Scientist, Development Job Description

Scientist, Development Job Description

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Scientist, development provides chemistry expertise to site Technical, Quality, Engineering and Operations leadership to aid in the development of a long-term pharmaceutical manufacturing strategy.

Scientist, Development Duties & Responsibilities

To write an effective scientist, development job description, begin by listing detailed duties, responsibilities and expectations. We have included scientist, development job description templates that you can modify and use.

Sample responsibilities for this position include:

Develop monthly and quarterly forecasts annual plan
Preparation of culture media and other reagents
Development of robust sample preparation protocols from a wide range of biological sample types
Optimization of real time reverse transcriptase and/or PCR assays
Testing and optimization of existing and novel detection chemistry
Integration of the designed assay system with sample preparation, amplification and detection instrumentation
Using statistical tools for analysis of data
Order and stock laboratory supplies for continuous and consistent workflow
Perform custom labeling and assay development tasks in laboratory
Able to independently analyze simple experimental data provide and present conclusions

Scientist, Development Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Scientist, Development

List any licenses or certifications required by the position: MIL, GMP, SOP, ISO, GDD, IOPP, PMP, PE

Education for Scientist, Development

Typically a job would require a certain level of education.

Employers hiring for the scientist, 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, Science, Engineering, Biochemistry, Biology, Chemical Engineering, Education, Microbiology, Supervision, Technical

Skills for Scientist, Development

Desired skills for scientist, development include:

Biochemistry
Chemical engineering principles and applications
General chemistry and separation science
Machine learning techniques
Pharmaceutical manufacturing equipment
Pharmaceutical technology
Practical experience in testing
Predictive modeling
Protein and peptide chemistry
Python

Desired experience for scientist, development includes:

Attention to detail, methodical and meticulous in approach to problems
Responsible for documentation of studies performed
Candidates must have training in life sciences
Development of reagent preparation methods and test protocols for transfer to manufacturing
Characterization of reagents and standards for DNA/RNA, extraction, purification, and qPCR
Writing laboratory reports, SOPs and supporting quality documentation

Scientist, Development Examples

1

Scientist, Development Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of scientist, 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 scientist, development
  • Scale assays to work on >10,000 strains per week via software + automation
  • Collaborate with software engineers to ensure that all data is captured, stored, and analyzed in Ginkgo's LIMS
  • Responsible for the development of molecular diagnostic assays in the area of infectious disease
  • Responsible for execution of assay development activities through the feasibility, development, and verification and validation stages of product development cycle
  • Development of robust sample preparation protocols from a wide range of biological sample type
  • Development of Primer/Probe design for molecular assays
  • Characterization of enzymes for molecular processes involving nucleic acids, lipids, and proteins
  • Characterization of steps during extraction and purification of nucleic acids
  • Lead/facilitate/participate in technical meetings within discipline/department
  • Author and drive requirements definition for assigned unit of work
Qualifications for scientist, development
  • Strong ability to build lasting relationships between assay development, manufacturing and quality regulatory teams
  • Bachelor’s of Science degree with 2-6 years work experience in Pharmaceutical Industry or Master’s degree in Pharmaceutical Sciences, Polymer Chemistry, or Chemical Engineering with 0-4 years work experience
  • Demonstrated ability to develop novel assays and optimize conditions to reduce variability
  • Enzymology experience a plus
  • Familiarity with software, programming, or laboratory automation a plus
  • Familiarity with diverse microbes, including plant-associated microbes, a plus
2

Scientist, Development Job Description

Job Description Example
Our innovative and growing company is looking for a scientist, 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 scientist, development
  • Troubleshoot assay problems
  • Reads and critically evaluates the literature in the bioanalytical field in order to develop novel approaches to develop and perform assays
  • Communicates effectively with supervisor and other managers within the Assay Development Group
  • Write development and validation reports and SOPs
  • Screen assay materials
  • Achieve project goals in a timely manner and with a high degree of quality
  • Undertake original and innovative research and techniques that includes developing and qualifying ligand binding assays utilizing state-of-the-art technologies for the rapid and accurate analysis of protein/peptides/ antibodies in biological matrices
  • Support associate director in achieving challenging business objectives for method development team
  • Develop methods by applying and interpreting scientific theories, concepts, techniques, and regulatory requirements in bioanalytical studies
  • Provide technical/scientific guidance and leadership to study teams, other areas of the company to ensure project completion in timely manner
Qualifications for scientist, development
  • Strong ability to build lasting relationships between assay development, platform development, manufacturing and quality teams
  • Must be willing and able to be hands-on in the laboratory, capable of designing and performing experiments supervising others performing them
  • Substantial hands-on experience with clinical immunoassay R&D
  • Experience and recent practice in lab settings and willingness and ability to productively work in lab settings
  • Highly proactive and self-directed in identifying personal team-wide knowledge and/or skill gap, and adept at acquiring the technical background needed to fill those gaps
  • PhD in Life Sciences
3

Scientist, Development Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of scientist, 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 scientist, development
  • Designing and supervising in vitro and in vivo toxicology studies, working closely with Study Monitors, Pathologists, and Pharmacokinetics’s to deliver high quality GLP and non-GLP study reports, authoring and reviewing regulatory documents, and representing Genentech in meetings with regulatory authorities
  • Leading hypothesis-driven investigation into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees
  • Represent Safety Assessment on interdisciplinary research and development teams and contribute to scientific and strategic decision making in order to bring next generation therapeutics to patients
  • Additional responsibilities include leading or supporting inter- and intra-departmental initiatives
  • Keep all records and lab notebooks in good order
  • Keep the work area clean and organized
  • Supervisor and responsible for particular laboratories and equipment dedicated to the work area including contact person for maintenance activities, writing of work and equipment SOPs troubleshooting support
  • Independently develop and optimize robust, economical purification processes for monoclonal antibodies and recombinant proteins
  • Conduct and monitor laboratory experiments for verification and validation of prenatal diagnostics and screening tests for regulatory submission for Lab-developed Tests and Medical Devices for the domestic and international markets, including experimentation to support ongoing long term stability studies and to aid in troubleshooting of product -based issues
  • Planning and execution of laboratory experiments for both individual and team–based projects
Qualifications for scientist, development
  • Good color vision is mandatory
  • Experience in engineering plastics coloring and compounding is preferred
  • PhD in Biology, Immunology or a related field
  • 1 year of biotech/pharma/CRO experience with biotherapeutics preferred
  • Experience in the development/validation of ELISAs and/or MSD assays for protein biopharmaceuticals in a regulated environment under GLPs
  • Experience with other assay platforms is a plus
4

Scientist, Development Job Description

Job Description Example
Our growing company is hiring for a scientist, 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 scientist, development
  • Supports and trains new team member or apprentices/internships
  • Operation of lyophilisation and formulation equipment (particle sizing, DSC, microscopy ), is preferred
  • Write project reports
  • Be the technical lead and point of contact to some of our key Food Service customers
  • The ideal candidate needs to have completed a Food Science curriculum and understand and apply effective skills in project management, food chemistry, food process technology, microbiology, sensory science, record keeping and laboratory safety
  • Design and develop new products from bench top to commercialization while staying within specified parameters of cost and label claims
  • Act as scientific, regulatory, technical or quality expert and consultant by responding to targeted questions from the field or other departments/ business units
  • Responsible for on time delivery targets (protocols/results/reports)
  • Responsible for Gap Analysis when Developing/Establishing methods
  • With minimal supervision, exercise technical discretion in the design, execution and interpretation of experiments that contribute to the advancement of development programs
Qualifications for scientist, development
  • PHD and two years industrial experience or a Master’s degree with five years relevant industrial experience
  • Strong assay development, analytical and troubleshooting skills
  • Experience in molecular biology reagent manufacturing processes
  • Prefer experience in Lean Six Sigma, DOE and statistical analysis
  • Prefer experience with ERP system – SAP preferred
  • Must have personal accountability for results
5

Scientist, Development Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of scientist, 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 scientist, development
  • Communicate with staff in other departments and with external entities to ensure smooth running of projects, providing timely support & feedback as agreed
  • Delegate for R&D Manager in project meetings when required
  • Undertakes original research that includes developing and confirming highly sensitive, reliable assay methodologies for the rapid and accurate analysis of pharmaceuticals in biological fluids and tissues
  • Performs complex analytical methods on biological matrices, often involving problem solving situations
  • Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in bioanalytical and mass spectrometry studies and accepts leadership role in developing scientific approaches
  • Acts as research scientist, in a team work setting, for technical direction on complex bioanalytical and mass spectrometry projects
  • Responds to unscheduled deadlines, client needs, crises, without neglecting other duties
  • Produces reports for reliable, sensitive, and validated methods of analyses
  • Authors scientific papers which are published in peer reviewed journals
  • Contributes to long-range planning and technical policies of the department
Qualifications for scientist, development
  • HS/GED/Associates and 15+ years of relevant experience (preferred)
  • Proficient using laboratory software applications and LIMS
  • Strong working knowledge of resin synthesis at a lab, pilot and manufacturing scale
  • Basic understanding of a broad range of analytical techniques, including rheology, thermal analysis, and various chromatography and spectroscopies
  • Leadership experience in implementing process and equipment changes
  • Ability to engage across multiple organization including R&D, manufacturing and business organization

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