Analytical Associate Job Description
Analytical associate
provides training and development opportunities for staff on general laboratory skills; reinforce regulatory concepts (cGMP) and laboratory techniques.
Analytical Associate Duties & Responsibilities
To write an effective analytical associate job description, begin by listing detailed duties, responsibilities and expectations. We have included analytical associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Be involved in method development and qualification and GMP material release by following procedures, comparability studies, impurity analysis, , using, CE-SDS, SDS-PAGE, cIEF and cell based methods
Participates in method development using HPLC, UHPLC, CE and other analytical instruments
Work with internal stakeholders and suppliers on projects as assigned
Assist the Regional Services team with the roll out process for new catalogs
Assist in the development/update of catalog standard operating procedures
Develop communications and transition plans for new catalog roll out process
Maintain a high level of industry and local market intelligence developing and utilising insurance market contacts (clients, brokers and regulators) carrying out desk-based research and analysis
Perform phase-appropriate analytical testings on small molecule and polymeric drug candidates
Leads communication and develops effective strategies & partnership with stakeholders from ADT, MS&T, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing
Supervises the management of analytical activities for commercial programs
Analytical Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Analytical Associate
List any licenses or certifications required by the position: FSCPA, MS, ASQ
Education for Analytical Associate
Typically a job would require a certain level of education.
Employers hiring for the analytical associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Chemistry, Science, Biochemistry, Biotechnology, Biology, Engineering, Education, Technical, Associates, Management
Skills for Analytical Associate
Desired skills for analytical associate include:
Basic chemistry and laboratory techniques
Analytical techniques used for product development and quality controls
Documentation requirements for cGLP/cGMP compliance
Laboratory equipment and procedures
Method development
Method validation
Stability analysis and setting of specifications
Analytical chemistry and related fields
Basic laboratory skills are
CGMP Quality system
Desired experience for analytical associate includes:
Ability to thrive in a multi-tasking and complex environment
Leads effective analytical support during all ROW & PAS filing review and to work with analytical development in supporting the responses to FUMs and PMCs
Co-lead the effort to implement effective analytical method and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs
Coordinates optimization and improvement of analytical program support
Demonstrates a broad expertise and experiences in biophysical and biological analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product
Comprehensive knowledge of biologics CMC regulations and cGMP requirements, , experience in supporting regulatory filings
Analytical Associate Examples
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Analytical Associate Job Description
Job Description Example
Our innovative and growing company is looking for an analytical associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for analytical associate
- Develop WPDs and SOPs, qualification and validation protocols and reports and technical protocols and reports as assigned
- Maintain knowledge of current scientific principles and theories
- Performs routine equipment monitoring and cleaning
- Learning to plan assigned workload on a daily basis and effectively schedule multiple assignments
- Contributing to a cohesive team environment
- Maintaining a clean and safe laboratory work environment
- Manage the day-to-day operations within the Biologics Testing Solutions department
- Provide scientific and technical leadership within the Biologics Testing Solution business unit to resolve analytical challenges in a timely fashion, and to evaluate new technologies for potential integration into existing portfolio of services
- Ensure effective communication within departmental groups, in order to provide overlap of diverse expertise
- Integrate activities with those of other major organizational units
Qualifications for analytical associate
- Thorough knowledge of techniques required for physicochemical characterization of drug substance
- Demonstrated leader of teams of scientists and/or project management professionals
- PhD or MS in Biological Sciences, Chemistry, or related disciplines
- At least 10 or 13 years of industrial experiences in relevant fields, respectively
- Extensive hands-on experience with separations techniques (HPLC, UPLC, GC)
- Experience with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations
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Analytical Associate Job Description
Job Description Example
Our innovative and growing company is hiring for an analytical associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for analytical associate
- Manage a portfolio of government ratings across the Sovereign and International Public Finance team with a focus on Greater China and Southeast Asia
- Develop recommendations and assignment of ratings to governments and public sector companies, their debt instruments, in accordance with Standard & Poor’s rating criteria
- Function as a technical resource for analytical methods and data troubleshooting, remediation, and optimization in support of Manufacturing Process activities
- Represent PDS AD in new project discussions with clients
- Undertakes analytical testing using established methods and generate high quality data to support internal drug development activities
- Performs degradation studies to support impurity identification and characterization
- Maintains accurate records of experiments and communicate effectively to the analytical team on analytical findings, issue and solutions
- Ability to multi-task to meet aggressive timelines, and technology development and research goals
- Presents the results/findings internally and to cross functional teams
- Provide content and review relevant sections of regulatory submissions
Qualifications for analytical associate
- BS or MS in Pharmaceutical, Analytical, or related Chemical field
- Advanced Degree in Chemistry strongly preferred
- Able to organize his/her own work on a routine basis and requires minimal supervision
- MS/BS in relevant field
- Considerable understanding of analytical instrumentation and how it operates
- BS/BA in a life science field, advanced degree preferred
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Analytical Associate Job Description
Job Description Example
Our company is growing rapidly and is looking for an analytical associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for analytical associate
- Support Process Development upstream and downstream activities for early and late phase biologics process development
- Responsibilities include reagent preparation, performing assays, data processing, electronic notebooks and LIMS entries in a timely manner
- Support PD and network labs analytical requirement in a timely manner
- Data analysis and presentations at internal and external meetings
- Develop and implement analytical methods for release and stability testing for drug substance and drug product
- Manage formal and informal stability studies, apply statistical methods of analysis, and guide project team activities based on stability outcomes
- Serve as direct supervisor to Associates and Scientists within the group, providing technical mentorship and attending to long-term skills development
- Requires supervisor duties
- Of proteins/mAbs manufactured
- Plan, seek input, negotiate, and execute all analytical testing activities to support specification development for new products and management of test changes to commercial products
Qualifications for analytical associate
- A minimum of 0-5% travel is required for this role
- Minimum of 10 years of experience in biologics development, preferably having a strong background in the analytical analysis of biopharmaceuticals
- Broad knowledge and understanding of the biologics development process as applied to the integration of process development, formulation and stability, and analytics to develop a specification
- Demonstrated leadership capability to achieve success when working and leading virtual teams in a matrix organization
- Demonstrated ability to operate independently and have appropriate judgement to make or facilitate decisions, particularly as related to the BSC
- Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the biopharmaceutical landscape for the development of various quality system frameworks
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Analytical Associate Job Description
Job Description Example
Our growing company is looking for an analytical associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for analytical associate
- Identify and qualify suitable laboratory resources to outsource analytical testing for active substance, drug product, packaging material and other related components
- Anticipate, manage, and resolve analytical testing problems
- Develop testing requirements appropriate for different phases of active and product development, regulatory approval and commercialization
- Write, review and oversee data summaries and reports for internal, client, partner and/or regulatory use (e.g., stability reports)
- Interact effectively with Project Team members, senior management, external partners/vendors, FDA, and other governmental agencies as appropriate
- Collaborate with Project Coordination group to complete projects based on timelines that maximize value to the company
- Comply with all applicable cGMP, GLP and other (e.g., environmental) regulations
- Design, perform, and interpret experiments, with minimal supervision, to support analytical development objectives as part of a high throughput testing team
- Candidate will analyze discovery bipharmaceutical research and discovery (R&D) samples
- Support the identification and optimization of drug candidates across modalities
Qualifications for analytical associate
- Success in undefined or ambiguous environments
- Demonstrated excellence in developing key stakeholder buy-in
- Demonstrated ability to drive performance and achieve results
- Demonstrated ability to identify and develop synergies, across functional and business organizational lines that support BSC strategic objectives
- Superior communication, relationship management, negotiation, analytical and problem-solving skills
- This role can sit at other US based BMS sites
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Analytical Associate Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of analytical associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for analytical associate
- Develop appropriate analytical methodology and procedures following US FDA guidelines
- Perform Good Manufacturing Practice (GMP) stability testing of substances/drug products
- Assist in performing instrument set-up, operation, and maintenance
- Prepare protocols, reports, and project summaries
- Communicate analytical results and project status to management
- Fulfill responsibilities of Study Director/Principal Investigator, as prescribed in departmental SOPs and appropriate Good Laboratory Practice (GLP) regulations/standards
- Responsible for managing a portfolio of government ratings across the Sovereign and International Public Finance team with a focus on Greater China (local government, government related, and other public sector entities)
- Develop recommendations and assignment of ratings to public sector companies and governments, their debt instruments, in accordance with Standard & Poor’s rating criteria
- Performs experiments to evaluate analytical methods associated with commercial products for method improvement, remediation and/or troubleshooting
- Identifies appropriate analytical methods and executes experiments to support investigation associated with supply chain security
Qualifications for analytical associate
- Advanced degree in Chemistry, Pharm
- Bachelor's Degree in a Life Sciences discipline or equivalent, Analytical Chemistry degree preferred
- Minimum of four (4) years of experience in a QC laboratory of a GMP regulated manufacturing facility
- Minimum of 2 years’ experience performing HPLC or Mass Spectrometry analysis
- Proficiency with Chromeleon and MassHunter preferred
- Experience with quality and stability testing a plus