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This position will be part of Pharmaceutical Research and Development. The incumbent will participate in the development of parenteral formulation for biologics modalities such as monoclonal antibodies, antibody drug conjugates, proteins, vaccines, and viral vectors for genomic therapeutics. This position will be responsible for performing analytical characterization of candidate molecules by using various biophysical and biochemical characterization techniques. Furthermore this position will assist in developing processes for drug product manufacturing, responsible for data compilation, data presentations and report writing.
The responsibilities of Associate Scientist position include but are not limited to: Participate in developing parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody drug conjugates, proteins, vaccines, and viral vectors for genomic therapeutics. This position will be responsible to assist in developing manufacturing processes (under general supervision).
Perform rapid, comprehensive characterization of candidate molecules to determine the stability profile and applying this information to develop an appropriate dosage form to meet clinical needs. This will be achieved by applying various biophysical and biochemical techniques such as HPLC (SE-HPLC, IEX, RP-HPLC), SDSPAGE, Capillary Gel electrophoresis (CGE),imaged Capillary Electrophoresis (iCE), Spectroscopy techniques such as UV and Fluorescence spectroscopy, Circular Dichroism and FTIR.
The incumbent will assist in the development and scale-up of drug product processes from bench top to pilot scale and, as required, technology transfer to commercial plants. Examples of drug product processes are fluid transport, sterilizing filtration and lyophilization.
The Associate Scientist must be able to interact effectively with a multi-disciplinary team of scientists for formulation optimization and overall candidate progression.
This position will be responsible for preparing data summary presentation, compiling data and authoring technical reports.
Effective communication skills are desirable for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.
Bachelor's Degree in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry or equivalent with 0-3 years' experience
Up to 3 years industrial experience in parenteral formulation and process development of protein/peptide/vaccine/genomic therapeutics.
Experience with biotherapeutics analytical methods such as HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), spectroscopy techniques
Demonstrated scientific documentation skills
Knowledge of drug development processes for progression of a biological candidate.
Familiarity with GMP requirements.
Familiarity with parenteral manufacturing requirements, container/closure integrity, and clinical and commercial unit operations.
Practical knowledge of lyophilization and lyophilization cycle development
ADDITIONAL OFFER DETAILS
Additional Location Information: Andover, MA
Eligible for Employee Referral Bonus: Yes
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EEO & Employment Eligibility
Company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Company is an E-Verify employer.
Research and Development
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