Analytical Development Job Description
Analytical development
provides technical support in the lab performing HPLC, KF, dissolution, troubleshooting, and method development.
Analytical Development Duties & Responsibilities
To write an effective analytical development job description, begin by listing detailed duties, responsibilities and expectations. We have included analytical development job description templates that you can modify and use.
Sample responsibilities for this position include:
Setting strategy for evaluating and implementing new technologies within the Analytical Development department, with a particular emphasis on state of the art separation techniques (HPLC/UPLC and CE) and automation
Communicate with development SME and lead assist in method remediation/trouble shooting
Perform analytical characterization of therapeutic glycoproteins
Authorize electronic notebook, SOPs and study reports
Develop new techniques two expand the analytical capacity
Coordinate activities with manufacturing, discovery and external contract organizations
Develop analytical methods that are accurate, precise, specific, and robust
Author method validation protocols
Execute method validation and prepare the necessary reports
Reviews analytical chemistry testing records of raw materials, stability, and product for accuracy and adherence to test methods
Analytical Development Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Analytical Development
List any licenses or certifications required by the position: GMP, SOP, AD
Education for Analytical Development
Typically a job would require a certain level of education.
Employers hiring for the analytical development job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Biochemistry, Science, Biology, Engineering, Pharmacy, Biotechnology, Chemical Engineering, Education, Life Sciences
Skills for Analytical Development
Desired skills for analytical development include:
GC
Biopharmaceutical classification system
IVIVC / IVIVR
Dissolution method development and testing
HPLC
Scientific principles and basic understanding of applicable drug development regulations
KF
Applicable regulatory authority
Compendia and ICH guidelines
Current Good Manufacturing Practices
Desired experience for analytical development includes:
Knowledge and expertize in working with CRO/CMO on method development and qualification is a must
Working knowledge of cGMP compliance as related to analytical laboratory
Actively participates in investigations, problem solving and trouble shooting
Proactively identifies potential problems and recommends potential solutions
Prepares and presents data summaries
Assists in the development and implementation of training programs that govern general and analytical chemistry specific laboratory practices
Analytical Development Examples
1
Analytical Development Job Description
Job Description Example
Our company is growing rapidly and is hiring for an analytical development. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for analytical development
- Must be fluent in both English and Chinese
- Act as a spokesperson, internal consultant, or advisor to top management on corporate research and development direction in the region
- Ability to think critically and creatively, and act strategically
- Expertise in overseeing GMP work at a contract partner site is higher desirable
- Knowledgeable about cFDA expectations on Quality Systems new product submissions
- Ability to work independently and determine appropriate resources for resolution of problems, and have strong organizational and planning skills
- Works on a wide range of problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity
- Good working knowledge in statistical software and able to perform data trend analysis and assist in investigations
- Experienced in Empower, LIMS Labware, and Trackwise and able to perform electronic data review
- Thorough understanding of standard QC laboratory activities such as equipment maintenance and qualification, training programs, analytical method validation, method transfers, method monitoring, out-of-specification handling, and stability testing
Qualifications for analytical development
- 18+ years of relevant analytical development experience with biologic/biotherapeutic products in the pharmaceutical industry with exposure to all stages of product development
- Demonstrated track record in robust analytical development leading to assay qualification and validation
- Deep technical understanding of all aspects pertaining to analytical testing and characterization of biological products
- Solid understanding of how Pharmaceutical Development integrates with key business partners
- Track record of successful pharmaceutical product development
- Experience in budget management, and managing scientific staff from a budgetary and personnel standpoint
2
Analytical Development Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of analytical development. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for analytical development
- Overseeing the department’s GMP sample support, including IPC, release and stability testing, performed in house at CRO, and directing GMP investigations including deviation root cause analyses, CAPA, and out-of-specification
- Providing strong scientific mentorship to direct reports who have both managerial and CMC analytical project leadership roles that support process development, specification setting, and CMC regulatory filings and responses
- Designing and adapting analytical paradigms based on the CQAs, process control strategies and emerging industry trends
- Participate in teams consisting of analytical, manufacturing, process development, quality, regulatory, supply chain, Work with other groups to develop timelines and effective strategies to meet the clinical supply demands and supply chain needs
- Prepare well for calls/visits, anticipating and addressing barriers
- Establish strategic sales growth plan through development and regular update to Sales Target Reports
- Create and maintain business relationships with key customers, operations and management through regularly scheduled meetings, anticipating customer needs and ensuring operational excellence
- Manage the business relationships with assigned customers
- Understand the customer’s decision making processes and identify each key decision maker’s individual issues and personal wins
- Conduct discussions (internally and with customers) and analysis to identify opportunities for innovation
Qualifications for analytical development
- The ideal candidate will also have experience in interacting with CROs, including oversight of assay development and method transfer
- Demonstrated situational leadership skills
- PhD in a biochemistry, biophysics, or chemistry-related field
- 10 years of experience in Analytical Development, with a minimum of 5 years of managerial experience
- Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development
- Experience leading teams in the development, qualification/validation and transfer of analytical methods
3
Analytical Development Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of analytical development. 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 development
- Ability to perform minor analytical chemistry or physical testing under management or experienced analysts supervision
- Assist laboratory analysts and scientists in preparing of analytical reagents and solutions required for testing
- Organization and completion of shipping documentation and entering of data into the database
- Control inventory, order laboratory supplies and other materials required for the normal and productive lab operation
- Control laboratory glassware cleaning process and clean glassware and non-glass lab ware requiring manual cleaning
- Perform laboratory housekeeping, support lab cleaning process
- Update and maintain analytical data, sample and instruments logbooks
- Monitor laboratory inventory of reagents and supplies
- Enables learnings across programs by forcing alignment across projects and regulatory submissions
- 75% Executing laboratory procedures and experiments
Qualifications for analytical development
- Working knowledge of cGMP, FDA, ICH, USP, and other regional and country specific guidances
- Experience writing regulatory submissions, audits and meetings
- Experience in planning and implementing analytical and CMC strategy for the development of large molecule biologics or gene therapy
- Understanding of how QbD, CQAs and process control strategies are related
- Excellent oral and written communication skills, who is self-motivated #LI-GZ
- MS/BS/BA in relevant field and 2-5 years of relevant experience
4
Analytical Development Job Description
Job Description Example
Our growing company is looking for an analytical development. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for analytical development
- Oversee installation of laboratory equipment in collaboration with Facilities
- Manage equipment qualifications and/or calibrations per internal procedures and USP guidelines
- Coordinate equipment preventative maintenance and repairs with Facilities and/or external vendors
- Troubleshoot equipment issues and determine proper method of repair
- Initiate and follow-up on equipment repairs with Facilities and/or external vendors
- Act as a resource and liaison between scientists and support groups
- Act as a Principal responder for equipment alarms
- Coordinate Facility work orders
- Coordinate IT R&D Applications support requests
- Ability to work with a wide variety of colleagues within Product Development and from other functions different levels of Management
Qualifications for analytical development
- The Director will be responsible for guiding the commercialization of analytical methods that are “fit for purpose” and meet current agency expectations
- Accountable for driving resolution of biologics manufacturing process challenges, for ensuring knowledge management and sharing of best practices for biologics DS/DP tech transfers and commercial process lifecycle management
- Knowledge of physical pharmacy and organic chemistry, and expertise in two (2) or more of the following subjects is preferred
- Teamwork -- Works well on global cross-functional teams
- Knowledge Sharing - Ability to capture organizational knowledge organization
- Experienced in the validation requirements for analytical methodology in the pharmaceutical industry (MHRA / FDA / ICH )
5
Analytical Development Job Description
Job Description Example
Our company is growing rapidly and is hiring for an analytical development. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for analytical development
- Review of internally and externally generated raw data
- Appropriately apply the cGMP between regulated and non-regulated activities
- Collaboratively plan and execute cross functional studies for chemical development and formulation development
- Independently plan, execute, and justify in-house stability studies for drug substances, intermediates, and prototype drug products
- Ensure records of laboratory work are complete, accurate, and in conformance with company SOPs and training
- Together with analytical project leaders, drive scientific studies to justify specifications
- Initiate/manage change controls to support the creation/revision of specifications
- Facilitate Specification Committee meetings to propose/review/justify the phase appropriate specifications, prepare/organize analytical data for review by the Specification Committee, build statistical data analysis and process capability analysis into justification of specifications, generate meeting minutes to capture issues, decisions, and action items
- Develop/maintain internal guidelines and procedures for proposing new or revision of specifications
- Establish an information management system to capture relevant project data, assay performance, and analytical development information to create and maintain a comprehensive analytical knowledge base
Qualifications for analytical development
- Requires minimum B.S
- 10+ years’ experience in analytical development in a pharmaceutical setting
- Experience in oversight of CMOs for drug substance and drug product manufacturing for method development, characterization and technology transfer preferred
- BS/BA degree is required in a scientific or business related discipline
- Significant experience in sales for solid oral development and analytical CMC support
- Must have a good knowledge of English both oral and written