Analytical Staff Scientist Jobs in 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

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.

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.

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

Collaborate with partners from engineering to customer experience to inform strategic builds of essential compliance program elements

Expert level abilities in SQL and data analysis/visualization tools (i.e. Tableau, Looker)

Deep experience using data to solve complex, ambiguous problems

Vision to define problems and manage projects in a fast-­paced, evolving organization

Paid Life insurance, AD&D, and disability benefits

Perform deep dive analysis into different customer segments and/or products to identify pockets of compliance risk

Provide technical direction to graduate students, postdocs, and research associates as appropriate, and assist in the management of research projects.

Provide users with support through your own efforts, hands-on and with your expert knowledge, in the area of electron microscopy.

Communicate with users of varying levels of experience in electron microscopy with empathy and professionalism.

Share in user-related operations, maintenance/administration, and development responsibilities within the NCEM Facility.

Strong analytical and problem-solving skills

Research experience and an established track record working in electron microscopy research at academic, industrial, or other research institutions.

Experience implementing clinical trials and/or observational studies in acupuncture and/or acupressure

Experience implementing clinical trials and/or observational studies in lifestyle modifications and cancer survivorship

Strong written and verbal communication skills

2 years of post-doctoral research experience in a related field

Experience managing project teams and managing direct reports

Experience managing Institutional Review Board approval processes

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

This position is eligible for LBNL’s Employee Referral Program benefit(s).

Lawrence Berkeley National Laboratory has multiple openings for a Chemist Staff Scientist/Engineer in Berkeley, CA.

1. Thin film semiconductor synthesis via chemical solution processing such as spin coating or blade coating;

2. Materials characterizations including spectroscopy, diffraction, and imaging tools applied during or after material synthesis;

4. Synchrotron track record on operando and in situ studies of thin film semiconductors; and

Equal Opportunity and IDEA Information Links:

Support in-house GLP/GCLP infrastructure, systems and procedures to ensure adequate thorough laboratory practices & regulatory requirements for analytical activities.

Assist in preparing detailed analytical development report to support manufacturing and regulatory requirements.

Experience with AAV, LV and Gene and/or cell therapy preferred.

Experience handling third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred.

Shown deeply understanding of global regulatory requirements including GLP, GCP and the clinical trial process.

Will critically review processes and recommend improvements to supervisor/manager.

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

Strong technical and computer skills

Bachelor's degree in Geology, Environmental Science, or other earth science related field

Self-starter, quick learner and effective communicator

Ability to work individually and as part of a team

Ability to work consecutive long days in the field under varying adverse weather conditions (hot, cold, windy, and sometimes wet)

A DAY IN THE LIFE OF A STAFF EARTH SCIENTIST

Strong project management and communication skills.

Provide guidance to less experienced researchers.

3+ years experience in the development of functional coating formulations for paper, paperboard, or other cellulosic materials.

Experience in commercialization of new products and technology solutions.

The ability to make an impact and shape your career with a company that is passionate about growth.

Ensure successful deployment of new technologies by establishing effective working relationships with sales, marketing, manufacturing, and other company researchers.

Experience working with geographically diverse collaborative groups within a clinical research environment desired

Prior knowledge of immunology, infectious diseases (e.g., polio, TB, HIV, etc.), and vaccine research would be a plus

The ideal candidate will have experience in both early- and late-phase clinical trials, and/or broad statistical methodological experience

The incumbent may perform some or all of the following responsibilities:

Contribute to infectious disease prevention and treatment science through independent and collaborative research resulting in presentations and publications

Provide statistical leadership in protocol development, monitoring, and reporting

Project management training with demonstrated project management experience

7+ years of industrial experience within the oil and gas industry

3+ years of industrial research experience within the petrochemical industry, specifically in the field of monomer processing

Experience in authoring and presenting technical papers at industry-relevant conferences or seminars

Experience in working with customers in Europe, Asia, and Middle East

Experience in business development through technical support

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.

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

Excellent project management skills and communication skills with experts and non-experts.

Proficiency with hardware control on one or more platforms (e.g., MATLAB, LabVIEW, Python, C/C++, Micro-Manager).

Experience working with optical modeling software (Zemax is preferred).

Demonstrated expertise in the design, development, and operation of optical microscopes, opto-mechanical, and opto-electronic systems.

Proficiency with one or more programming and image processing platforms (e.g., MATLAB, Python, Java/Beanshell, ImageJ, Napari, Imaris).

A track record of success with diverse interdisciplinary teams at the interface of optics and biology.