Scientist, Analytical Development

2 months ago

Waltham, United States Discover International Full time

Position: Scientist, Analytical Development (CMC Group)

Length of Contract: 12 Months

Location: Near Waltham MA


Summary: Our biotech client is seeking a versatile Scientist of Analytical Development to join the CMC team. The ideal candidate will have experience in analytical method development, product characterization, and supporting GMP biopharmaceutical manufacturing. This role involves providing analytical support for manufacturing in collaboration with CMOs and QC groups, as well as conducting in-house analytical testing for novel protein therapeutics development.


Responsibilities:

  • Develop and test potency methods such as cell-based bioassays and ELISAs.
  • Collaborate with CMOs/CROs on sample shipment, inventory tracking, and testing status.
  • Manage analytical testing activities and timelines to ensure program milestones are met.
  • Work with cross-functional teams (Research, Development, Manufacturing, Quality, Regulatory) to provide analytical support for biotherapeutics.
  • Support method development at CMOs or CROs for GMP biotherapeutic manufacturing, including protocol and report review and approval.
  • Contribute to analytical method development and biochemical characterization for all process development phases, from first-in-human to late clinical phase and commercial filings.
  • Ensure all developed methods comply with quality requirements, regulations, policies, applicable guidelines, and procedures.


Qualifications:

  • MS with 1+ years or BS with 4+ years of related experience in the pharmaceutical field, preferably with monoclonal antibodies (mAbs) and Fc-fusion proteins, and a degree in analytical science, biochemistry, or biophysics.
  • Desired experience includes chromatography, capillary electrophoresis, cell-based bioassays, ELISA, and other analytical techniques.
  • Excellent oral and written communication skills.
  • Self-motivated, with awareness of limitations and a willingness to seek clarification when needed.
  • Familiarity with regulatory guidelines for method qualification/validation and experience authoring regulatory sections for IND through BLA filings is preferred.
  • CMC/GMP Lab experience


***DO NOT CONTACT IF C2C HOUSE / EMPLOYER***

  • Scientist, Analytical Development

    2 months ago

    Waltham, United States Discover International Full time

    Position: Scientist, Analytical Development (CMC Group)Length of Contract: 12 MonthsLocation: Near Waltham MA Summary: Our biotech client is seeking a versatile Scientist of Analytical Development to join the CMC team. The ideal candidate will have experience in analytical method development, product characterization, and supporting GMP biopharmaceutical...

  • Scientist, Analytical Development Specialist

    1 week ago

    Waltham, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job OverviewThis position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Key ResponsibilitiesLead analytical technology transfers, collaborating with teams and mitigating risks.Validate analytical methods...

  • Scientist, Analytical Development 2043785

    2 weeks ago

    waltham, United States Stratacuity: Proven Scientific Placement Full time

    Location: Waltham, MA (Hybrid)Therapeutic Area: Gene TherapyJob Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Primary Job Responsibilities:Lead analytical technology transfers,...

  • Scientist, Analytical Development 2043785

    1 week ago

    Waltham, United States Stratacuity: Proven Scientific Placement Full time

    Location: Waltham, MA (Hybrid)Therapeutic Area: Gene TherapyJob Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Primary Job Responsibilities:Lead analytical technology transfers,...

  • Scientist, Analytical Development 2043785

    2 weeks ago

    waltham, United States Stratacuity: Proven Scientific Placement Full time

    Location: Waltham, MA (Hybrid)Therapeutic Area: Gene TherapyJob Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Primary Job Responsibilities:Lead analytical technology transfers,...

  • Scientist, Analytical Development 2043785

    2 weeks ago

    Waltham, United States Stratacuity: Proven Scientific Placement Full time

    Location: Waltham, MA (Hybrid)Therapeutic Area: Gene TherapyJob Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Primary Job Responsibilities:Lead analytical technology transfers,...

  • Scientist, Analytical Development

    2 months ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Principal Data Analytics Scientist

    7 days ago

    Waltham, Massachusetts, United States Dyne Tx Full time

    About Dyne TxDyne Tx is a clinical-stage biotechnology company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.Job SummaryThe Principal Data Analytics Scientist will be a critical contributor to data analytics and engineering focused on accelerating our R&D programs and expanding our...

  • Analytical Chemist, Biotechnology Development

    2 weeks ago

    Waltham, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job OverviewThis position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Key ResponsibilitiesLead analytical technology transfers, collaborating with teams and mitigating risks.Validate analytical methods...

  • Scientist II, Analytical Development

    4 weeks ago

    Waltham, Massachusetts, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...

  • Scientist II, Analytical Development

    2 months ago

    Waltham, Massachusetts, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...

  • Manager, Analytical Development

    4 weeks ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Aug As a Manager of Analytical Development, you will be joining a team of scientists responsible for managing analytical activities at CDMOs/CROs to ensure generation of high-quality and on-time data for development and registration of pre-clinical and clinical...

  • Senior Scientist I, Analytical Development

    4 weeks ago

    Waltham, Massachusetts, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...

  • Scientist - Process Research & Development

    3 weeks ago

    Waltham, United States Cambrex Full time

    Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a...

  • Lead Research Scientist

    5 days ago

    Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Job SummaryThe Principal Scientist position within Analytical Development at Alkermes, Inc. provides technical leadership for small molecule analytical methodologies and grows as a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization.Key ResponsibilitiesWork within the Analytical...

  • Senior Bioinformatics Data Scientist

    7 days ago

    Waltham, Massachusetts, United States Dyne Tx Full time

    About Dyne TxDyne Tx is a clinical-stage biotechnology company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.Job SummaryThe Principal Data Analytics Scientist is a critical contributor to data analytics and engineering focused on accelerating our R&D programs and expanding our therapeutic...

  • Senior Research Scientist

    3 days ago

    Waltham, Massachusetts, United States ThermoFisher Full time

    Job SummaryThermoFisher is seeking a highly skilled and experienced Senior Research Scientist to join our team in a key role that combines laboratory operations, quality assurance, and regulatory compliance. The ideal candidate will have a strong background in chemistry, biology, or a related field, with a minimum of 6 years of experience in laboratory...

  • Principal Scientist, Bioinformatics Data Science

    2 months ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Principal Scientist, Bioinformatics Data Science

    7 days ago

    Waltham, United States Dyne Tx Full time

    Our commitment to people with muscle diseases is our greatest strength.Principal Scientist, Bioinformatics Data ScienceDyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern...

  • Principal Scientist, Bioinformatics Data Science

    1 month ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....