Work Location: Billerica, Massachusetts Shift: No Department: EF-ST-IA AIDD Automation Recruiter: Anthony Johnson
This information is for internals only. Please do not share outside of the organization.
Principal Scientist /Automation Biologist
Your Role:
As a member of the in AIDD team group, you will be responsible for implementing automated solutions such as liquid handlers and other automation devices to increase efficiency and throughput for bioassays (biologics assays and immunoassays). You will be responsible for onboarding and validating assays onto HT automated platforms. You will be responsible for maintaining the devices in an operable state and training others on how to use them. The Scientist is also responsible for supporting the development, qualification, transfer, and validation of analytical methods for the analysis and characterization of biologics entities.
You will be responsible to:
Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals onto a high throughput automated platform.
Create written procedures and protocols. Transfer, qualify or validate methods as needed.
Bioassay development and product characterization assays, support stability and in-process testing of a wide range of bio therapeutic modalities, including: Viral vectors, monoclonal antibodies (mAbs), ADCs, bi-specifics, cell & gene therapy, and other biologic
Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and company requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.
Location: Billerica, MA
Travel: < 10%
Who You Are:
Minimum Qualifications:
Bachelor's Degree in Cellular Biology, Cellular Bio-Chemistry, Biotechnology or related field; or equivalent education with at least 7 years of experience, or Master's Degree with at least 5 years of experience.
Hands-on experience with bioassays and functional characterization methods for monoclonal antibodies, ADCs, Bi-Specifics, various viral vectors specific titer assays & neutralization assays.
Hands-on experience with developing assays to measure various biological activities, including antigen/receptor binding, alteration of intracellular signaling, induction of cell death, and Fc effector functions
Experience with viral infectivity assays and cell and gene therapy products is a plus
Good understanding of various bio & molecular techniques such as ELISA, PCR, qPCR, ddPCR, Sequencing, etc.,
In depth knowledge and experience with bioassay development, optimization, technology transfer, assay qualification and validation following ICH guidelines
Preferred Qualifications:
PhD in Cellular Biology, Cellular Bio-Chemistry, Biotechnology or related fields
Strong experience in implementing automated Bio-Assay processes, including the use of robotic systems.
Detailed knowledge of scheduling software design and integration across an automated laboratory environment.
Experience with automation project development from concept, preliminary and final design, through construction, installation and project closure.
Comfortable working in an entrepreneurial environment, agile and face-paced teams
Self-driven, results-oriented leader with proven collaborative working style
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.