Scientist Ii Analytical Jobs in Cambridge, Middlesex, Massachusetts

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

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.

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

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.

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

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, 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

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.

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.

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.

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

10+ years of experience with database management systems such as MySQL, PostgreSQL, or MongoDB

6 years of experience analytical skills and the ability to extract insights from large sets of data

2-4 years of experience in building ML models

4-7 years of experience with programming languages such as Python or SQL

7-9 years of experience in data visualization tool such as Tableau, PowerBI, or Looker

3 years of experience with data-related libraries such as Pandas, NumPy, or Matplotlib

PhD in chemistry, chemical engineering, or a related field or MS +3 years of experience

Demonstrated experience with the design and synthesis of complex novel targets

Relevant laboratory experience in life science applications.

Experience executing molecular biology assays.

Experience in surface chemistry, polymer chemistry, bioconjugation and surface functionalization.

Experience with imaging of biological samples

The responsibilities listed are a general overview of the position and additional duties may be assigned.

Makes decisions and recommendations that have an impact on clinical research activities with minimal supervision from faculty

Formulates and conducts clinical research on problems of considerable scope and complexity

Provides clinical research expertise in an ongoing capacity

Independently interprets, organizes, executes, and coordinates clinical research assignments

Oversees the coordination of the Center’s journal club, works in progress meeting, guest lectures, and annual Alzheimer’s Disease Research Day

Understanding of testing requirements and concepts

2-4 years of work experience using either GC/MS, or GC-MSMS, with Mass Hunter software or equivalent.

Excellent verbal and written communication skills; clear, organized, detail-oriented

Offers and receives useful and constructive feedback

Undertake all necessary training to maintain the knowledge and expertise required to meet the changing demands of the position and business

Prioritize and prepare all customer samples for analytical testing according to Standard Operating Procedures (SOP)

Demonstrated scientific writing skills and strong verbal communication skills.

Synthesis, purification and characterization of ADCs on mg to gram scale under minimal supervision.

Optimization and validation of conjugation protocols and formulation buffers.

Optimization of automated techniques for ADC synthesis and purification.

Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.

Demonstrated ability to learn, understand and master new experimental techniques.

Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).

Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved

Extensive knowledge of GdPs, GMPs and DS / DP multi-compendial assays (USP, EP, JP)

Excellent communication and collaboration skills

Experience with Waters HPLC, UPLC and Beckman PA800 CE systems

Experience with ELISA based impurity or potency methods

Statistical analysis of data experience is preferred.

Must be willing to take a drug test and post-offer physical (if required).

Requirements for Scientist II BioProcess Sciences:

Assist in improving consistency, stability and yields.

Assist in optimizing current processes by conducting experiments to evaluate different growth parameters, medium components and new equipment.

Assist in setting up, operation and validation of new equipment. Ensures maintenance of equipment and it is kept in operational status.

Organization - Exercise good time management and prioritization skills

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Hands-on experience with various analytical methods such as GC, LC, LC-MS/MS, etc. to support analysis

Work cross functionally to build internal capabilities.

Analytical and Problem-Solving Skills - Able to troubleshoot critical issues and instrumentation, and determine causes and possible solutions

PhD degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 1+ years relevant experience, or

Experience with IR and AA instrumentation

H.P.L.C. and G.C. instrumentation experience

Catalent offers rewarding opportunities to further your career!

Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media.

Maintains cultures according to ATCC and departmental Standard Operating Procedures.

Performs identification of microorganisms using techniques such as API, Gram Stain, etc. Prepares reagents, standards, Medias, etc. needed for analysis.

Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)

Extensive experience in separations science (e.g., SEC, RP, IEX). Experience in Molecular biology (PCR, DNA extraction) and immunoassay (ELISA) techniques.

Experience of testing strategy for late-stage program in preparation for BLA filing

Excellent written skill for drafting all the GMP related documents.

Ensure communications occur with stakeholders and partners for all the analytical topics

Author analytical method transfer/validation related protocols and reports for late stage clinical and commercial programs.

Excellent oral (including public speaking) and written communication skills

Experience building and/or working in collaborative, diverse and inclusive team environments

Strong interpersonal skills, demonstrated through mentorship, listening and good communication

The following qualifications are required:

Develop and/or refine existing open-source aquatic algorithms for SBG, and lead their validation

Lead SBG DEIA collaborations and activities with minority and underrepresented groups

Experience with organic structural analysis and its interpretation in petrological and mineralogical context.

Experience in UV flight instrument operation and development.

This position requires the following qualifications:

The following qualifications are preferred:

For further benefits information click Benefits and Perks

PhD in geomicrobiology, or a related field.

iota offers a very competitive benefits package that includes the following:

Maintains in-depth scientific knowledge in relevant therapeutic areas

Bachelor's degree with 2+ years research experience in biology, oncology, or immunology

Experience with molecular and/or cell-based assays or histopathology

Experience in independently optimizing experimental methods and assays

Experience working in interdisciplinary environments and building relationships with key external partners

Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry or related areas with 0- 2 years industry experience

M.S. in Analytical Chemistry, Organic Chemistry, Biochemistry, or related areas with 2-4 years industry experience

More than 6 years of relevant experience with Bachelor’s degree

Must have practical experience with Mass Spectroscopy instruments such as QDa, QQQ, TOF & QTOF etc.

Experience in HPLC method development (SEC, RP, IEX, HIC etc.), , GC, for characterization of small molecules and/or large molecules characterization.

Ability to apply critical thinking and good problem-solving skills.

Ability to manage multiple priorities and comply with deadlines.

Maintains their certifications as needed for assigned job tasks.

Demonstrates strong analytical skills and logical thought processes.

Assists in troubleshooting multi-discipline problems.

Applies scientific/engineering principles applicable to assigned tasks and problem-solving.

Independently design, execute and interpret critical experiments to answer scientific questions.

Bachelor's degree in Engineering and 2 years of relevant experience, or

Master’s degree in Engineering and 1 year of relevant experience

Engineer in Training (EIT) certification

Click here for benefits information: HNTB Total Rewards

Completes assigned work within the schedule and number of hours provided.

Responsible for preparation and/or modification for select portions of project reports, plans, designs, and calculations.

Experience with Laboratory Information Management System (LIMS)

Basic computer skills (data entry and attention to detail) in Microsoft

Excellent effective written and verbal communication and interpersonal skills

Experience in biotech or pharmaceutical industry

Experience leading continuous improvement projects.

Laboratory experience, including HPLC with Empower