Bioassay Methods Development Intern Jobs

Stay ahead of technological/scientific developments and cGxP requirements in gene therapy and biologics space.

Strong organizational skills and attention to detail

Develop de-novo, optimize/qualify potency assays (expression/function) for transfer to GMP environment

Participate in troubleshooting technical and procedural issues

Lead, guide, and work with other Scientists and Research Associates in conducting sample testing in potency assays to support multi-functional teams

Communicate/coordinate activities and priorities with relevant groups

Electronic notebook experience with ELN and NG8 system will be beneficial.

Automation experience with Hamilton, Assist plus systems will be plus.

Experience with basic Biology/Molecular biology or Biochemistry techniques

Hands-on Experience in bioassays such as cell-based assay and binding assays (ELISA/SPR) development.

Experience biochemical testing, such as enzymatic assays.

Experience with FACS, RTPCR, ddPCR, Western blot techniques.

Knowledge and hands-on experience performing and troubleshooting assays such as Sequencing, electrophoresis, PCR, Residual Protein Assays, and Cell Culture

Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements.

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations

Strong written and oral communication skills as well as organizational skills

Ability to efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

Previous experience reviewing data for GDP/GMP compliance as well as audit trail review

Previous experience managing quality records such as change controls, deviations, and lab investigations

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

Here’s What You’ll Need (Minimum Qualifications)

Proficiency and experience with scheduling, planning or project management skills, including detailed instrument and analyst scheduling.

Manages laboratory personnel and oversees their selection, performance management, mentoring, and career development

Supports resolution of sample management issues to ensure on time delivery of samples per production and testing plans.

Works with QC management and project team lead to identify and mitigate risks to meeting QC milestones and goals.

Collaborates with development groups for method transfer and qualification activities as required

Assists in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements

Reagent qualification and raw material testing.

Method development incorporating quality-by-design concept into development, qualification, and validation of bioassays per the FDA and ICH guidelines.

Experience sterile culture technique, cell preservation studies, and subsequent analytical assessment platforms for both drug substance and drug products.

Experience with client-facing tech transfer process and internal and external analyst training.

Knowledge of GMP, GxP, ICH, and 21 CFR part 11 regulations relevant to a clinical QC lab operation.

A bonus to have experience in molecular detection techniques.

Excellent organizational and time management skills

Experience with methodology and analyses for educational studies

Master’s Degree, Ph.D., and/or Ph.D. coursework in Criminal Justice, Education, Psychology, Social Work, Public Health, Sociology, or equivalent area preferred

Skills with Excel, R , or other statistical software packages

Ability to work across multiple projects and manage multiple tasks simultaneously

Strong collaboration and relationship-building skills (internally, externally, and virtually)

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Bioassay experience (ELISA, cell-based relative potency assays, PCR, Flow cytometry for method establishment and routine testing) required.

Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

Excellent written and oral communication skills.

Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.

Voluntary benefits including short & long-term disability, life, accident, critical illness insurances

Additional responsibilities and projects as required QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES: EDUCATION:

N/A OTHER KNOWLEDGE, SKILLS & ABILITIES:

Applies working knowledge of business concepts to analytical and visualization routines in Power BI

Ensures data analytics dashboards are easy to use, conforms to internal requirements, and provides value to engagement teams and clients

Applies knowledge of financial data systems to ensure our data model is structured appropriately for repeatable, reusable analytics routines

Pursuing a Masters’ degree in Accounting, Accounting Information Systems, Business Data Analytics, or Data Science, preferred EXPERIENCE:

Enforce FDA regulatory requirements including 21CFR11, 21CFR210, 21CFR211

Preferably 3-5 years laboratory experience performing ELISA and/or Bioassay within a GMP environment testing proteins and/or antibody-drug conjugates.

The candidate will be capable of learning new skills and multi-tasking independently.

Develop/transfer, validate, perform, and maintain analytical assays primarily for Bioassay and ELISA and Bioassay to characterize biomolecules for potency.

Author technical documents including test methods, equipment procedures, development reports, validation protocols/reports, and/or investigation reports.

Execute analytical methods validations in accordance with ICH Q2.