Analytical Scientist Jobs in Massachusetts

Demonstrated leadership and management of high-performing teams.

Experience developing and optimizing cell-based assays with demonstrated breadth of understanding around factors influencing their performance.

Experience with ligand-binding assay development and performance (ELISA, MSD, FACS, Luminex, other)

Experience with Regulatory filings and/or agency interactions (IND, BLA, MAA and RTQ).

Experience with bioassay development and defining potency testing strategy for biotherapeutics.

Experience with mRNA or other gene therapy modalities

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.

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.

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)

Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.

Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.

Ability to communicate effectively with peers, department management and cross-functional peers.

Bachelor’s degree required, preferably in Science or equivalent combination of education and experience.

Review all data in accordance with applicable procedures and cGMP requirements.

Train new analysts to general job duties.

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 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

Utilizes the existing document management system

Requires a BS in Chemistry with 2-6 years of experience in a Quality setting

· Requires hands-on experience with sample preparation and operation of ICP for trace metals analysis

Strong understanding of GMP, ISO 9001, and other international standards is required.

Pay: $3,076.00 - $3,461.00 per month

0-2 years of experience in analytical chemistry/process development or technical operations.

Experience in chromatography techniques including IEX/RP separation, UV/MS/CAD detection

Experience with molecular biology techniques including ELISA and qPCR

Experience with integrated laboratory automation including Hamilton, Tecan, and Echo liquid handlers

Experience with laboratory supporting software including Chromeleon (or similar LC controlling software), QuantStudio, LIMS, ELN, Microsoft Office

Ability to manage multiple projects and communicate progress and challenges.