What are the responsibilities and job description for the Scientific Technical Reviewer II position at Boston Analytical?
JOB SUMMARY
The Scientific Technical Reviewer for Quoting conducts quantitative and qualitative analysis of
pharmaceutical methods according to the following guidelines, monographs, or policies––FDA,
ICH, USP, cGMP and Boston Analytical, Inc. The position includes technical review and
preparation of quotes for method feasibility, transfer, development and validation studies as
well as QC, raw materials and other routine testing. The position also includes development of
analytical project plans for the aforementioned studies.
PRIMARY DUTIES AND RESPONSIBILITIES
o Review of methods for the development of quotes based on requirements provided by
potential clients, sales or client services. Typical techniques include, but are not limited to
HPLC, UPLC, GC, AA, FTIR, and dissolution.
o Conducts research on products to develop quotes for method development, and
validation of new methods and test procedures.
o Conducts independent assessment of client-provided methods and develops quotes
for method development, validation, and transfer of those existing methods.
o Conducts independent assessment of client-provided Methods for stability, QC, raw
materials and other routine testing.
o Devises and develops processes and methods for the solution of technical problems.
o Confers with chemists and client personnel regarding research, procedures performed,
related results, and prepares technical portion of quotes.
o Follows all safety rules and regulations and conducts periodic safety audits.
o Ensures all appropriate work is performed in compliance with standard operating
procedures, good manufacturing practices, and the regulations of the Food and Drug
Administration and United States Pharmacopeia or other Compendial methodologies.
o Develops Project planning on projects along with Manager, establishing the approach,
timing and agreed-to timelines.
o Performs work at a level considered subject matter expert. As subject matter expert,
confers with Quality Assurance and Lab Management to design and/or improve procedures.
REQUIREMENTS & QUALIFICATIONS
o This position requires a Master’s or Bachelor’s degree in Chemistry or a related
discipline.
o Must have laboratory experience with a minimum of 3 years of experience related to
small molecule drug development, combined with a Master’s degree as described
above; or a minimum of 5 years of related work experience combined with a Bachelor’s
degree as described above, or 1 years combined with a PhD in a relevant discipline.
o Experience with analytical method development, particularly in chromatographic
methods.
o Knowledge of cGMPs and related compliance regulations and guidance’s required,
especially around requirements for analytical method development and validation.
MINIMUM SKILLS REQUIREMENTS
o Must have the ability and skill to perform the detailed job requirements noted above
competently, safely and proficiently.
o Capable of interactions with clients in presentations and in technical discussions pertaining
to prospective or existing clients.
o A self-starter, motivated person who possesses good interpersonal skills capable of
effectively interacting with all departments and client personnel.
o Must have excellent organizational, verbal communication and technical documentation
skills.
o Solid writing ability and computer skills.
o Knowledge of safe laboratory practices
o Must be a team player with integrity and concern for the quality of Company products,
services and staff members.
