Scientific Manager Resume Sample

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Work Experience


Scientific Manager
04/2017 - PRESENT
Detroit, MI
  • Reviews, evaluates, interprets, and integrates medical records, patient data, patient specimens, and/or test results and provides correlation with the different laboratory analyses, including but not limited to flow cytometry, molecular pathology, Nanostring technology, murine/pre-clinical studies, etc.
  • Utilize various computer systems and databases to enter, retrieve and compile data, complete patient/product laboratory records and prepare reports for review by laboratory directors, quality assurance and physicians
  • Manages Facilities Asset Request (FAR) renovations, equipment purchasing, and asset inventory
  • Directs the effective operation of translational research projects as required
  • Manages clinical research activities to meet Good Manufacturing Practices (GMP) guidelines/standards. Maintains working knowledge of GMP guidelines
  • Establish and maintain research collaborations with biotech and pharmaceutical firms in correlation with Clinical Laboratory Projects
  • Leads research initiatives and provides oversight of the veto cells program
Scientific Affairs Manager
05/2011 - 11/2016
San Francisco, CA
  • Leads in research activities developing new and innovative techniques working with large numbers of materials and data, developing and implementing support systems to document research results
  • Actively prepares and submits for presentation and peer-reviewed publication abstracts and manuscripts related to research outcomes
  • Maintain the Regulatory, cGMP / GCP compliance and efficiencies of all areas of accountability
  • Be recognised as the RB stability expert providing global consultation in this role
  • Oversee the successful transfer of teams, facilities and processes to the new Centre for Scientific Excellence in Hull
  • Manage and develop a team of 3 direct reports and a wider group of around 17 colleagues
  • Provide periodic information and recommendations to the Department Chair(s) regarding the development, evaluation, and revision of policies and procedures for the prioritization of moon shot research activities
Senior Scientific Affairs Manager
09/2008 - 11/2010
Detroit, MI
  • Provide advice and resource information for long-term strategic planning of moon shot research initiatives, including options, directions, funding sources, and feasibility
  • Act as a resource for faculty to identify opportunities for new moon shot research initiatives, including those that involve collaborations within M. D. Anderson and extramurally
  • Review, interpret, summarize, and provide guidance & recommendations on technical matters including independent research studies and supplier data
  • Design and execute research studies with GPN products
  • Write and edit articles, press releases, white papers, and other technical pieces for industry publications and company sales & marketing materials
  • Keep abreast of emerging science and policies in the nutrition environment and identify nutrition-related business opportunities globally
  • Develop and deliver product-specific messaging for targeted customer audiences and nutrition focused organizations
  • Develop and provide nutrition education and training for internal audiences
  • Assist counsel in researching/responding to legal matters, as needed

Education


University of Maine at Machias
2003 - 2007
Master's Degree in Biology

Professional Skills


  • Communication – ability to expresses one’s self clearly and concisely to key stakeholders and functional management; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience
  • Excellent skills working with experts from other functions and countries and influencing decision making without authority in a matrix environment
  • Excellent computer skills involving databases, spreadsheets and slide presentations
  • Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions
  • Excellent communications and presentation skills – written and verbal; create and deliver presentations with appropriate messaging and focused recommendations
  • Experience with the application of project management knowledge, skills, tools, and techniques for complex multidisciplinary programs
  • Multi-task, strong interpersonal skills and results oriented

How to write Scientific Manager Resume

Scientific Manager role is responsible for interpersonal, languages, government, training, database, purchasing, payroll, oncology, design, research.
To write great resume for scientific manager job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Scientific Manager Resume

The section contact information is important in your scientific manager 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
  • Email
  • Telephone number

Work Experience in Your Scientific Manager Resume

The section work experience is an essential part of your scientific manager 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 scientific manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular scientific manager position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Scientific Manager resume experience can include:

  • Excellent oral and written communication skills including presentation, lecture, and teaching skills
  • Excellent problem solving, written and organizational skills with the ability to manage complex scientific information
  • Create clinical strategies that support our ambition of strong clinical evidence on innovative products for regulatory and marketing purposes
  • Effectively communicate across technical and non-technical audiences internally and externally
  • Expertise and experience in genome editing tools including CRISPR/Cas9
  • Experience: public speaking and technical writing

Education on a Scientific Manager Resume

Make sure to make education a priority on your scientific manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your scientific manager 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 Scientific Manager Resume

When listing skills on your scientific manager 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 scientific manager skills:

  • Leadership– develops and uses knowledge and interpersonal skills to influence and guide stakeholders towards the accomplishment of program and divisional goals and objectives; adapts well to different personalities and manages others on the team in a respectful manner
  • Strong interpersonal skills, organisational skills, teamwork and collaboration skills
  • English writing skills equivalent to those of a native speaker
  • Operate as an effective tactical, as well as strategic, thinker
  • Relevant experience in cell and gene therapies CMC teams including experience on product development teams
  • Proven track record and demonstrated success in process development and/or clinical manufacturing

List of Typical Experience For a Scientific Manager Resume

1

Experience For Scientific Affairs Manager Resume

  • Demonstrated ability to prioritize multiple assignments, deliver activities and results with excellent attention to detail
  • Proven and demonstrated ability to understand process and disseminate complex scientific material to key personnel in presentations and discussions
  • Experience in medical writing for the pharmaceutical industry to include writing of clinical trial results
  • Experience in managing many individual projects simultaneously
  • Experience in leading a team through completion of a project
  • Proven track record establishing and maintaining scientific collaborative relationships with key opinion and though leaders
  • Cultivate and establish strong collaborative relationships with key opinion and thought leaders
2

Experience For Senior Scientific Manager Resume

  • Or more of industrial experience including in an In Vitro Diagnostic environment, preferably in scientific affairs or marketing
  • Expertise in autoimmune or infectious disease and / or medical fields with strong Diagnostics focus
  • Strong proficiency with MS Word, Excel, Power Point, and internet databases
  • Work in a fast-paced environment meet deadlines and prioritize work on multiple projects
  • Assertive and proactive with excellent follow through
  • Educates and demonstrates the benefits of key products to scientific and clinical customers
  • Working with department heads, commercial, and legal to finalize proposals with pricing
  • Developing and fine tuning producer cell lines for gene therapy vectors
  • Generating project proposals, data summaries, and experimental reports
3

Experience For Senior Scientific Affairs Manager Resume

  • Drive enhancement of internal and external reputation by identifying, interpreting, and influencing the emerging scientific environment
  • Accountable project execution, hiring, training, staff assignment, coaching, mentoring and performance management
  • Thorough understanding of package inserts, marketing materials and related corporate documents to ensure adherence to FDA and corporate compliance guidelines
  • Academic or Clinical background in clinical diagnostic testing; molecular diagnostics, sequencing technology, oncology and/or infectious disease
  • Liaison to Global Marketing and Regional commercial teams- assist in development and implementation of scientific marketing and sales tools
4

Experience For Manager, Scientific Affairs Resume

  • Plays a critical role in establishing Royal Canin as a scientific thought leader in the animal health industry
  • Monitor productivity and ensure metrics are being met, which include delivery, quality and customer communications
  • Determine need, and aid in the design and messaging of resources to support the molecular diagnostics market segment
  • Bispecific discovery projects, including design and optimization; and
  • Large FTE projects that involve multiple business units (not including the development center) across the company
  • Provide clinical and product training to KOLs and academic centers
  • Multi-target antibody discovery and antibody engineering projects
  • Accountable for specific project elements as assigned in analytical development for product testing and characterization
  • Responsible for managing expenses within budget
5

Experience For Global Scientific Manager Cardiology Resume

  • Proficient in Word, Excel, and MS Office programs
  • Provides technical expertise and support to BRM functions in order to realize customer requests and sample strategies
  • Represents BRM, as needed, in disease area and functional area meetings for PD, gRED, pRED and Diagnostics
  • Knowledge of and compliance with laws and regulations, policies and procedures, guidelines for data dissemination and interactions with health care professionals
  • Familiar with Roche Diagnostics products
  • Act as the scientific voice of Royal Canin
  • Manage all aspects of Scientific Services, including Technical Lab Services, Lab Support Coordination, Materials Management, Chemical Stores, and Media Preparation
  • Assure all applicable employees have been trained on applicable procedures as well as safety and all client/Sodexo required training
6

Experience For Scientific Services Manager Resume

  • Act as a back-up for oversight and administration for Laboratory Services
  • Responsible for payroll oversight and human resource issues
  • Assist in compliance related activities including: audits, training records, good documentation practices, SOPs, Forms and Work Instructions at a single site of operations
  • Develop and revise existing standards governing the scientific services operations as driven by needs to support the operation
  • Work with local Compliance team to ensure migration of changes and enhancements of processes and procedures
  • Conduct activities in a professional manner appropriate for a laboratory environment
  • Review employee attendance on a monthly basis with site Lead(s) and address attendance issues
  • Perform periodic and annual review of employees
7

Experience For Senior Manager European Scientific Publications Resume

  • Oversee work orders and follow up on repairs and maintenance issues as needed
  • Provide technical assistance to staff for lab related issues
  • Liaise with third party contractors who perform activities managed by Sodexo as needed
  • Act as primary point of contact for client in regards to above mentioned Scientific Services. Follow company, departmental and local safety policies and procedures
  • Educate internal Bio-Rad staff regarding key aspects of new and revised laboratory and clinical practice standards pertaining to molecular diagnostics
  • Propose and implement improvements and innovations to the Scientific Services processes
  • Conduct effective clinical and scientific presentations to help drive Bio-Rad’s scientific leadership through research, conference symposia, publications, and educational activities
  • Facilitate collaborative relationships with thought leaders, with a goal of building advocates, advisors, expert guest speakers, and business development partners
8

Experience For Scientific Manager, Immunology Resume

  • Influence clinical guideline development to ensure maximum exposure and uptake for Bio-Rad’s molecular diagnostic portfolio
  • Provide scientific, technical, and medical expertise and guidance to the Americas Commercial organization, and relevant divisional business partners within Bio-Rad
  • Track industry trends and developments in the area of oncology precision medicine and related biomarkers
  • Obtain and communicate intelligence related to the development, regulatory approval and commercialization of companion and complementary oncology biomarker assays
  • Maintain high standard proficiencies with medical best practices, therapeutic guidelines, and scientific literature pertaining to Bio-Rad’s portfolio and technology
  • Assist in writing and reviewing of white papers, abstracts, and manuscripts for peer-review publication. Contribute to the review of Bio-Rad sponsored and Investigator sponsored studies
  • History of presenting scientific data at conferences, symposiums and society meetings as well as record of publications in peer-reviewed journals
9

Experience For Manager of Scientific Affairs Resume

  • Comfortable using multiple media outlets to engage a team or customers via webinars, conference calls or video conferences
  • 40-50% overnight travel required depending on residence location
  • Maintain expert working knowledge of the autoimmune and infectious disease fields and the technologies and the services provided by CID
  • Deliver technical and product presentations on behalf of the company and industry partners at seminars, conferences, workshops and training events
  • Consistent track record of high-level achievement in research and business areas with the ability to interact with personnel at all levels and departments
  • Able to communicate technical concepts both verbally and written with clarity and accuracy
10

Experience For Bioanalytical Scientific Manager Resume

  • Proficient use of Microsoft applications, ie. Powerpoint, Word and Excel
  • PhD, MD, PharmD or DO is required
  • Drive CID scientific leadership through research, congress symposia, publications, and educational activities
  • Influence clinical guideline development to ensure maximum exposure/uptake for CID products and technologies worldwide
  • Provide scientific, technical and medical expertise and guidance to the division and according functions including Commercial Operations, Global Marketing, Regulatory Affairs, and Quality – for support activities of existing product offerings and identification of new products and their respective development
  • Maintain an expert scientific and clinical knowledge relevant to autoimmune and infectious disease
  • Monitor industry developments to assess competitive activity and identify opportunities for future business opportunities
  • Contribute to the review of Bio-Rad-sponsored and Investigator-sponsored studies
  • To educate internal Bio-Rad staff regarding key aspects of new and revised laboratory and clinical practice standards in order to promote the CID group products

List of Typical Skills For a Scientific Manager Resume

1

Skills For Scientific Affairs Manager Resume

  • Demonstrated strong communication skills, interpersonal skills, and a superior drive for
  • Excellent written, oral, interpersonal and presentation skills and the ability to effectively
  • Excellent computer skills, experience with shell scripting or Spotfire or R
  • Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously
  • Excellent oral, written and interpersonal skills, especially with colleagues and external customers
  • Communicates effectively with experts, dermal professional organizations and academia as needed on current dermal science, technology and research
  • Proven track record and demonstrated success in analytical development
  • Solid experience with conducting in vitro assays
2

Skills For Senior Scientific Manager Resume

  • Demonstrated managerial and organizational skill
  • Superb organizational and communications—both written and oral skills and “do-what-it-takes” attitude
  • Knowledge of current pharmaceutical technologies, including formulation of advanced and standard solid dosage forms, liquid and parenteral dosage forms
  • Experience working in a matrix organization in multinational companies would be advantage
  • Experience in innovator or generic or biologic pharmaceutical products, packaging systems, combination products, devices
  • In-depth understanding of and proven success in how to develop sound clinical trials
  • Experience with flow cytometry including FACS are highly desirable
3

Skills For Senior Scientific Affairs Manager Resume

  • Good Understanding of the UK/Ireland Regulatory Environment
  • Experience in and detailed understanding of the publication process
  • Experience in the pharma or CRO industry supporting regulatory bioanalysis of large molecules
  • Previous experience managing contract research organisations
  • Prepare evidence-based argumentation for price discussions in collaboration with Market Access/Marketing
  • Experience working with business leaders, clinicians, and regulatory authorities
  • 5 – 8 years’ experience is required
4

Skills For Manager, Scientific Affairs Resume

  • Validate molecular structures and purity of reagents, intermediates and final products
  • Maximize utility of available budgets, operate within relevant budgets, and ensure expenses are accounted for in line with company policies and procedures
  • Experience with clinical study design and execution and statistical methodology
  • Experience with preparation of clinical evaluations of medical devices
  • Experience within publication of clinical outcomes
  • Experience in ismilar roles
  • Over 5 years relevant experience in molecular diagnostics
5

Skills For Global Scientific Manager Cardiology Resume

  • Experience in product development or support
  • Reviewing and approving medical and scientific content of North American Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial
  • Collaborating proactively with members of other functional groups is critical
  • Understanding of safe lab practices and BSL requirements is important
  • Leading NAMA activities for Prostate Cancer
  • Coordinating activities across multiple sites and third-party vendors
  • A broad understanding of packaging & delivery systems, analytical testing and data correlation related to the pharmaceutical market
6

Skills For Scientific Services Manager Resume

  • Excellence in solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
  • Is accountable for managing BRM generated genetic array data, performing data analyses and acting on outcomes
  • Assist PI in monitoring expenditures and updating financial projections for research on long end-associative polymers
  • Analyze feasibility of the process at scale considering factors ranging from safety to stability of feedstocks
  • Act as a liaison between customers and Sodexo services, applying problem solving and investigational tactics, as needed
7

Skills For Senior Manager European Scientific Publications Resume

  • Blood Glucose Monitoring and Insulin knowledge
  • Maintain a learning center repository to share current and relevant scientific materials
  • Develop product development plan for use as a guidance during the development of the target product
  • Problem solving: identifies technical problem with root cause
  • Leads or participates on global CMC teams while ensuring the defined scope, budget, and timelines of the program(s) are met with high-quality deliverables
8

Skills For Scientific Manager, Immunology Resume

  • Represents CMC on cross-divisional governance and development teams while providing strategy and accountability for CMC deliverables
  • Work with department heads, commercial, and legal to finalize proposals with pricing
  • Participate on ADC Core Teams, providing clinical insight for product development and use
  • Assist Clinical Affairs with development of protocols, CRFs, and training materials
  • Implement and support training programs, coordinate activities, information, and resources with other ADC personnel
  • Support regulatory document writing (IB, IND, scientific advice). Supports scientific advice meetings with regulatory authorities (EMA, PMDA, FDA)
  • Oversee the writing of the Immunogenicity Risk Assesment
9

Skills For Manager of Scientific Affairs Resume

  • Support PCA Skin & Elta MD regarding critical relationships and networks with current and future experts, academic institutions and dermal associations
  • Designs and executes, in cooperation with BRM Operations, adhoc experiments to develop new sample processing methods and techniques
  • Collaborates with biomarker and target discovery colleagues by supporting their sample needs
  • Supports sample inventory determinations relating to continued storage or destruction of samples
  • Risk Management – ability to identify/solve technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies
  • Resource Management – ability to manage internal and external resources (people, information, technologies, time, and capital) based on program needs
  • Work with NZ Universities to agree on and fulfill contract requirements including product grants and research projects. Schedule, and deliver lectures at NZ universities
10

Skills For Bioanalytical Scientific Manager Resume

  • Represent Colgate at key conferences to build and reinforce networks. Develop and deliver presentations to promote good oral health and highlight Colgate's good works and product portfolio. Engage other relevant speakers as required
  • Educate key Colgate employees in the science behind the products and dental/ oral health. Answer questions about products as necessary
  • Work with our Retail Marketing Team to run and participate in Shopper & Industry Events as required. Collaborate with marketing on the development of materials and programs
  • Transfers complex scientific content into understandable messages tailored to target groups
  • Direct, manage and develop staff to meet the department and AHA goals, if applicable
  • Direct invited program and abstract program for accredited scientific programs in collaboration with volunteer program committees
  • Manage the registration process for assigned specialty conferences

List of Typical Responsibilities For a Scientific Manager Resume

1

Responsibilities For Scientific Affairs Manager Resume

  • Proven track record establishing and maintaining scientific collaborative relationships with key opinion and thought leaders. PhD or MD required
  • Experience writing technical papers and making scientific presentations
  • Experience overcoming the challenges associated with synthesis of telechelic polymers
  • Demonstrated ability for innovative and big picture thinking
  • Negotiation and strong persuasive abilities, diplomacy and positive influencing abilities
  • Apply scientific principles, current technologies, and personal experience to design and execute appropriate experiments to solve a given problem
2

Responsibilities For Senior Scientific Manager Resume

  • Demonstrated ability to collaborate in and influence multidisciplinary teams
  • Above 5 years’ experience in VET industry for PETs
  • Experience with genetic and/or protein arrays
  • Documented scientific accomplishments as evidenced by publications
  • Knowledge of ring-opening metathesis polymerization (ROMP), dendrimer synthesis and rheometry
  • Support Scientific Communication by reviewing and editing press releases and provide input on media strategy/toolkits for scientific communication
3

Responsibilities For Senior Scientific Affairs Manager Resume

  • Multi-target antibody discovery and/or engineering projects
  • Knowledge and understanding of controlled polymerization techniques
  • Improve the continuous process for converting chain transfer agent (CTA) to macro-CTA
  • Use kinetic data to calculate operating conditions for pilot plant trials at MATRIC
  • Synthesize new chain transfer agents for efficient synthesis of polymers bearing four functional groups at each end
4

Responsibilities For Manager, Scientific Affairs Resume

  • Produce long telechelic polymers bearing four functional groups at each end
  • Prepare samples for external parties, including U.S. Air Force, U.S. Army, Shell Lubricants and Americas Autogas
  • To act as a CID diplomat with customers and professional organizations outside the United States
  • To keep CID informed of all activities and developments regarding clinical testing guidelines in the areas of autoimmune, infectious disease, and some specialty areas
  • Analyze and communicate scientific and clinical information
5

Responsibilities For Global Scientific Manager Cardiology Resume

  • High volume antibody/antigen production projects that require extensive design work
  • Aid CSO in all pre-work/research for projects to help generate project proposals
  • Once projects signed, manage project along with CSO and scientific directors; and
  • Assist in the lab with work as needed to move projects forward
  • Develop and maintain professional relationships with KOLs and academic centers that are of commercial and research relevance
  • Present scientific, clinical and educational materials to KOLs, academic centers, and professional diabetes organizations to gain awareness, acceptance, and advocacy of Abbott Diabetes Care products
  • Drive Publications and presentations of ADC products based on data and materials collected from KOL
6

Responsibilities For Scientific Services Manager Resume

  • Train health care professionals and physicians on ADC products
  • Act as resource to ADC with information, ideas and recommendations to R&D and other departments to monitor reactions related to Abbott Diabetes Care products
  • Assist with medical content review and professional communication materials and key advocacy initiatives
  • Coordinate and execute regional education and scientific symposiums Attend key regional and national scientific and medical meetings
  • Develop H/UPLC, CE, icIEF, Octet and ELISA based analytical methods for protein/antibody characterization
  • Perform formulation and stability studies
  • Facilitate the development of SOPs for various analytical methods and the qualification of methods required for technical transfer to our client
7

Responsibilities For Senior Manager European Scientific Publications Resume

  • Maintain and troubleshoot analytical instrumentation as required
  • Document experimental work in notebooks, SOPs and reports
  • Present results in department and company meetings with Therapeutic Discovery to conduct in-house Analytical
  • PhD in Biochemistry, Analytical Chemistry or related discipline with 0-2+ years of experience in the biotechnology industry; MS/BS in Biochemistry, Analytical Chemistry or related discipline with 2-5 years of experience in the biotechnology industry
  • Hands-on knowledge of technical scientific principles for most of the following analytical techniques: HPLC/UPLC (reverse phase, ion exchange, size exclusion); working knowledge of LC/MS is highly desirable
  • Strong analytical and critical thinking skills with the ability to interpret complex data
  • Strong ability to trouble-shoot technical problems
8

Responsibilities For Scientific Manager, Immunology Resume

  • Motivated self-starter who can work independently and collaboratively in a dynamic team environment with a proactive attitude
  • Developing and executing a highly efficient, integrated NAMA scientific strategy, including scientific evidence generation and scientific information exchange with all key stakeholders
  • Providing relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives and activities for Prostate Cancer
  • Ensuring that all Sanofi Oncology Prostate Cancer product data generated by the company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner
  • Working with the health economic team to generate and publish Real world Evidence
9

Responsibilities For Manager of Scientific Affairs Resume

  • Solid Tumor Oncology treatment expertise
  • Manage projects along with the scientific directors and our Chief Scientific Officer
  • Manage multiple projects and ensure smooth operations and communications
  • Potential for FTE projects that involve multiple business units across the company
  • Manage projects along with the scientific directors
10

Responsibilities For Bioanalytical Scientific Manager Resume

  • Accountable for the design of the bioanalytical strategy and the execution thereof (Pharmacokinetic, Immunogenicity and Biomarker)
  • Assures bioanalytical tasks are executed with good scientific quality, within the adequate quality system, and within the agreed upon timelines. This entails overseeing the execution by internal facilities or external vendors
  • Departmental representative in multidisciplinary project teams
  • Collaborate with multiple internal and external stakeholders (therapeutic area, quantitative clinical pharmacology, clinical operations, non-clinical safety, contract research organisations, …) to build and execute the bioanalytical strategy
  • Participate in preclinical study design and documentation, and in clinical study design and documentation (lab manual, protocol, SAP,…)
  • Participate in vendor governance through technical and study audits
  • Compliant towards the adequate quality systems (GLP, GcLP, GCP)
  • Extensive knowledge of a range of bioanalytical techniques including LC-MS/MS, Immunoassay, flow cytomety and quantitative PCR to support the analysis of Pharmacokinetic (NBE), Immunogenicity and Biomarker endpoints

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