Scientist Ii Analytical Jobs in Massachusetts

Knowledge in safety, quality management, IP Management

Organizational and project management skills

High school diploma/GED with 8+ years of exceptional industry experience

Associates degree with 4+ years of experience

Bachelor’s degree with 1 year of experience

Knowledge of respective chemistry, processing, structure property, relationship

Bachelor/Master of Science in Biology, Molecular Biology, or Biochemistry, with a minimum of 5 years’ industry GLP/GMP experience.

Experience in running stability protocols with associated experimental planning and data collection and analysis.

Strong written and oral communication skills.

Develop, qualify, and implement biophysical assays to support early and late-stage vaccine development programs.

Author, review, and approve SOPs, study protocols, reports, and other scientific and quality documents.

Thorough and accurate documentation of work

Generate, manage, evaluate, and maintain critical data in a highly organized manner, providing statistical analysis and troubleshooting where appropriate.

PhD in Molecular Biology or another related discipline with 2-5 years of relevant experience

Extensive experience using molecular biology techniques, such as PCR, dPCR and TIDE

Proficiency in cell & tissue culture (cell lines; experience with hepatocyte culture is a plus), transfection,

Experience with protein extraction, and western blots

Knowledge of CRISPR/Cas9 Gene Editing

Participate in cutting-edge technology development and establish internal and external partnerships to build Takeda's scientific capabilities.

Perform non-GMP method qualification for different biophysical assays and particulate characterization methods.

Lead the characterization of biologics including the qualification of reference standards, in-depth structure/function studies, product comparability and investigations.

Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical sciences with 8+ years relevant industry experience.

Master’s degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical sciences with 6+ years relevant industry experience.

PhD in chemistry, biology, pharmacy, engineering, or related pharmaceutical sciences with 0+ years relevant industry experience.

Good time and project management skills, ability to oversee several projects simultaneously.

Knowledge and skills in chemistry, biochemistry and microbiology.

Comply with institutional certifications and requirements in a BSL-2 environment.

Responsible for development, qualification, documentation, and transfer of assays.

Virology knowledge (especially flavivirology) is highly desirable.

Training and experience in Design of Experiments and other statistical methodologies.

2+ years of relevant experience in an analytical laboratory setting.

Previous experience with HPLC, LCMS, MALDI-TOF MS, and UV-Vis

Preferred - experience with oligonucleotides.

Experience working at a multi-site company and/or with CMOs is helpful.

Develope analytical methods of oligonucleotides, peptides, conjugates, and small molecules.

Analyze and trend stability data, archive data.

2-4 years of experience developing theory and applications to solve challenging real-life data science problems.

Experience with designing computational methods and tools.

Prior knowledge of neuroscience and/or neurodegenerateive disease biology is preferred, but not required.

Excellent oral and written English communication skills.

Develop, implement, and apply computational tools on genomic datasets.

Work closely with biologists to interpret and understand the data.

Communicate toxicology study findings to Toxicology management and program teams in a timely manner

Additional responsibilities as assigned by the Toxicology supervisor

Strong scientific and leadership skills

Experience providing toxicology expertise on cross-functional development and discovery teams across different stages of development

Strong knowledge of GLP regulations

Current or previous Study Director experience

A leadership team that prioritizes your health and well-being; offering a remote work environment and flexible work hybrid situations

A clearly defined career framework to help you successfully manage your career

Competitive 401K and employee benefits

Leadership development and virtual training opportunities

Free financial counseling, health coaching and employee assistance program

Effective productivity/technology tools and training

Demonstrates effective project management skills.

Demonstrates broad technical program knowledge.

Develops and oversees novel scientific projects and will manage the work of others in a matrixed structure.

Independently manages workload and expectations.

Receives high level instructions on work; determines methods on new assignments; greater demonstrated independence; may manage junior staff

A minimum of 3+ years of relevant pharmaceutical industry/academic experience is required after graduation.

Manage all aspects of the GMP stability storage operations and ensuring compliance with internal procedures, industry regulations, and regulatory guidelines

Expertise and experiences in liquid chromatography and GC method development and validation is required

Demonstrated leadership skills and excellent verbal and written communication skills are essential

Excellent interpersonal and team skills are required

The ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple activities are required

Good interpersonal and communication skills

Qualifications, Knowledge And Skills Required

Possess a strong sense of time management and the ability to meet tight deadlines

Manage and coordinate analytical activities for late-stage and commercial programs.

Working knowledge of analytical methodologies used for the development and commercialization of biologics.

Understanding of product characterization and strategies to establish process and product knowledge

Ability Working within a highly matrix team (no direct supervisory responsibilities)

Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.

Some sample management might be required.

Function as the technical expert for transfer of commercial molecular biology methods and method validation in compliance with global regulatory requirements.

Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required.

Responsible for the stewardship of molecular biology methods in the Quality organization.

Uniquely Interesting Work, Life-changing Careers

Excellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective

Hands on working experience in molecular biology techniques (e.g., ELISA, Western blot, PCR/qPCR, etc.)

Experience in mouse genetic models or gene therapy is a plus

Develop and characterize mouse models to support preclinical assessment of novel therapeutic molecules.

Perform routine rodent handling and dosing, including but not limited to subcutaneous, intravenous and intraperitoneal injections.

Perform bioanalytical assay and data analysis.

Hands-on experience in bioassays, biochemical and/or biophysical assay development, qualification/validation, tech transfer and lifecycle management of methods.

Excellent data analysis and data management skills

Knowledge of the ICH and USP guidelines for assay qualification and validation.

PhD - 0-2 years of relevant experience in industry and/or academic research and development labs.

Masters 2-5 years of relevant experience in industry and/or academic research and development labs.

Bachelors 5+ years of relevant experience in industry and/or academic research and development labs.

Generate, manage, evaluate, and maintain critical data in a highly organized manner and document in paper or Electronic Laboratory notebook.

BS, 2-5 years / MS, 1-4 years relevant experience (internship experience can be included)

Hands-on experience with aseptic techniques related to mammalian cell culture (Vero and HEK293 cells lines)

Hands-on experience in laboratory techniques supporting virus, protein and DNA analysis: SDS-PAGE, Western Blot, BCA, residual DNA, HPLC, ELISA.

Excellent written and verbal communication, record keeping skills (with strong attention to detail)

Previous experience in small biotech/pharma company a plus