Sr./Scientist - Analytical Sciences

ZipRecruiter; Durham (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in biopharmaceuticals is seeking a Scientist/Senior Scientist in Analytical Sciences. This role involves analytical method development and product characterization, contributing to process development. Ideal candidates will have a strong background in laboratory practices, method development for protein therapeutics, and experience in a regulated environment.

Qualifications

• 2 years of experience in the pharmaceutical/biotech industry for Ph.D. holders.
• 6 years of experience for B.S./M.S. holders in formulation development.
• Experience in method development for protein therapeutics is critical.

Responsibilities

• Develop analytical methods including iCIEF, SEC, ELISAs, CGE.
• Author method development and qualification reports.
• Train and mentor peers in analytical methods.

Skills

Analytical method development

Sample analysis

Data analysis

Technical report authoring

Biophysical assays

Good Documentation Practices

Education

Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences

B.S./M.S. in Chemical/Biochemical Engineering or related Biological Sciences

Tools

JMP

MiniTab

Analytical instrumentation

Mass Spectrometry

Job description

Job DescriptionJob DescriptionAbout the Position

As a Scientist/Senior Scientist in Analytical Sciences, you will be a member of a growing team with talented scientists. This team is responsible for analytical method development and product characterization in support of process development for the clinical manufacturing of biopharmaceuticals (primarily mAbs). Responsibilities will include analytical method development, sample analysis, data analysis, authoring and reviewing technical reports, identifying new technologies to better support process development, supporting technology transfer into Q.C., generating documents for internal and external analytical support for manufacturing, and CMC sections of regulatory filings. Routine interactions with the cell line development, upstream process development, downstream process development, research, quality, and regulatory groups are a must. This position will help train and mentor peers in method development and sample analysis. Experience with biophysical assays (CGE, SEC, CEX, HIC, N-Glycan, Reverse Phase, Peptide Map) is a must have. The ideal candidate is also versed in GxP lab practices, including good documentation practices. The position will also be responsible for performing routine analytical testing in a quality regulated environment.

Summary of Key Responsibilities

• Responsibilities will include:

• Development of analytical methods (including iCIEF, SEC, ELISAs, CGE)

• Author method development and qualification reports

• Routine analytical analysis of process development samples

• Contribute to IND filings by authoring/reviewing relevant sections

• Generate and update SOPs

• Work as a team to maintain an organized laboratory environment

• Present analytical results at regular project meeting

• Interact with contract analytical labs and coordinate method/sample transfer activities

• Train colleagues in new techniques

• Utilizing proper Good Documentation Practices to capture and record data

• This position will help train and mentor peers in Analytical Sciences and sample analysis. The ideal candidate is also well versed in GxP lab practices.

Required Qualifications

We are looking for professionals with these required skills to achieve our goals:

1. Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 2 years of experience in the Pharmaceutical/Biotech industry in a formulation development setting for biopharmaceuticals

-or-

B.S./M.S. in in Chemical/Biochemical Engineering or related Biological Sciences with 6 years of experience in the Pharmaceutical/Biotech industry in a formulation development setting for biopharmaceuticals

• Demonstrated experience in method development for protein therapeutics

• Strong desire to work in the laboratory

• Knowledge of forced degradation conditions and stability protocol design

• Broad experience in use of analytical instrumentation (plate readers, HPLCs, capillary instruments, etc)

• Experience in authoring technical reports

• Demonstrated ability to bring in new technology and processes

• Experience with data analysis tools such as JMP & MiniTab and implementing DOE into formulation development

• Understanding of ICH/USP/EU/FDA guidelines

• Demonstrated ability to work collaboratively in a laboratory environment

• Prepared to contribute or have contributed to CMC regulatory documents

• Able to collaborate on and be a team lead on cross disciplinary teams with focuses in multiple therapeutic areas

• Experience with Mass Spectrometry is a plus