Senior Associate Scientist Job Description
Senior associate scientist
provides technical leadership in synthetic organic chemistry and medicinal chemistry and often direct external CRO resources.
Senior Associate Scientist Duties & Responsibilities
To write an effective senior associate scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included senior associate scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Contribute to the writing of non-clinical pharmacology study reports, invention disclosures, and contribute to the writing of investigator brochures, IND applications, regulatory annual reports, and other regulatory documents when appropriate
Algorithm development and optimization, working with software engineers to implement and productize the models and algorithms, engage in project specific activities as part of product development, perform cognitive research and development (R&D) work, develop tools and assets to support advanced cognitive development tasks
Complies with all relevant cGMP and/or GLP regulatory requirements while carrying out assigned studies
Perform routine fermentation lab operations, design and execute experiment plan and monitor processes to ensure consistency and reliability
Method qualification, validation and transfer activities of new bioassays, immunoassays, and nucleic acid assays to be used as QC potency assays
Specific tasks would include writing validation protocols, reports, and performing and coordinating testing to support manufacturing process development, process validations, and manufacturing investigations across functional groups
Accurate capture of data in a timely manner and entry into appropriate systems
Providing technical support for early development technologies and QC laboratories is expected and the successful candidate will also support Quality Assurance, Regulatory Affairs and Process Development groups for all phases of product development ongoing support of analytical methods for marketed products
Responsible for technical oversight of multiple oligonucleotide programs in preclinical, clinical (Phase 1 through Phase 3/marketing application), and post-approval stages including candidate products for cancer and vaccines for infectious disease
Design CMC approaches for all oligonucleotide programs to rapidly move the programs forward, and implement approaches in collaboration with Dynavax teams and contract manufacturers
Senior Associate Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Associate Scientist
List any licenses or certifications required by the position: AALAS, ASCP, HTL, LATG, HT, DAWIA, ASR, LAT, SRA, DABT
Education for Senior Associate Scientist
Typically a job would require a certain level of education.
Employers hiring for the senior associate scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Engineering, Biology, Biochemistry, Science, Computer Science, Statistics, Biotechnology, Molecular Biology, Chemical Engineering
Skills for Senior Associate Scientist
Desired skills for senior associate scientist include:
Synthetic organic chemistry principles
Pharmacology
Microsoft Office
Data acquisition and controls systems in these environments is desirable
Empower software
GLP and GMP requirements are
Protein biochemistry and analytical chemistry
SDS-PAGE
Synthetic organic chemistry reaction mechanisms and reactivity
Analytical instrumentation and wet chemical techniques with strong focus on HPLC
Desired experience for senior associate scientist includes:
Direct interaction with Process Development, Quality Assurance, Quality Control, Project Management and customers is expected, therefore, good communication skills (oral and written) are essential
Ability to apply and incorporate pharmaceutical standards and rules, as per ICH Q7, into documents and day-to-day practice
Ability to identify potential safety, quality and compliance risks associated with technology transfer and scale-up, and propose solutions to mitigate risk prior to GMP Manufacturing operations
Serve as the technical manufacturing or support lead on pilot scale and full scale manufacturing of new APIs
Experience with bench-top and/or pilot plant fermentor operations
M.Sc with at least 3 years’ experience in industry
Senior Associate Scientist Examples
1
Senior Associate Scientist Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of senior associate scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior associate scientist
- Lead process development, scale-up, technology transfer and process validation activities
- Lead the implementation of Quality by Design (QbD) approaches for oligonucleotide development
- Lead outsourcing of Dynavax’s oligonucleotide API supply requirements, including vendor selection and contract negotiation as needed
- Author oligonucleotide CMC regulatory packages
- Execute, under supervisor’s direction, the development of in-vitro and ex-vivo assays to translate preclinical data into clinical biomarkers for advancing drug candidates through clinical trials
- Contribute to and help coordinate collaborative efforts, both internally and externally
- Generate, analyze, and report experimental results
- Participate in Immuno-oncology team meetings to present data and provide analysis
- Maintain familiarity with current techniques and procedures
- Assist with the evaluation of innovative technologies directly related to Immuno-oncology biomarker development
Qualifications for senior associate scientist
- Experience with gene therapy and/or vaccines would be preferredR&D
- PhD in chemistry or related scientific discipline with 5+ years’ relevant work experience, including 2 years’ in a leadership role in a CMC discipline such as process development, formulation
- Must have experience authoring CMC sections of Regulatory submissions
- Proven success in leading multidisciplinary project teams
- Expertise with oligonucleotide or small molecule drug development, scale-up and manufacturing for pre-clinical and clinical stages
- Must be a proven successful leader in building positive relationships across functional lines and able to influence positive decisions and build consensus
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Senior Associate Scientist Job Description
Job Description Example
Our growing company is looking for a senior associate scientist. 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 senior associate scientist
- Identify process improvement opportunities and lead the implementation of these initiatives
- Monitor product performance to assess process capability and statistical control to ensure product validation status
- Identify trends and implement corrective actions as applicable
- Investigate and troubleshoot product deviations and production trends using technical and scientific skills
- Determine, along with team, corrective and preventive actions using the appropriate root cause analysis tools
- Work with other teams to address and solve technical issues
- Coordinate and monitor laboratory testing of experiment samples
- Develop and review validation protocols, coordinate resources, schedule qualification/validation runs and present results and conclusions
- Develop metrics and trending reports, initiate change controls, execute data analysis, participate in audits and manage projects of medium complexity
- Knowledgeable in protein science, cell culture and protein expression
Qualifications for senior associate scientist
- PhD -3+ years’ experience in open source programming languages for large scale data analysis
- Previous experience setting up cell based assays (proliferation, ELISAs, transfections, siRNA/shRNA knockdown) is required
- Execute and document work with great attention to detail
- Ability to prioritize tasks and fluidly transition between methods to perform tasks for multiple concurrent projects
- Working knowledge of GLP, CLIA and other applicable regulations/guidelines
- Must be productive within a team and as an individual contributor in a dynamic environment
3
Senior Associate Scientist Job Description
Job Description Example
Our growing company is looking for a senior associate scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for senior associate scientist
- Test samples from the process for cell viability, cell density, metabolites and titre and additional tests as required by the experimental plan
- Provide technical support for ongoing cell culture processes at laboratory and manufacturing scale
- Participate in maintaining scale-down models of the commercial or clinical process
- Effective execution of experiments and basic problem solving
- Ability to solve moderately complex issues independently
- Exercise significant technical discretion in the design and execution of a wide variety of experiments including quantitative data analysis and interpretation of results
- Use results to design new experiments
- Write complex protocols and technical reports
- Routinely identify new areas requiring evaluation
- Identify and troubleshoot complex manufacturing problems
Qualifications for senior associate scientist
- Must have established business acumen evidenced by successful achievements and contributions of new technologies, applications, and/or business opportunities
- This position may require travel up to 10%
- Extensive hands-on experience in direct binding studies using SPR is required
- Extensive experience and knowledge in majority of the following areas
- Execute formulation development activities such as performing hands on execution of experiments in laboratory prototyping, material characterization
- Experience in validation and qualification, troubleshooting, and technical writing is required
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Senior Associate Scientist Job Description
Job Description Example
Our company is searching for experienced candidates for the position of senior associate scientist. 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 senior associate scientist
- Make contributions to scientific publications and regulatory submissions
- Good knowledge of GMP manufacturing and process transfer
- Ability to resolve process development issues
- Ability to take a leadership role in groups and to influence others effectively
- Support all activities related to the MSAT lab in which harvest clarification, purification and analytical testing activities are performed
- Interface within MSAT team, Manufacturing, Quality, Validation, Quality Control, Lab Services and Facilities Services
- Ability to use computer effectively as work requires
- Apply a basic knowledge of biological manufacturing science in the design and execution of bioreactor experiments to identify and validate critical parameters that affect upstream bioprocess performance across multiple scales
- Working with senior level Scientists to systematically optimize the parameters that affect bioreactor performance through the application of statistical models for experimental design and analysis
- Subject matter expert in the CoE for assay development according to international guidelines
Qualifications for senior associate scientist
- Extensive hands-on experience with modeling software like S-PLUS/R, NONMEM, S-ADAPT, WinBUGS/OpenBUGS
- Experience supporting clinical development in the Oncology, Cardiovascular Disease, Immunology and/or Fibrosis is preferred
- Master’s degree or Ph.D in Computer Science, Applied Statistics, Engineering, Mathematics, Physics or other quantitative discipline with specialization and experience in Artificial Intelligence, Machine Learning, Natural Language Processing, Cognitive Science or other related areas
- A minimum of a M.S
- Experience in handling high-dimensional single cell data, mass cytometry, high-content imaging derived features is required
- Intermediate knowledge in chemistry, biology, biochemistry, and math, understanding of current Good Manufacturing Practices is required
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Senior Associate Scientist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of senior associate scientist. 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 senior associate scientist
- You are able to apply skills and knowledge to all stages of chemical synthesis
- You support the management of intermediates testing, including technical review of draft protocols and study reports, help with program workflow
- You work reciprocally with internal groups
- Develop cell-based assays to be used in target validation studies
- Conduct cell-based assays based on various cell viability, apoptosis induction, and metabolomics readouts to enable a mid-stage drug discovery project
- Engineer cell lines (stable knockdown and/or overexpression) to test specific biological hypotheses
- Maintain good written records of laboratory procedures, results and conclusions
- Perform and report interim analysis of accumulated data to monitor work progress
- PhD with 0-2 years of post-doctoral experience
- Exceptional cell biology techniques (mammalian cell culture, transfections, and RNA interference)
Qualifications for senior associate scientist
- Experience in molecular biology, gene construct design and molecular cloning, reporter gene assays and engineering stable cell lines to support cell based assay development would be preferred
- Familiarity with analytical instrumentation and cGMP process equipment is desired
- Our Sr
- Specific Personnel Protective Equipment (PPE) is required when working in classified rooms
- Certain APIs, are considered high potent compounds
- BSc, MSc in microbiology, cell biology and physiology, chemical or biochemical engineering with 2-5 years’ experience in the industry for bioprocess development for manufacturing of high-value biological products