientist, Biologics Resume Examples & Samples

Provide technical expertise and experience and serve as a resource to the organization
Designing, planning and overseeing the conduction of pharmacology, safety pharmacology, toxicology and complicated mechanistic toxicology studies designed to address specific regulatory issues
Assisting in the selection, auditing and approval of contract testing facilities used for such studies, ensuring data quality and integrity from monitored preclinical sites
The preferred candidate will have a PhD with 2 years of experience in pharmaceutical laboratory or a minimum of 4 years with a Master’s degree or 9 years with a Bachelor degree. However, combination of experience and/or education will be taken into consideration
Must possess knowledge of biologic and chemical analytical characterization including but not limited to HPLC, MS, LC-MS, MALDI-MS, AA sequencing, NMR, XRD, CD, FACS, immunogenicity, receptor binding and cell based assays
Must possess knowledge of the biological impact of drug materials in the human body and application of GLP and ISO regulations is required. Knowledge of applicable world health authorities’ regulations, standards and guidelines covering biological and biosimilar drug development is essential
Position functions semi-autonomously. Position directly supervises employees.Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization

Senior Scientist, Biologics Generation Group Resume Examples & Samples

Develop advanced analytical methods to characterize biologics using mass spectrometry and UHPLC
Design and execute assays for high throughput drug-like property assessment of biologics
Impact projects through protein production and screening of recombinant biopharmaceutical candidates in high throughput
Demonstrate scientific excellence, work ethic, and dedication to team and project goals
Work collaboratively in a matrix with project teams and members of the Biologics Generation Group to drive innovation and deliver novel therapies to our patients
Bachelor’s degree in related discipline with 7 or more years of experience or Master’s degree with 5 or more years of experience
Expertise in protein analytical techniques for the assessment of drug-like properties of biopharmaceutical candidates
Experience maintaining instrumentation and method development for protein and peptide mass spectrometry
PhD in related discipline with no experience necessary

Senior Scientist Biologics Characterization Resume Examples & Samples

Have strong hands-on experience with UPLC and high resolution mass spectrometry applied to Large Molecules characterization
Demonstrated Experience in HDX-MS required
Demonstrated experience with de novo protein sequencing (manual and software-assisted data interpretation) required
Experience in developing new assays, out-of-the-box and creative thinking
Industry cGMP experience required
Be highly organized and capable of multitasking to meet required deadlines
Have ability to focus on critical tasks, give proper attention to detail

Scientist Biologics & Vaccines Analytics Resume Examples & Samples

Drive continuous improvement through laboratory standardization, lean laboratory, and six sigma methodology
Support various vaccine registrations, launches, and troubleshooting activities external to the US, including documentation preparation
Coordinate global reagent and sample submissions
Minimum of two (2) years of experience working in a cGMP laboratory environment in the area of vaccines
Ability to learn new techniques and multitask
Good technical, communication (oral and written), interpersonal, and teamwork skills
Self-motivated with a positive attitude and proven performance record

Principal Scientist Biologics & Vaccines Analytics Resume Examples & Samples

Lead a scientific team in the design and execution of method transfers to Merck global network of vaccines nodes. Participate locally as required
Coordinate with multiple analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and transfers between Merck, external partners and CMO/CROs
Lead cross functional teams and ensure alignment of analytical strategies with Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes
Provide technical and strategic oversight to the development and optimization of molecular/cellular biology-based, cell-based, microbiological, immunochemistry, separation, all relevant analytical methods and preparation and execution of method transfers and validations
Assist with the technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods
Coordinate analytical issue resolution as needed via subject matter experts within the global vaccines network
Contribute as author and reviewer to regulatory submissions including marketing applications
Travel as required up to 25%
Experience in the fields of molecular/cellular biology and biochemistry, including knowledge of several of the following techniques

Senior Scientist Biologics & Vaccines Analytics Resume Examples & Samples

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
Author regulatory submissions to support for global filings, including license application
Coordinate with cross-functional teams to support process development efforts, including overseeing analytical work and contributing to data interpretation (as required)
Interface with internal and external partners, international governments, and/or contract manufacturing or testing organizations for vaccine analytics
Utilize continuous improvement for laboratory standardization, Lean laboratory, and Six Sigma methodology
Support Vaccine Assay Life Cycle activities across various vaccine franchises and analytical platforms
Support vaccine registrations, launches, and troubleshooting activities external to the US, including documentation preparation
Travel, as required (up to 25%)
Experience in analytical development and validation, and quality control (QC) with working knowledge of current Good Manufacturing Practices (cGMP)
Minimum of two (2) years in cGMP laboratory
Ability to work independently and within a cross-functional team
Experience with mammalian cell culture, cell-based assays, and/or vaccine research, including at least one of the following techniques

Associate Scientist Biologics & Vaccines Analytics Resume Examples & Samples

Direct interaction (Oversight and collaboration) with external contract research organizations for outsourced analytical methods
Function as a key team member to validate and transfer analytical methods
Support analytical compliance and Quality for investigations and corrective actions
Support strategic initiatives within departmental and cross-functional teams representing GVBC-BVA
Function as a key member to support and lead the design and execution of method transfers to Merck global network of vaccine nodes
Travel, as required (up to 10%)
Experience working in a cGMP laboratory environment in the area of vaccines
Capability to manage individual components of a project
Experience with at least one of the following techniques

Scientist, Biologics Resume Examples & Samples

Experience in some or all of the following
Experience with at least one of the following
Gel electrophoresis (SDS-PAGE and IEF)
Capillary electrophoresis (CE-SDS and iCE)
Metals testing by ICP/MS, ICP/OES, AAA
Mass spectrometry (LC and GC)
Compendia testing such as HIAC, Osmolality, container closure
FTIR and CD
Development and/or optimization
Knowledge of cGMP knowledge is desirable
Capillary electrophoresis
Ability to execute projects on timely basis

Senior Scientist, Biologics Resume Examples & Samples

ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD)
Good project management/coordination skills; Scientific background in GMP analytical and/or business background desirable; experience with S&OP; Good organizational skills; Significant experience with excel and powerpoint
Actual position will be commiserate with experience

Scientist, Biologics Analytical Development Resume Examples & Samples

Responsible for performing laboratory tasks to support the development, optimization, and qualification/validation of chromatographic and mass spectrometry assays for biologics characterization
Design and perform experiments for the characterization of protein therapeutics, including of monosaccharide, released N-glycan, intact molecular weight, peptide mapping, protein glycosylation and characterization of chemical/post-translational modifications and variants
Design and perform experiments for the qualification/validation of analytical methods and their transfer to quality control and contact laboratories
Support therapeutic protein drug substance process development and validation
Support therapeutic protein drug product formulation, evaluation of prototypes, process development, and validation
Serve on departmental, interdepartmental, and project teams
Write and review formal reports, including method SOPs, reports, and other technical documents
Maintain documentation of all work in laboratory notebooks
Comprehensive hands-on knowledge of protein analytics and characterization
Extensive laboratory experience with techniques such as HPLC (RP, SEC, IEC), HPAEC-PAD, LC-MS and LC-MS/MS, released glycan assays, and CE
Experience in sample preparation techniques including proteolytic digestion, deglycosylation, reduction, alkylation, desalting, buffer exchange, fluorescent labeling
Experience in the operation, maintenance, and troubleshooting of LC, LC-MS, HPAEC-PAD, and CE instrumentation
Problem-solving and troubleshooting skills
Laboratory experience with and knowledge of protein biochemical and biophysical techniques such as enzyme activity assays, receptor binding assays, cell based bioassays, ELISA, Western blot, qPCR, iCEF, CD, DSC, DLS
Knowledge of cGLP/cGMP, FDA, EMA, ICH guidance’s and industry standards for analytical development and characterization of proteins
Skills in DOE, QbD

Scientist, Biologics Cell Culture Development Resume Examples & Samples

Responsible for performing laboratory tasks to support the development, optimization, and scale-up of mammalian cell culture process
Design and perform experiments to study cell culture process parameters and their impact on process performance and product attributes
Evaluate data for trends indicative of process and product attributes
Operation, maintenance, and installation of equipment
Write and review formal reports, including SOPs, reports, and other technical documents
Adhere to all relevant compliance regulations
Comprehensive hands-on knowledge of mammalian cell culture processes
Extensive laboratory experience with sterile techniques, shake-flask studies, stirred tank bioreactors and scale-up understanding
Laboratory experience with and knowledge of cell line development
Knowledge of cGLP/cGMP, FDA, EMA, ICH guidance’s and industry standards for Quality by Design (QbD) and lifecycle approaches
Skills in statistics and statistical analyses of data

Scientist, Biologics Resume Examples & Samples

In support of large molecule therapeutics, develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics. Sample types include in-process, release or stability. Techniques may include any or all of the following
HPLC/UPLC techniques/methods (e.g SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc)
Karl Fischer,
Compendial assays, (i.e appearance. pH, etc)
UV-Vis
Aggregation techniques such as MFI, AUC, SEC-MALS
In support of large molecule therapeutics, perform method validation or transfer activities
Under direction, perform method development activities
Perform activities under cGMP as appropriate
Identify and recommend business opportunities on a project specific basis
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs

Scientist, Biologics Product Development Resume Examples & Samples

Ph.D. in Biochemistry, Molecular Biology, Pharmaceutics, Pharmaceutical Chemistry, Bioengineering or a related discipline with 0-2 years of relevant laboratory experience
A thorough understanding of protein structure, chemistry and stability attributes
Hands-on experience with bioanalytical instrumentation, such as SEC, SDS-PAGE, IEF/cIEF, spectroscopy and calorimetry
Experience with biophysical characterization, thermodynamics and mechanistic understanding of protein degradation, protein-protein, and protein-excipient interactions
An ability to effectively and collaboratively participate in team discussions

Scientist, Biologics Generation Group Resume Examples & Samples

Responsibility for protein production and characterization of biopharmaceutical products such as monoclonal antibodies and novel multi-specifics
The ideal candidate will have direct experience with mammalian cell culture, molecular biology, and assays such as ELISA and flow cytometry
Bachelor’s degree in related discipline with 5 or more years of experience or Master’s degree with 2 or more years of experience
Other helpful skills include the production of antibodies in transient cell culture, protein purification, protein characterization methods such as SEC and Mass Spec, and experience with automation equipment
Attention to detail and excellent record keeping skills are required

Principal Scientist Biologics & Vaccines Analytics Resume Examples & Samples

Develop and direct execution of analytical strategies associated with method development, validation, transfer, and life-cycle management to support recombinant vaccines
Manage and lead a growing team of scientists tasked with providing analytical support to vaccine candidates in late-stage development as well as to in-line vaccines
Interface across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMOs/CROs) in the area of vaccine analytics
Coordinate with analytical and process development groups to prepare for and execute validation and technology transfers between Merck, external partners, and CMO/CROs
Provide timely and effective trouble-shooting of analytical issues encountered within the Merck network as well as in external partner, government, and CMO/CRO laboratories
Lead cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (e.g., Phase III clinical trials, launch preparation) for novel vaccines
Lead preparation and execution of analytical method validations and transfers, including authoring, approving, and coordinating review of protocols and reports
Coordinate analytical issue resolution via subject matter experts within the global vaccines network
Contribute as author and reviewer to regulatory submissions, including marketing applications
Travel as required up to 20%
At least 5 years working experience in the area of vaccine analytics in an industry setting
At least 3 years working experience in a GMP setting
Experience developing, validating, and transferring immunological/immunochemical, chromatography-based, and/or cell-based analytical methods
Experience leading late-stage and/or in-line vaccine method development, validation, and transfer activities
Demonstrated track record of success with trouble-shooting analytical issues—including those encountered in remote/international laboratories
Experience leading cross-functional teams that support late-stage vaccine commercialization and marketed products
Experience directing the laboratory activities of other analytical scientists
Experience with vaccine drug substance and drug product specification setting and with release, stability, and extended characterization testing
Experience with CMC document preparation, including authoring and review
Experience in interactions with US and Ex-US regulatory authorities
Ability to effectively identify and communicate risks
Experience with analytical change control processes

Scientist Biologics Discovery Resume Examples & Samples

You take the responsibility for several research projects to make sure that tasks are practically conducted and milestones met according to project plans and goals. This includes the documentation and presentation of results as well as writing of patent applications and scientific manuscripts
This comprises the development of cell-biological assays on the basis of scientific literature research as well as in-house expertise
You ensure that new technologies in drug discovery are evaluated, adapted or developed in line with business needs
Besides, you take care that safety and environmental guidelines and regulations are followed including corresponding documentation
We ask you to support an efficient teamwork by fostering good communication with group and project team members as well as supervisors and collaborators
The contribution to new project proposals by literature and database searches as well as scientific discussions with in-house and external experts also belongs to your tasks

Associate Scientist, Biologics Resume Examples & Samples

Ability to lift up to 44 pounds and stand on feet for extended periods of time
Members of staff within Biologics
Cell Biology, Immunochemistry, Molecular Biology is desirable

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